Appraisal Critically Appraised Papers Action plans and case manager support may hasten recovery of symptoms following an acute exacerbation in patients with chronic obstructive pulmonary disease (COPD) Synopsis Summary of: Trappenburg JCA et al (2011) Effect of an nurse for more information if needed, and two standardised action plan with ongoing support by a case manager on telephone reinforcement sessions at 1 and 4 months exacerbation-related outcome in patients with COPD: a following randomisation. The nurse, in consultation with multicentre randomised controlled trial. Thorax 66: 977– physician, was able to provide a course of corticosteroids 984. [Prepared by Kylie Hill, CAP Editor.] and antibiotics. Outcome measures: Patients recorded their symptoms daily and completed the 24-hour Clinical Question: In patients with COPD, does an action plan COPD Questionnaire (CCQ) every 3 days, for 6 months. (AP) with support from a case manager lead to earlier The primary outcome was time to recovery of health contact with healthcare professionals and faster recovery status following an exacerbation, defined as a return from an exacerbation? Design: Randomised, controlled to pre-exacerbation CCQ scores. Secondary outcomes trial with concealed allocation. Patients were unaware of included the time delay between exacerbation onset and the study aims. Setting: 8 regional hospitals and 5 general exacerbation-related healthcare contact and exacerbation- practices in Europe. Participants: Adults with COPD, aged related self-efficacy. Results: CCQ data were available for > 40 years, with a substantial smoking history, and using 216 patients. The mean symptom recovery time was shorter bronchodilators were eligible. Exclusion criteria were a in the AP group by 3.68 days (95% CI 0.04 to 7.32). Patients primary diagnosis of asthma or cardiac disease, or presence in the AP group with an exacerbation sought treatment 2.9 of disease that would affect mortality or participation days earlier (95% CI 2.4 to 3.5) than patients in the control (eg, confusion). Randomisation of 233 patients allocated group. The change in self-efficacy was higher in favour of 111 to the intervention group and 122 to the control the AP group. There were no differences in the number of group. Interventions: Both groups received usual care exacerbations or healthcare contact between the groups. and brief nurse-led education about management of their Conclusion: An AP with case manager support enhanced disease. In addition, the intervention group received an early detection of exacerbations and expedited recovery individualised written AP, encouragement to contact the from symptoms following these events. Commentary Whereas stand-alone COPD exacerbation action plans are used with increasing frequency, evidence is accumulating Self-management places patients and healthcare that the effectiveness of these plans without case manager professionals in partnerships. Patients are trained to be back-up and self-management training is very limited in charge of their day-to-day illness management, while (Walters et al 2010). Self-management training aimed at healthcare professionals assist with decision-making and behavioural change along with case-manager assistance goal achievement. Specialised nurses or other allied health are the strategies most likely crucial to the success of professionals often act as case managers in self-management action plans. This study underlines the usefulness of action programs for patients with chronic obstructive pulmonary plans during COPD exacerbations when coupled with case disease (COPD). Case managers can be contacted by management and implemented as part of straightforward patients if they feel they need to. self-management training programs for patients without severe co-morbid diseases. This well performed study provides additional evidence for the use of individualised written action plans for Tanja Effing exacerbations with ongoing case management in people Department of Respiratory Medicine, Repatriation with COPD. The authors hypothesised that in the event of an exacerbation, an action plan that aims at early contact with Hospital, Adelaide, Australia healthcare providers would promote prompt intervention, leading to faster recovery in symptoms and health status. References The study shows positive results for health status and symptom recovery, without an increase in the proportion of Bourbeau et al (2003) Arch Intern Med 163: 585–591. exacerbations reported to healthcare providers. The latter is somewhat surprising, but the authors indicate that a possible Effing et al (2009) Thorax 64: 956–962. explanation can be found in the increased self-efficacy (and possible better self-management strategies) and milder Rice et al (2010) Am J Respir Crit Care Med 182: 890–896. exacerbations in the intervention group. In contrast to other studies (Bourbeau et al 2003, Effing et al 2009, Rice et al Walters et al (2010) Cochrane Database Syst Rev 5: CD005074. 2010) overall health care use did not change. 60 Journal of Physiotherapy 2012 Vol. 58 – © Australian Physiotherapy Association 2012
Dentice et al: Timing of hypertonic saline and airway clearance in cystic fibrosis Adults with cystic fibrosis prefer hypertonic saline before or during airway clearance techniques: a randomised crossover trial Ruth L Dentice1,2, Mark R Elkins1,2 and Peter TP Bye1,2 1Royal Prince Alfred Hospital, 2Sydney Medical School, The University of Sydney Australia Question: Among adults with cystic fibrosis, does the timing of hypertonic saline relative to airway clearance techniques affect lung function, perceived efficacy, tolerability, or satisfaction with the entire airway clearance regimen, and is the preferred timing regimen stable over time? Design: A randomised crossover trial with concealed allocation, intention-to-treat analysis, and blinded assessors. Participants: 50 adults with cystic fibrosis and stable lung function at the end of a hospital admission. Intervention: Participants performed 3 sessions of airway clearance techniques per day for 3 days. On each day, participants were randomised to inhale hypertonic saline either before, during, or after the airway clearance techniques. Participants readmitted within one year repeated the 3-day study. Outcome measures: The primary outcome was the change in forced expiratory volume in one second (FEV1) from before to 2 hours after an entire airway clearance session. Secondary outcomes were change in forced vital capacity, perceived efficacy, tolerability, satisfaction, adverse events, and adherence. Results: All 50 participants completed the study. The effects on lung function were non-significant or were of borderline statistical significance favouring inhalation of hypertonic saline before airway clearance techniques. Satisfaction was rated significantly worse on a 100 mm scale when hypertonic saline was inhaled after the airway clearance techniques: mean differences 20mm (95% CI 12 to 29) compared to before the airway clearance techniques and 15 mm (95% CI 6 to 24) compared to during the techniques. Perceived effectiveness showed similar effects but other outcomes were unaffected. All 14 participants who were readmitted repeated the study and most preferred the same timing regimen. Conclusion: People with cystic fibrosis could be encouraged to time hypertonic saline before or during airway clearance techniques to maximise perceived efficacy and satisfaction, even though lung function may not be better with these timing regimens. Trial registration: ACTRN12611000673943. [Dentice 3- &MLJOT.3 #ZF151 \"EVMUTXJUIDZTUJDmCSPTJTQSFGFSIZQFSUPOJDTBMJOFCFGPSFPSEVSJOHBJSXBZDMFBSBODF UFDIOJRVFTBSBOEPNJTFEDSPTTPWFSUSJBMJournal of Physiotherapyo> ,FZXPSET Cystic fibrosis, Hypertonic saline, Airway clearance techniques, Lung function, Physiotherapy Introduction clearance for minutes and possibly hours (Donaldson et al 2006, Goralski et al 2010). Hypertonic saline may also Cystic fibrosis is the most common life-shortening genetic directly affect the most common infective organism in the disease in Caucasians. In Australia, 3200 people have cystic cystic fibrosis lung, Pseudomonas aeruginosa, by promoting fibrosis, of whom half are adults (Bell et al 2011). People less virulent strains and disrupting its protective biofilm with cystic fibrosis have dehydration of the airway surface, (Behrends et al 2010, Williams et al 2010). Hypertonic which impairs the clearance of normal airway secretions saline can cause transient airway narrowing, coughing, by cough and mucociliary clearance (Boucher 2007). This and pharyngeal discomfort, but these symptoms become causes chronic lung infection with recurrent exacerbations, less severe with regular use such that only about 8% of progressive lung damage, and eventual respiratory failure. people with cystic fibrosis find hypertonic saline intolerable (Elkins and Bye 2006). Airway clearance techniques, inhaled medications, and exercise are frequently used to promote mucus clearance Airway clearance techniques and hypertonic saline are often in an attempt to slow the progression of infection and lung used in a single treatment session. In clinical trials examining damage (Bye and Elkins 2007, Dwyer et al 2011, Kuys et al the efficacy of hypertonic saline, each dose has been 2011, Pryor and Prasad 2008). Physiotherapists may apply inhaled immediately before airway clearance techniques manual techniques, such as percussion and vibration, or teach independent techniques, such as breathing through 8IBUJTBMSFBEZLOPXOPOUIJTUPQJD Inhaled a positive expiratory pressure device (Elkins et al 2006a, nebulised hypertonic saline improves mucociliary Main et al 2009, van der Schans et al 2005). These clearance, lung function and quality of life in adults with techniques are believed to promote mucus clearance by cystic fibrosis. In clinical trials, hypertonic saline has accelerating expiratory airflow, reducing airway obstruction only been inhaled before airway clearance techniques. or closure, and improving the rheology of mucus (App et al 1998, Dasgupta et al 1998, Dasgupta et al 1995). Nebulised 8IBUUIJTTUVEZBEET When hypertonic saline is hypertonic saline is one inhaled medication that accelerates inhaled before or during airway clearance techniques, mucus clearance, by hydrating the airways, improving the adults with cystic fibrosis perceive the entire airway rheology of the mucus, and stimulating cough (Donaldson clearance regimen as more effective and satisfying than et al 2006, King et al 1997, Robinson et al 1997, Robinson et inhalation afterwards. Lung function is not substantially al 1996, Wills et al 1997). Restoration of airway hydration affected by the timing of hypertonic saline. Patients’ peaks immediately after an inhalation, increasing mucus preferred timing regimen is stable over time. Journal of Physiotherapy 2012 Vol. 58 – © Australian Physiotherapy Association 2012. Open access under CC BY-NC-ND license. 33
Research (Wark and McDonald 2009). However, hypertonic saline Participants could also be inhaled during or after airway clearance techniques. The timing of these two interventions could Patients were required to meet the following criteria to be potentially impact the efficacy, tolerability, convenience eligible for the study: aged at least 18 years, a diagnosis of and duration of the overall airway clearance regimen. cystic fibrosis confirmed with sweat testing or genotyping, Nebulisation of hypertonic saline before airway clearance able to perform airway clearance techniques and hypertonic techniques is often recommended to ensure the airway saline inhalation on a regular basis, and clinically stable is hydrated and mucus rheology is improved before the with a forced expiratory volume in one second (FEV1) techniques are commenced. Nebulisation during airway within 10% of the best recorded value for the past 6 months. clearance techniques could save time and may capitalise on Patients were excluded from the study if they met any of the immediate peak in the airway surface liquid volume. the following criteria: naïve to hypertonic saline, intolerant However, it could increase the complexity of the overall of hypertonic saline, lung transplant recipient, colonised airway clearance session. Nebulisation after airway with Burkholderia cepacia complex, not clinically stable, clearance techniques may capitalise on the reduction in haemoptysis greater than 60 mL within the last month, airway obstruction by mucus and therefore allow delivery thrombocytopenia, or pregnancy. Participants who were of the hypertonic saline to a greater proportion of the readmitted to hospital within one year were required to bronchial tree. However, delivering the hypertonic saline meet the same eligibility criteria before they were invited to more directly to the airway epithelium, rather than to repeat the 3-day study. overlying mucus, may reduce tolerability. Intervention The effect of the timing of hypertonic saline in relation to airway clearance techniques is yet to be investigated in a Inhalation solution: The hypertonic saline solution used controlled setting (Elkins and Dentice 2010). Furthermore, in the study was 6% hypertonic salinea. Participants were it is not known whether a person’s preferred order of instructed to inhale 4 mL of the hypertonic saline solution administration of these two interventions remains stable at each of three sessions of airway clearance techniques over time. Therefore, the research questions were: for that day. A Pari LC plus nebuliserb was given to all participants to administer their hypertonic saline. 1. Among adults with cystic fibrosis, does the timing Participants who were regularly using a bronchodilator at of hypertonic saline relative to airway clearance enrolment were advised to use their current bronchodilator techniques change the effect of an entire airway before every dose. Participants who did not usually use a clearance session on lung function? bronchodilator inhaled 200 micrograms of salbutamol sulphate via a metered dose inhalerc and a spacer deviced 2. Does the timing of hypertonic saline affect the prior to each dose of hypertonic saline. perceived efficacy, tolerability, or satisfaction with the entire airway clearance regimen? Airway clearance techniques: During the hospital admission and prior to enrolment into the study, a daily 3. Do adults with cystic fibrosis change their preferred routine of airway clearance techniques and hypertonic timing regimen over time? saline was established by an experienced respiratory physiotherapist. The techniques were chosen for each Method participant according to perceived efficacy and participant preference, and aligned with the recommended application of Design the selected techniques (McIlwaine and Van Ginderdeuren 2009). Subjects performed this airway clearance regimen A randomised, crossover trial with concealed allocation, for each session with or without an assistant as required. blinding of assessors, and intention-to-treat analysis was The duration and type of airway clearance techniques were undertaken at Royal Prince Alfred Hospital, Sydney. established in the days prior to randomisation and were Participants were recruited from among inpatients of the maintained across the three study days. Cystic Fibrosis Unit, towards the end of a hospital admission when improvements in clinical status had stabilised and a Timing regimens: When participants were allocated to daily therapy routine was well established. One investigator inhale hypertonic saline before or after airway clearance checked that each participant was performing appropriate techniques, they were advised to commence the second airway clearance techniques and tolerating hypertonic intervention as soon as the first intervention was complete. saline three times daily. On the first study day, participants When participants were allocated to inhale hypertonic were randomly allocated to perform hypertonic saline saline during airway clearance techniques, participants and either before, during, or after airway clearance techniques the treating therapist decided collaboratively if this would be at all airway clearance sessions that day. On the next day, performed by simultaneous administration or by alternating participants used the next randomly allocated timing short periods of inhalation and techniques, eg, 10–15 regimen at all airway clearance sessions. On the third day, breaths of hypertonic saline followed by airway clearance participants used the remaining timing regimen at all airway techniques, performed in cycles until the treatment session clearance sessions. Randomisation was computer generated was completed. However, participants using mouthpiece and balanced the number of participants who experienced positive expiratory pressure as their airway clearance the three timing regimens in each of the six possible orders. technique were not permitted to administer hypertonic Concealment of the allocations was achieved using sealed saline simultaneously as this alters the inhaled dose and the opaque envelopes. After the 3-day study was complete, distribution of its deposition (Laube et al 2005). Alternating participants were followed for one year to observe whether administration of these two interventions was always used they had another hospital admission. Those who had a instead. second hospital admission were invited to repeat the 3-day study to determine whether their preferred timing regimen had changed. 34 Journal of Physiotherapy 2012 Vol. 58 – © Australian Physiotherapy Association 2012. Open access under CC BY-NC-ND license.
Dentice et al: Timing of hypertonic saline and airway clearance in cystic fibrosis Patients with cystic fibrosis screened during hospital admission (n = 52) Days 1–3 Randomised to 3 timing regimens (n = 50) Excluded (n = 2) Ineligible (n = 1) Measured lung function (n = 32), perceived effectiveness, tolerability, Declined (n = 1) satisfaction, adverse events and adherence for each regimen Lost to follow-up Measured preferred timing regimen after third study day (n = 0) Participants readmitted to hospital within one year (n = 14) Excluded (n = 0) Randomised to 3 timing regimens (n = 14) Measured perceived effectiveness, tolerability, satisfaction, Lost to follow-up (n = 0) adverse events and adherence for each regimen Measured preferred timing regimen after third day Day 365 Participants not readmitted (n = 36) 'JHVSF Design and flow of participants through the trial. Participants received other usual care on all three study days, had been experienced. Effectiveness was rated on a 100 mm including all other routine therapies. Other inhaled therapies visual analogue scale with the descriptors ‘poor’ at 0 mm (eg, dornase alpha, corticosteroids) were administered at a and ‘excellent’ at 100 mm. Tolerability and satisfaction consistent time of day that was more than one hour from were also measured the same way. any of the three study periods. Typically, dornase alpha was inhaled in the morning or evening, according to patient Adverse events (such as haemoptysis, pharyngitis, and preference (Bishop et al 2011, Dentice and Elkins 2011). excessive coughing) were recorded after each treatment session. Whether an adverse event was severe enough to lead Outcome measures to intolerance of the trial intervention was also recorded. A blinded investigator questioned participants specifically Lung function was measured using a standard spirometere regarding these events. according to American Thoracic Society guidelines (American Thoracic Society 1995). The spirometric Adherence was assessed by counting unused sachets of measures recorded were FEV1 and forced vital capacity hypertonic saline, and through documentation of each (FVC), with each calculated in litres and as a percentage of session of airway clearance techniques and hypertonic saline the predicted value (Knudson et al 1983). The spirometric in the participant’s hospital case records. Furthermore, a measures were recorded prior to the second treatment physiotherapist attended each airway clearance session, session each day. Participants then had a bronchodilator, even if the airway clearance techniques were to be and then inhaled hypertonic saline either before, during, performed independently, to confirm compliance with the or after airway clearance techniques, as allocated for that allocated timing regimen. day. The spirometric measures were recorded again 2 hr after the baseline measurement, and the change in FEV1 At the conclusion of the 3-day study, participants reported and FVC over this 2-hr period for each of the study days their preferred timing regimen. was calculated. The physiotherapist who recorded the spirometric measures was kept unaware of the timing For participants who repeated the 3-day study during the regimens allocated to all participants. year of follow-up to determine if their preferred timing regimen had changed, perceived effectiveness, tolerability, The perceived effectiveness, tolerability, and satisfaction satisfaction, preferred timing regimen, adherence, and with each timing regimen were reported by participants at adverse events were measured as previously. the end of the day after all treatments using that regimen Journal of Physiotherapy 2012 Vol. 58 – © Australian Physiotherapy Association 2012. Open access under CC BY-NC-ND license. 35
Research 5BCMF Baseline characteristics of participants. –0.03 0.01 (–0.18 to 0.01) (–0.18 to 0.06) (–0.09 to 0.14) (–0.07 to 0.01) (–0.04 to 0.05) Characteristic Randomised participants After minus 0 0.02 0 Before = hypertonic saline before airway clearance techniques, During = hypertonic saline during airway clearance techniques, After = hypertonic saline after airway clearance techniques, FEV1 = during (–1 to 1) (–2 to 3) forced expiratory volume in one second, FVC = forced vital capacity Initial 3-day Repeat study 3-day study (n = 50) (n = 14) Age (yr), mean (SD) 31 (10) 30 (8) Difference between groups 2 hr minus 0 hr During minus After minus before –1 –0.06 –2 28 (56) 6 (43) (–2 to 0) (–5 to 1) Gender, n female (%) 21 (2) 21 (3) Body mass index (kg/m2), before –0.04 –1 –0.08 –2 mean (SD) 1.93 (0.78) 1.59 (0.66) (–0.08 to (–2 to 0) (–4 to 0) 57 (22) 45 (17) FEV1 (L), mean (SD) 0.00) FEV1 (% pred), mean 3.29 (1.03) 3.04 (1.02) (SD) 80 (20) 71 (14) 5BCMF Mean (SD) of groups, mean (SD) difference within groups, and mean (95% CI) difference between groups for lung function. Difference within groups After 9 (2) 9 (2) 0.05 FVC (L), mean (SD) (0.10) 6 (12) 2 (14) FVC (% pred), mean (SD) 14 (28) 3 (21) 2 30 (60) 9 (64) (3) Enrolment (day of 0.08 hospital stay), mean (SD) 23 (46) 8 (57) (0.26) 15 (30) 3 (21) 1 Outpatient bronchodilator 12 (24) 3 (21) (5) use, n (%) 2 hr minus 0 hr During nil 0.05 (0.11) occasional 2 (3) regular 0.05 (0.20) Outpatient hypertonic 1 saline use, n (%) (5) nil occasional regular FEV1 = forced expiratory volume in one second, FVC = forced vital Before capacity 0.08 (0.12) 2 (3) 0.14 (0.25) 3 (6) Data analysis After 57 (n = 32) (24) FEV1 was chosen as the primary outcome because it has 3.38 the potential to reflect both treatment efficacy and airway 2.00 (1.15) narrowing. We were unable to find an estimate of the (0.92) 81 smallest effect on FEV1 that adults with cystic fibrosis (20) would consider makes using a particular timing regimen worthwhile. However, given that the timing regimens 2 hr During 58 typically require similar time, effort, and expense, (n = 32) (24) we postulated that even a very small effect would be 3.44 worthwhile. Therefore we sought a difference of 150 mL 2.02 (1.18) between groups for the change in FEV1 across an individual (0.90) 82 treatment session. Pilot data provided a SD of 173 mL for (21) this change in FEV1 among four adults with cystic fibrosis who met the eligibility criteria. Assuming this SD, 13 Before 58 participants would provide 80% power, at the 2-sided 5% (n = 32) (24) significance level, to detect a 150 mL difference in FEV1 3.42 as statistically significant between two groups in the study. 2.03 (1.21) We increased this to 32 to allow for multiple between-group (0.91) 83 comparisons and some loss to follow-up. (22) Groups After (n = 32) 56 1.95 (24) (0.92) 3.30 (1.21) 80 (22) We also sought to have sufficient statistical power to 0 hr During 57 identify the smallest effect on satisfaction that would make (n = 32) (24) it worthwhile to use one timing regimen instead of another. 3.38 Again, given no established value and given that the timing 1.97 (1.21) regimens require similar time, effort, and expense, we (0.91) 81 nominated 10 mm on the 100 mm visual analogue scale (22) as the threshold. Assuming a SD of 20 mm (Dentice et al 2006), 34 participants would provide 80% power, at the Before 56 2-sided 5% significance level, to detect a 10 mm difference (n = 32) (24) in satisfaction as statistically significant between two groups 3.28 in the study. We increased this to 50 to allow for multiple 1.94 (1.12) between-group comparisons and some loss to follow-up. (0.89) 80 (21) Outcome FEV1 (L) FEV1 (% pred) FVC (L) FVC (% pred) 36 Journal of Physiotherapy 2012 Vol. 58 – © Australian Physiotherapy Association 2012. Open access under CC BY-NC-ND license.
Dentice et al: Timing of hypertonic saline and airway clearance in cystic fibrosis 5BCMF Mean (SD) of groups and mean (95% CI) difference between groups for perceived efficacy, tolerability and satisfaction. Outcome Groups Difference between groups Before During After During minus After minus After minus (n = 50) (n = 50) (n = 50) during before before Perceived efficacy 60 65 50 5 –11 –16 (mm) (23) (25) (22) (–1 to 11) (–19 to –3) (–24 to –8) Tolerability 61 60 58 0 –3 –2 (mm) (23) (25) (24) (–6 to 5) (–11 to 5) (–11 to 7) Satisfaction 66 61 46 –6 –20 –15 (mm) (21) (25) (22) (–14 to 3) (–29 to –12) (–24 to –6) Before = hypertonic saline before airway clearance techniques, During = hypertonic saline during airway clearance techniques, After = hypertonic saline after airway clearance techniques For spirometric data, the effect of one timing regimen is consistent with their readmission to hospital. The mean in relation to another was reported as a mean between- time between both studies was 295 days. group difference in the change from baseline to 2 hr post- baseline, with 95% CIs. Effects on efficacy, tolerability, The content of the treatment session, including tailoring and satisfaction were reported as mean between-group of the airway clearance techniques and confirming the differences with 95% CIs. The number of participants appropriate nebulisation procedures, was determined by the reporting adverse events was calculated as percentages Cystic Fibrosis Unit physiotherapist, who had 20 years of for each arm of the study. The number of participants who clinical experience, including 17 years in the cystic fibrosis preferred each timing regimen was reported as a proportion. area. The Cystic Fibrosis Unit of Royal Prince Alfred Adherence was calculated as the total number of airway Hospital, which manages approximately 250 adult patients, clearance sessions performed divided by the total number was the only centre to recruit and test patients in the trial. of sessions scheduled, and reported as a percentage. Compliance with the trial method Results According to sachet counts and hospital case records, all Flow of participants, therapists, centres through 50 participants undertook all interventions as allocated, the study except 2 (4%) participants. These 2 participants had been minimally productive of sputum after the first treatment Fifty of the 52 patients approached about participation in session of the day and therefore elected a priori to undertake the study gave consent and were eligible for the study. All only the morning and afternoon treatment sessions on each 50 participants completed the three days of interventions as study day. These participants performed two treatment randomised. After completion of this initial data collection, sessions on each of the three study days and based their each participant was followed for one year, during which 14 visual analogue scale reports on the two sessions of each participants were re-admitted to hospital for a respiratory timing regimen they experienced. Therefore adherence exacerbation. All 14 participants again met the eligibility with the allocated sessions was 99% overall. criteria and agreed to repeat the three-day study. All 14 participants completed the three days of interventions as All 50 participants had complete datasets for efficacy, randomised. The flow of participants through the trial is tolerability, and satisfaction. Due to the limited resources illustrated in Figure 1. available for using a blinded assessor, only 32 participants were allocated to undergo spirometric data collection in The characteristics of the 50 initial participants are accordance with the sample size calculation. All of these 32 presented in the first column of Table 1. The comparability participants had complete datasets for spirometric outcomes of the participants’ clinical condition at baseline on each for all three study days. of the three study days is shown in the first three columns of Table 2. Additionally, the average study day on which All 14 participants who repeated the study completed all each regimen was experienced was study day 2 (SD 1) interventions as allocated and had complete datasets for all for all three regimens, indicating successfully balanced outcomes measured. allocation of treatment orders. The range of techniques used included modified postural drainage and percussion (n Effect of intervention = 35), positive expiratory pressure (31), oscillating positive expiratory pressure (4), autogenic drainage (5), and active Group data for the measures of lung function are reported cycle of breathing techniques (28) (Pryor and Prasad 2008). in Table 2. Individual data are presented in Table 3 (see The total is greater than 50 because some participants used eAddenda for Table 3). All measures of lung function in a variety of techniques in their airway clearance session. all groups exhibited a mean increase from baseline to 2 The range of techniques for each individual participant hours post-baseline. However, there were no substantial remained standardised over the three study days. differences between the groups in the mean amount of improvement in lung function, with the between- The characteristics of the 14 participants who repeated group comparisons being either of borderline statistical the study are presented in the second column of Table 1. significance or non-significant. The results with borderline Their characteristics were typical of the initial cohort of statistical significance favoured hypertonic saline before 50 participants except their lung function was lower, which physical airway clearance techniques. Journal of Physiotherapy 2012 Vol. 58 – © Australian Physiotherapy Association 2012. Open access under CC BY-NC-ND license. 37
Research Group data for perceived efficacy, tolerability and 100% satisfaction are reported in Table 4. Individual data are presented in Table 3 (see eAddenda for Table 3). Perceived Proportion of cohort 75% After efficacy was significantly lower when hypertonic saline 50% During was inhaled after airway clearance techniques, as opposed 25% Before to before or during the techniques. Tolerability was not affected by the timing regimen used. Satisfaction with the 0% entire airway clearance regimen was significantly lower when hypertonic saline was inhaled after airway clearance 1st admission 1st admission 2nd admission techniques, as opposed to before or during the techniques. (n = 50) (n = 14) (n = 14) No adverse events were identified. No doses of hypertonic saline and no treatments with airway clearance techniques 'JHVSF. Proportion of participants who preferred each were missed due to poor tolerance. timing regimen, among the initial study cohort (n = 50) and among the cohort who repeated the 3-day study at their The proportion of participants who preferred each timing second hospital admission (n = 14). Before = hypertonic regimen is presented in the first column of Figure 2. The saline before airway clearance techniques, During = largest proportion of participants (29/50, 58%) preferred hypertonic saline during airway clearance techniques, hypertonic saline before airway clearance techniques, After = hypertonic saline after airway clearance techniques although hypertonic saline during the techniques was also popular (18/50, 36%). Few participants preferred hypertonic Hypertonic saline is known to cause a drop in lung function saline after the techniques (3/50, 6%). These proportions in some people with cystic fibrosis that typically resolves were very similar among the 14 participants who repeated by 15 min but persists in a small percentage of patients the three-day study (see the first two columns of Figure (Bye and Elkins 2007). Therefore, one limitation of this 2), indicating that they were a representative sample of study was that the effect of the timing regimen on lung the original cohort of 50 participants with regard to their function was only measured at 2 hours after baseline and preferred regimen. not 15 min after the inhalation. However, trying to measure lung function immediately after inhalation would have Among the 14 participants who repeated the three-day interrupted the entire treatment session on some days and study, perceived efficacy, tolerability, and satisfaction were not others, and this may have confounded the comparisons very similar to those reported during the initial study (data between the timing regimens. Measurement was therefore not shown) and again no adverse events occurred. Eleven standardised at 2 hours, allowing valid comparisons and of the 14 participants preferred the same timing regimen as providing important information about sustained treatment in the initial 3-day study. The proportions of participants effects. Another limitation of the study was that measures in the repeat study who preferred each regimen were very of mucus clearance were not included, which reduces the similar to the initial study (see the first and last columns of potential to understand the mechanism(s) at work in the Figure 2). different timing regimens. However, any differences in mucus clearance were too small to produce substantial Discussion differences in lung function. Therefore, the outcome measures used are adequate to guide treatment selection. This study identified that the timing of hypertonic saline in relation to airway clearance techniques did not have a The effect of the timing regimens on FEV1 was minor. substantial effect on the change in lung function after a Although some between-group comparisons were of single treatment session. However, participants were more borderline statistical significance, the mean differences satisfied with the entire treatment session when hypertonic and their 95% CIs were all well below 150 mL (the a saline was inhaled before or during the airway clearance priori smallest worthwhile effect), and equated to ≤ 2% techniques. Similarly, these timing regimens were also of the predicted normal value. Therefore, although these perceived as more effective than inhaling hypertonic borderline results favoured inhalation of hypertonic saline saline after the techniques. These differences in perceived before airway clearance techniques, any differences effectiveness and satisfaction may have important between the effects of the timing regimens on FEV1 are implications for long-term adherence, which is known to probably too small to be clinically important. However, be low for both hypertonic saline and airway clearance in the long term, clinically worthwhile differences in lung techniques (Abbott et al 2004, Elkins et al 2006b). function from the use of a particular timing regimen could occur – possibly through differences in clearance effects These results are likely to be valid because the study design and differences in adherence. This could be investigated in incorporated several features to minimise the potential future research. for bias in the results, such as concealed allocation and intention-to-treat analysis. Also, sample size calculations For FVC, the between-group comparisons were again either for the primary outcome and one secondary outcome of borderline statistical significance or were non-significant. were performed and the required cohorts were recruited. However, unlike the narrow confidence intervals seen in Furthermore, there was no loss to follow-up and compliance with the trial method was excellent. Potential bias was also reduced by blinding the assessors of the primary outcome. The stability of the results of this trial over time suggest that the initial results were not a chance finding. 38 Journal of Physiotherapy 2012 Vol. 58 – © Australian Physiotherapy Association 2012. Open access under CC BY-NC-ND license.
Dentice et al: Timing of hypertonic saline and airway clearance in cystic fibrosis the FEV1 data, some of the between-group comparisons HREC/09/RPAH/477). All participants gave written for FVC had 95% CIs that did not exclude the possibility informed consent before data collection began. of substantial effects. For example, inhaling hypertonic saline before airway clearance techniques might increase Competing interests: None. the improvement in FVC by as much as 180 mL more than inhaling it during or after the techniques. Therefore, further Support: This study was supported by the NHMRC CCRE data could be obtained to make the estimate of the effect in Respiratory & Sleep Medicine Postgraduate Research on FVC more precise and then to determine whether it is Scholarship and the US Cystic Fibrosis Foundation grant large enough to be clinically worthwhile. As with FEV1, the BYE04A0. effect of long-term use of a timing regimen on FVC could also be investigated. Acknowledgements: The authors are grateful to the participants for their involvement and the Department of Perceived efficacy and satisfaction were significantly Physiotherapy at Royal Prince Alfred Hospital. lower when hypertonic saline was inhaled after airway clearance techniques than with the other timing regimens. Correspondence: Ruth L Dentice, Physiotherapy Inhalation of hypertonic saline after the techniques may Department, Royal Prince Alfred Hospital, Australia. fail to capitalise on effects of hypertonic saline on mucus Email: [email protected] clearance if techniques to promote expectoration are not undertaken until 4–6 hours later. Although these results References were statistically significant, some may not be clinically worthwhile because the 95% CIs contain effects smaller Abbott J, Dodd ME, Webb AK (2004) Adherence with the use than the a priori smallest worthwhile effect of 10 mm on of clearance techniques. In Rubin BK, van der Schans CP the 100 mm visual analogue scale. However, the effect (Eds) Therapy for Mucus-Clearance Disorders, Vol 188. New of inhaling hypertonic saline before rather than after the York: Marcel Dekker, pp 105–128. techniques increased satisfaction by 20 mm (95% CI 12 to 29), which clearly exceeds the smallest worthwhile effect. American Thoracic Society (1995) Standardization of spirometry: 1994 Update. American Journal of Respiratory & The data did not support our hypothesis that inhaling Critical Care Medicine 152: 1107–1136. hypertonic saline after airway clearance techniques would reduce tolerability. We expected that inhaling the hypertonic App EM, Kieselmann R, Reinhardt D, Lindemann H, Dasgupta saline after the techniques may have delivered it to a more B, King M, et al (1998) Sputum rheology changes in cystic exposed airway epithelium because the amount of overlying fibrosis lung disease following two different types of mucus would be minimised. However, this timing regimen physiotherapy: flutter vs autogenic drainage. Chest 114: did not reduce subjective or objective tolerability. 171–177. The absence of adverse events, the lack of intolerance, and Behrends V, Ryall B, Wang X, Bundy JG, Williams HD the excellent adherence indicate that any of the three timing (2010) Metabolic profiling of Pseudomonas aeruginosa regimens is feasible among adults with CF who regularly demonstrates that the anti-sigma factor MucA modulates use hypertonic saline and airway clearance techniques. osmotic stress tolerance. Molecular Biosystems 6: 562–569. However, this level of adherence may differ in the longer term or among users who are new to the interventions. Bell SC, Bye PT, Cooper PJ, Martin AJ, McKay KO, Robinson PJ, et al (2011) Cystic fibrosis in Australia, 2009: results from On the basis of these results, we suggest that clinicians a data registry. 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Research maintaining health in cystic fibrosis. Current Opinion in Main E, Prasad A, van der Schans CP (2009) Conventional Pulmonary Medicine 6: 455–460. chest physiotherapy compared to other airway clearance techniques for cystic fibrosis. Cochrane Database of Elkins MR, Bye PT (2006) Inhaled hypertonic saline as a Systematic Reviews Issue 1. Art. No.: CD002011. DOI: therapy for cystic fibrosis. Current Opinion in Pulmonary '&$'&&(%'*,+'.+.$9:&&(&''$fkX($ Medicine 12: 445–452. McIlwaine MP, Van Ginderdeuren F (2009) Physiotherapy for Elkins MR, Jones A, van der Schans C (2006a) Positive people with Cystic Fibrosis: from infant to adult (4th ed). expiratory pressure physiotherapy for airway clearance International Physiotherapy Group for Cystic Fibrosis. www. in people with cystic fibrosis. Cochrane Database of Y\\mm$eh]%_f]#Y\\% Systematic Reviews Issue 2. Art. No.: CD003147. DOI: '&$'&&(%'*,+'.+.$9:&&)'*-$fkX)$ Pryor JA, Prasad SA (2008) Physiotherapy Techniques (Ch 5). In Pryor JA, Prasad SA (Eds) Physiotherapy for Respiratory Elkins MR, Dentice RL (2010) Timing of hypertonic saline and Cardiac Problems (4th edn). Edinburgh: Churchill inhalation for cystic fibrosis. Cochrane Database of Livingstone. Systematic Reviews Issue 11. Art. No.: CD008816. DOI: '&$'&&(%'*,+'.+.$9:&&..',$ Robinson M, Hemming AL, Regnis JA, Wong AG, Bailey DL, Bautovich GJ, et al (1997) Effect of increasing doses of Elkins MR, Robinson M, Rose BR, Harbour C, Moriarty CP, hypertonic saline on mucociliary clearance in patients with Marks GB, et al (2006b) A controlled trial of long-term cystic fibrosis. Thorax 52: 900–903. inhaled hypertonic saline in patients with cystic fibrosis. New England Journal of Medicine 354: 229–240. Robinson M, Regnis JA, Bailey DL, King M, Bautovich GJ, Bye PT (1996) Effect of hypertonic saline, amiloride, and cough Goralski JL, Boucher RC, Button B (2010) Osmolytes and on mucociliary clearance in patients with cystic fibrosis. ion transport modulators: new strategies for airway surface American Journal of Respiratory & Critical Care Medicine rehydration. Current Opinion in Pharmacology 10: 294–299. 153: 1503–1509. King M, Dasgupta B, Tomkiewicz RP, Brown NE (1997) van der Schans C, Prasad A, Main E (2005) Chest Rheology of cystic fibrosis sputum after in vitro treatment physiotherapy compared to no chest physiotherapy for cystic with hypertonic saline alone and in combination with fibrosis. Cochrane Database of Systematic Reviews Issue recombinant human deoxyribonuclease I. American Journal ($7hj$De$09:&&'*&'$:E?0'&$'&&(%'*,+'.+.$9:&&'*&'$ of Respiratory & Critical Care Medicine 156: 173–177. Wark PAB, McDonald V (2009) Nebulised hypertonic saline Knudson RJ, Lebowitz MD, Holberg CJ, Burrows B (1983) for cystic fibrosis (Cochrane Review). Cochrane Database Changes in the normal maximal expiratory flow-volume of Systematic Reviews Issue 2. Art. No.: CD001506. DOI: curve with growth and aging. American Review of Respiratory '&$'&&(%'*,+'.+.$9:&&'+&,$fkX)$ Disease 127: 725–734. Williams HD, Behrends V, Bundy JG, Ryall B, Zlosnik JE (2010) Kuys SS, Hall K, Peasey M, Wood M, Cobb R, Bell SC (2011) Hypertonic saline therapy in cystic fibrosis: do population Gaming console exercise and cycle or treadmill exercise shifts caused by the osmotic sensitivity of infecting bacteria provide similar cardiovascular demand in adults with explain the effectiveness of this treatment? Frontiers in cystic fibrosis: a randomised cross-over trial. Journal of Microbiology 1: 120. Physiotherapy 57: 35–40. Wills PJ, Hall RL, Chan WM, Cole PJ (1997) Sodium chloride Laube BL, Geller DE, Lin TC, Dalby RN, Diener-West M, Zeitlin increases the ciliary transportability of cystic fibrosis and PL (2005) Positive expiratory pressure changes aerosol bronchiectasis sputum on the mucus-depleted bovine distribution in patients with cystic fibrosis. Respiratory Care trachea. Journal of Clinical Investigation 99: 9–13. 50: 1438–1444. 40 Journal of Physiotherapy 2012 Vol. 58 – © Australian Physiotherapy Association 2012. Open access under CC BY-NC-ND license.
Robledo-Colonia et al: Exercise during pregnancy and depression Aerobic exercise training during pregnancy reduces depressive symptoms in nulliparous women: a randomised trial Angelo Fernando Robledo-Colonia, Natalia Sandoval-Restrepo, Yannier Ferley Mosquera- Valderrama, Celia Escobar-Hurtado and Robinson Ramírez-Vélez University of Valle, Cali, Colombia Question: Does supervised aerobic exercise during pregnancy reduce depressive symptoms in nulliparous women? Design: Randomised trial with concealed allocation, blinded assessors, and intention-to-treat analysis. Participants: 80 nulliparous, pregnant women attending for prenatal care at one of three tertiary hospitals in Cali, Colombia. Intervention: The experimental group completed a 3-month supervised exercise program, commencing at 16 to 20 weeks of gestation. Each session included walking (10 min), aerobic exercise (30 min), stretching (10 min), and relaxation (10 min). The control group continued usual activities and performed no specific exercise. Outcome measures: The primary outcome was symptoms of depression assessed by the Center for Epidemiological Studies Depression Scale (CES-D) at baseline and immediately after the 3-month intervention. Results: 74 women completed the study. After the 3-month intervention, the experimental group reduced their depressive symptoms on the CES-D questionnaire by 4 points (95% CI 1 to 7) more than the control group. Conclusions: A supervised 3-month program of primarily aerobic exercise during pregnancy reduces depressive symptoms. Trial registration: NCT00872365. <3PCMFEP$PMPOJB\"' 4BOEPWBM3FTUSFQP/ .PTRVFSB7BMEFSSBNB:' &TDPCBS)VSUBEP$ 3BN®SF[ 7²MF[ 3 \"FSPCJD FYFSDJTF USBJOJOH EVSJOH QSFHOBODZ SFEVDFT EFQSFTTJWF TZNQUPNT JO OVMMJQBSPVT XPNFO BSBOEPNJTFEUSJBMJournal of Physiotherapyo> Key words: Aerobic exercise, Pregnant women, Depression, Randomised trial, Physiotherapy Introduction supported the popular belief that physical activity is associated with psychological health in pregnant women. Depression disorders have become a widespread health Guidelines from the American College of Obstetricians concern throughout the world. The worldwide prevalence and Gynecologists (Artal and O’Toole 2003) recommend of depression has been estimated at 10.4% (Andrews et al regular exercise for pregnant women, including those 2000). During pregnancy, depression affects 10–50% of who are sedentary, for its overall health benefits including women, with the incidence being higher in cohorts with low improved psychological health. Physical activity during socioeconomic status (De Tychey et al 2005). Depression pregnancy appears to be beneficial to the maternal-foetal during pregnancy is more common among women with a unit and may prevent the occurrence of maternal disorders, history of depression or a family history of depression, those such as hypertension (Yeo et al 2000, Barakat et al 2009) in single motherhood or with more than three children, and gestational diabetes (Dempsey et al 2004, Callaway cigarette smokers, low income earners, teenagers, and those et al 2010), as well as improving well-being and quality of in unsupportive social situations (Dietz et al 2007, Yonkers life (Montoya Arizabaleta et al 2010). In addition, several et al 2009). The importance of prenatal intervention is studies over the last decade have reported that physical highlighted by studies showing that depression is associated activity has few negative effects for many pregnant women with increased risk of prenatal and perinatal complications (Alderman et al 1998, Artal and O’Toole 2003, Barakat et (Jablensky et al 2005, Nakano et al 2004). For example, al 2008, Barakat et al 2009). depressed women are more likely to deliver prematurely (Field 2011) and they often have neonates who require Pregnancy is a time of intense physical change and emotional intensive care for postnatal complications including growth upheaval in many women (Hueston and Kasik-Miller 1998, retardation and bronchopulmonary dysplasia (Chung et al Montoya Arizabaleta et al 2010). In addition to the obvious 2001). Furthermore, although pregnant women typically outward physical changes that accompany pregnancy, report significantly lower rates of tobacco, alcohol, and significant increases in mental health problems, including cannabis use than before pregnancy (Hotham et al 2008), depression increases vulnerability to caffeine, nicotine, 8IBUJTBMSFBEZLOPXOPOUIJTUPQJD Depression is drug, and alcohol use in pregnant women (De Tychey et common among pregnant women and is associated al 2005, Field et al 2009). Depression is also associated with increased risk of prenatal and perinatal with failure to eat well and seek prenatal care (Yonkers et complications. Exercise is an effective therapy for al 2009). depression in many other patient populations. Prenatal interventions for depressed pregnant women 8IBUUIJTTUVEZBEET Three months of aerobic have included antidepressants, psychotherapy, alternative exercise training reduces the severity of symptoms of therapies, and physical activity (Field et al 2009, Rethorst depression among pregnant women. et al 2009). In recent years, accumulating evidence has Journal of Physiotherapy 2012 Vol. 58 – © Australian Physiotherapy Association 2012. Open access under CC BY-NC-ND license. 9
Research depression and psychosis, occur during pregnancy and in Medicine (ACSM 2009) and the American College of the immediate postpartum period (Watson et al 1984). Even Obstetricians and Gynecologists (Artal and O’Toole 2003). in normal pregnancies, women experience subtle changes that may alter their ability to carry out their usual roles and At each participating centre two health professionals, may detract from their overall health-related quality of life who volunteered, were trained to recruit and assess (Hueston and Kasik-Miller 1998, Montoya Arizabaleta et eligibility. During the recruitment period, the opportunity al 2010). Research has shown that exercise can decrease to participate in the study was offered daily to all patients depressive symptoms, yet an optimal exercise program for at the participating centres when they attended for routine treating depression has not been established. antenatal care, if they previously had been identified on the doctors’ lists as being without a chronic pathology. Therefore the research question for this study was: The participating centres were required to offer routine Does a 3-month supervised aerobic exercise program antenatal care and have facilities to allow the conduct of a decrease depressive symptoms in nulliparous pregnant supervised exercise class. women? Intervention Method Participants in the experimental group were invited to A randomised trial was conducted. Participants were participate in three 60-min exercise classes per week, recruited from the prenatal care services of three hospitals starting between week 16 and 20 of gestation and continuing in Cali, Colombia. Women who were interested in the for 3 months. All subjects wore a heart-rate monitor during study were invited to a screening visit at one of the centres. the training sessions to ensure that exercise intensity was Sociodemographic data were recorded and a detailed moderate to vigorous (Ramírez-Vélez et al 2009, Ramírez- physical examination was performed by a physician to Vélez et al 2011b). Sessions consisted of walking (10 min), determine eligibility. After confirmation of eligibility, the aerobic exercise (30 min), stretching (10 min), and relaxation women were randomly allocated to one of two groups: (10 min). Aerobic activities were prescribed at moderate to aerobic exercise plus usual prenatal care, or usual prenatal vigorous intensity, aiming for 55–75% of maximal heart rate care only. Randomisation was performed using a permuted and adjusted according to ratings on the Borg scale (Borg block design with a block size of 10 and exp:con ratios of 5:5, 1982). Adherence to the exercise program was encouraged 6:4 or 4:6. Participants in the exercise group commenced by the physiotherapist who supervised the exercise sessions. the program when each block was completed, allowing In order to maximise adherence to the training program, supervised group exercise sessions comprising three to five all sessions were: supervised by a physiotherapist and a women. Baseline measures were taken the day before the physician, conducted in groups of three to five women, exercise program commenced and outcomes were measured accompanied by music, and performed in a spacious, air- the day after the program was completed. The investigator conditioned room. responsible for randomly assigning participants to treatment groups did not know in advance which treatment the next The control group received no exercise intervention, did not person would receive (concealed allocation) and did not attend the exercise classes, and did not take part in a home participate in administering the intervention or measuring exercise program. Both groups continued with their normal outcomes. The investigators responsible for assessing prenatal care (1 session per week for 3 months) and physical eligibility and baseline measures were blinded to group activity. allocation. Participants and therapists administering the intervention were not blinded. The investigators responsible Outcome measures for outcome assessment were blinded to group allocation. All investigators received training before the trial and One day before beginning the exercise program and reminders during the trial regarding the protocol, the immediately after the 3-month exercise period finished, measurement procedures, and the methods and importance all women were assessed for symptoms of depression of maintaining blinding. Measurements were taken at using the Center for Epidemiological Studies-Depression baseline (Month 0, which corresponded to 16–20 weeks of Scale (CES-D). The 20-item scale has adequate test-retest gestation) and at the end of the three-month intervention reliability, internal consistency, and concurrent validity period (Month 3, week 28–32 of gestation). (Wells et al 1987). Test-retest reliability over a one-month period on this sample was 0.79, suggesting some short- Participants, therapists, centres term stability of depressive symptoms. A score of 16 on the CESD is considered the cut-point for depression (Radloff Pregnant women were eligible for the study if they were and Rae 1979). aged between 16 and 30 years, between 16 and 20 weeks of gestation, with a live foetus at the routine ultrasound scan. Data analysis They were excluded if they had participated in a structured exercise program in the past six months or had a history We sought to detect a between-group difference in the of high blood pressure, chronic medical illnesses (cancer, change in the CES-D score of 4 points as we considered renal, endocrine, psychiatric, neurologic, infectious, this a clinically important improvement in depressive or cardiovascular diseases), persistent bleeding after symptoms. Assuming that the standard deviation in this week 12 of gestation, poorly controlled thyroid disease, score would be 6, similar to that observed in a similar placenta praevia, incompetent cervix, polyhydramnios, sample of women during pregnancy (Carter et al 2000), a oligohydramnios, miscarriage in the last 12 months, or total sample size of 74 would provide 80% power to detect diseases that could interfere with participation, according a difference of 4 points as statistically significant. We to the recommendations of the American College of Sports recruited additional participants to allow for withdrawals. Data were entered in an electronic database by investigators at the time of assessment. Random checks of data entry 10 Journal of Physiotherapy 2012 Vol. 58 – © Australian Physiotherapy Association 2012. Open access under CC BY-NC-ND license.
Robledo-Colonia et al: Exercise during pregnancy and depression 5BCMF Baseline characteristics of participants, therapists, and centres. Characteristic Study completers Lost to follow-up (n = 74) (n = 6) Exp Con Exp Con (n = 37) (n = 37) (n = 3) (n = 3) Participants 21 (3) 21 (2) 21 (2) 17 (1) 18 (1) 17 (1) Age (yr), mean (SD) 21 (3) 17 (46) 1 (33) 2 (66) Gestation (wk), mean (SD) 18 (2) 20 (54) 2 (66) 1 (33) Marital status, n (%) 6 (16) 1 (33) 2 (66) 31 (84) 2 (66) 1 (33) Single 11 (30) CWhh_[Z%Z[\\WYje 26 (70) 31 (84) 2 (66) 1 (33) 6 (16) 1 (33) 2 (66) Ethnicity, n (%) 3 (8) 1 (33) 0 African Colombian 2 (5) 7 (19) 0 1 (33) 24 (65) 1 (33) Mestize 35 (95) 3 (8) 1 (33) 1 (33) 1 (33) Socioeconomic level, n (%) 0 0 0 Stratum 1 (range 1–3) 35 (95) 5 (14) 2 (66) 32 (86) 3 (100) 1 (33) Stratum 2 (range 4–6) 2 (5) 0 33 (89) 3 (100) Education, n (%) 4 (11) 1 (33) 0 2 (66) None 2 (5) 10 (27) 1 (33) 9 (24) 1 (33) 1 (33) Primary 5 (14) 8 (22) 1 (33) 1 (33) 10 (27) 1 (33) Secondary 25 (68) 0 13 (35) 0 Technical 4 (11) 12 (32) 1 (33) 12 (32) 1 (33) 1 (33) University 1 (3) 2 (66) 1 (33) Occupation, n (%) 0 Student 9 (24) Housewife 28 (76) Location, n (%) Urban 35 (95) Rural 2 (5) Therapists, n participants (%) A 10 (27) B 10 (27) C 9 (24) D 8 (22) Centres, n participants (%) 1 12 (32) 2 12 (32) 3 13 (35) Exp = experimental group, Con = control group were performed and corrections made where possible by Results phoning participants for confirmation. The normality of the distribution of scores was confirmed with the Kolmogorov- Flow of participants, therapists, centres through Smirnov test. We then used the unpaired t-test to estimate the study the between-group difference. The significance level was set at p < 0.05. Analysis was according to the principle of Eighty participants were recruited to the study. The baseline intention-to-treat. characteristics are presented in Table 1. Forty participants were allocated to the experimental group and 40 to the control group. Figure 1 outlines the flow of participants through the trial and the reasons for loss to follow-up. Journal of Physiotherapy 2012 Vol. 58 – © Australian Physiotherapy Association 2012. Open access under CC BY-NC-ND license. 11
Research Pregnant women assessed for eligibility (n = 550) Excluded (n = 460) ineligible (n = 420) declined (n = 5) no contact (n = 25) other (n = 10) Screened (n = 90) Excluded (n = 10) risk for premature labour (n = 7) pregnancy-induced hypertension (n = 1) persistent bleeding (n = 1) personal reasons (n = 1) Month 0 Measured depressive symptoms Randomised (n = 80) (n = 40) (n = 40) Lost to follow-up (n = 3) Experimental Group Control Group Lost to follow-up (n = 3) relocated outside usual activities and usual activities and relocated outside area area (n = 3) antenatal care antenatal care (n = 1) walking (10 min) no specific exercise did not return for prenatal aerobic exercise (30 care (n = 1) min) stretching (10 min) relaxation (10 min) became privately insured and changed health care )i[ii_edi%m[[an) provider (n = 1) months Month 3 Measured depressive symptoms (n = 37) (n = 37) 'JHVSF Design and flow of participants through the study. A qualified, registered physiotherapist and a medical 3-month assessment. In all cases the withdrawals were doctor with four years of experience in exercise programs, due to reasons unrelated to the intervention. Experimental supervised all exercise sessions. In addition, the participants received on average 28.9 out of 36 (SD 3.2) physiotherapist received further training in the specific sessions over the 3 months. No adverse events occurred exercise program for this study. during or after the exercise in any participant. The study was conducted at three hospitals specialising in Effect of intervention antenatal care, which were located in different regions of Cali, Colombia (Hospital Cañaveralejo, Centro de Salud Group data are presented in Table 2 and individual data Siloe, and Centro de Salud Melendez), with a combined in Table 3 (see eAddenda for Table 3). At 3 months, the throughput of 1200 pregnant women per year. supervised aerobic exercise program reduced depressive symptoms significantly more in the experimental group Compliance with the trial method than the control group. The between-group difference in improvement was 4 points (95% CI 1 to 7) on the 20-point Three participants in the experimental group and three CES-D score. in the control group withdrew from the study before the 12 Journal of Physiotherapy 2012 Vol. 58 – © Australian Physiotherapy Association 2012. Open access under CC BY-NC-ND license.
Robledo-Colonia et al: Exercise during pregnancy and depression 5BCMF Mean (SD) of groups, mean (SD) difference within groups, and mean (95% CI) difference between groups for depressive symptoms by (CES-D) Groups Difference within groups Difference between groups Month 0 Month 3 Month 3 minus Month 0 Month 3 minus Month 0 Exp Con Exp minus Con Exp Con Exp Con (n = 37) (n = 37) (n = 37) (n = 37) –5 –1 –4 (5) (8) (–1 to –7) CES-D points 16 17 10 16 (8) (7) (6) (8) Exp = experimental group, Con = control group, CES-D = Center for Epidemiological Studies Depression Scale Discussion depression during pregnancy may therefore be useful in motivating pregnant women to exercise during pregnancy A recent systematic review of the effect of exercise on and in breaking these cycles of reinforcement between antenatal depression found a small number of observational depression and overall fitness. studies linking regular physical activity to improved self- esteem and reduced symptoms of anxiety and depression The results of this study are consistent with several previous during pregnancy (Shivakumar et al 2011). However, no studies of the effect of structured exercise on depression in randomised controlled trials were identified by this review. other populations. A systematic review by Rethorst and Therefore, we believe this is the first randomised trial to colleagues (2009) reported that aerobic exercise at a dose assess the effect of a supervised aerobic exercise program consistent with public health recommendations (ie, at least on depressive symptoms in nulliparous pregnant women. 30 minutes of moderate intensity physical activity on most, preferably all, days of the week) is an effective monotherapy Our study showed that three months of aerobic exercise for symptoms of depression. Results from review articles reduces symptoms of depression in pregnant women. In and meta-analyses also indicate an inverse relationship our clinical experience, we consider that a reduction of between physical activity and depressive symptoms 4 points on the CES-D resulting from this intervention (Paluska and Schwenk 2000, Rethorst et al 2009, Carek is clinically important. However, no threshold has been et al 2011). In Rethorst’s meta-analysis (2009), the effect established empirically for the amount of improvement of exercise was also examined specifically in individuals in the CES-D score that pregnant women typically feel with clinical depression or depression resulting from makes aerobic training worthwhile. Our estimate of the mental illness. The results showed that exercise programs average effect of the training had some uncertainty, with were effective in decreasing depressive symptoms among a 95% CI ranging from 1 to 7 points. Therefore, even if clinically depressed individuals and individuals with 4 points is a valid estimate for the smallest worthwhile depression resulting from mental illness. effect, we must acknowledge that it is uncertain whether the statistically significant effect of aerobic exercise is clinically Another study by Craft (2007) compared the effects of worthwhile. Nevertheless, aerobic exercise training during two exercise programs on physical activity, depressive pregnancy is associated with other clinical benefits such as symptoms, body composition, and fitness. Thirty-two the prevention of maternal hypertension (Yeo et al 2000, sedentary women with a diagnosis of depression were Barakat et al 2009) and gestational diabetes (Dempsey et randomised to either a clinic-based or a home-based al 2004, Callaway et al 2010), as well as improved well- exercise program for three months. The results showed that being and quality of life (Ramírez-Vélez 2011a, Montoya both exercise programs were associated with reductions Arizabaleta et al 2010). Therefore, physiotherapists can in depressive symptoms and increased physical activity prescribe aerobic exercise during pregnancy for its range of participation. Neither exercise program impacted body benefits, now knowing that it will also reduce the severity composition or fitness. The authors concluded that both of any depressive symptoms. clinic-based and home-based exercise programs can benefit women with depressive symptoms. Observational studies of risk factors for depression during pregnancy cannot determine causation. However, it is During pregnancy, symptoms are an important contributor possible that some of the factors identified may enter into to poor health status, while in the postpartum period a lack a reinforcing cycle with depression. For example, low of social support is the most consistent predictor of poor levels of physical activity, self-care ability, and antenatal health outcomes (Hueston and Kasik-Miller 1998). The support are associated with depression in pregnant women recommended levels of physical activity were positively (Demissie et al 2011). Low levels of physical activity associated with reduced depressive symptoms. In particular, may reduce cardiovascular fitness and affect motivation social functioning, and mental health are critically affected to stay healthy physically, mentally, and emotionally. by the recommended level of physical activity (Brown et al This could be exacerbated by the lack of energy often 2003). experienced by pregnant women. Lower ability to self-care during pregnancy may increase musculoskeletal or other Our estimate of the effect of aerobic exercise on depression physical barriers to exercise. The impact of depression can is likely to be valid because the study design incorporated exacerbate an unhealthy lifestyle, resulting in prenatal and features such as concealed allocation and intention-to-treat perinatal complications, which in turn can lead to more analysis in order to minimise the potential for bias in the severe depression. The information that exercise reduces results. Only one outcome was measured so the risk of Type Journal of Physiotherapy 2012 Vol. 58 – © Australian Physiotherapy Association 2012. Open access under CC BY-NC-ND license. 13
Research I error was low. The required sample size was calculated a of Obstetricians and Gynecologists for exercise during priori and was attained, with little attrition from the study pregnancy and the postpartum period. British Journal of cohort during the trial period. Nevertheless, our findings Sports Medicine 37: 6–12. should be considered within the context of the limitations of the study design. One limitation was that the therapists and Barakat R, Ruiz JR, Stirling JR, Zakynthinaki M, Lucia A (2009) participants were not blinded. Further studies may be needed Type of delivery is not affected by light resistance and toning to explore the relationships among psychological status, exercise training during pregnancy: a randomized controlled physical function, and quality of life during pregnancy with trial. American Journal of Obstetrics and Gynecology 201: depressive symptoms (Brown et al 2000, Ramírez-Vélez et 1–6. al 2011a, Montoya Arizabaleta et al 2010). Investigation of other intervention components, such as behaviour therapy, Barakat R, Stirling JR, Lucia A (2008) Does exercise training is also needed (Field et al 2009, Rethorst et al 2009). In during pregnancy affect gestational age? A randomised addition, future randomised controlled trials should study controlled trial. British Journal of Sports Medicine 42: 674– the effects of exercise in pregnancy among women with low 678. pre-pregnancy physical activity. Borg GA (1982) Psychophysical bases of perceived exertion. Physiotherapists should advise pregnant women that aerobic Medicine and Science in Sports and Exercise 14: 377–381. exercise training during pregnancy reduces the severity of symptoms of depression. It is unclear whether the effect on Brown DW, Balluz LS, Heath GW, Moriarty DG, Ford ES, Giles depression alone is large enough for pregnant women to feel WH, et al (2003) Associations between recommended levels it justifies the time, effort and cost of the exercise regimen. of physical activity and health-related quality of life. Findings However, the effect on depression is supplemented by from the 2001 Behavioral Risk Factor Surveillance System preventive effects on maternal hypertension and gestational (BRFSS) survey. Preventive Medicine 37: 520–528. diabetes, as well as improved well-being and quality of life. Q Brown WJ, Mishra G, Lee C, Bauman A (2000) Leisure time physical activity in Australian women: relationship with well- eAddenda: Table 3 available at JoP.physiotherapy.asn.au being and symptoms. Research Quarterly for Exercise and Sport 71: 206–216. Ethics: The University of Valle Research Ethics Committee approved this study (Res-021/010-UV). Informed consent Callaway LK, Colditz PB, Byrne NM, Lingwood BE, Rowlands was gained from all participants before data collection IJ, Foxcroft K, et al (2010) Prevention of gestational diabetes: began. feasibility issues for an exercise intervention in obese pregnant women. Diabetes Care 33: 1457–1459. Support: COLCIENCIAS (Grant No 1106-45921540). Carek PJ, Laibstain SE, Carek SM (2011) Exercise for the Acknowledgements: The authors would like to acknowledge treatment of depression and anxiety. International Journal of Instituto Colombiano para el Desarrollo de la Ciencia y la Psychiatry in Medicine 41: 15–28. Tecnología ‘Francisco José de Caldas’ COLCIENCIAS for the financial support to the Nutrition Group (Grant No Carter AS, Wood Baker C, Brownell KD (2000) Body mass 1106-45921540). Robinson Ramírez-Vélez received a grant index, eating attitudes, and symptoms of depression from Instituto Colombiano para el Desarrollo de la Ciencia and anxiety in pregnancy and the postpartum period. y la Tecnología ‘Francisco José de Caldas’) to undertake a Psychosomatic Medicine 62: 264–270. doctorate (Grant Colciencias/Icetex No 067/2002). Chung TK, Lau TK, Yip AS, Chiu HF, Lee DT (2001) Antepartum Competing interests: The authors declare that they have no depressive symptomatology is associated with adverse competing interests. obstetric and neonatal outcomes. Psychosomatic Medicine 63: 830–834. Correspondence: Robinson Ramírez-Vélez, Medicine School, University of Valle, Calle 4B 36-00, Sede San Craft LL, Freund KM, Culpepper L, Perna FM (2007) Fernando, Cali, Colombia. Email: [email protected] Intervention study of exercise for depressive symptoms in women. Journal of Women’s Health 16: 1499–1509. 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Robledo-Colonia et al: Exercise during pregnancy and depression antenatal patients at two public hospitals in South Australia. Ramírez-Vélez R (2011a) Pregnancy and health-related quality Australian and New Zealand Journal of Obstetrics and of life: A cross sectional study. Colombia Medica 42: 476- Gynaecology 48: 248–254. 481. Hueston WJ, Kasik-Miller S (1998) Changes in functional Ramírez-Vélez R, Romero M, Echeverri I, Ortega JG, health status during normal pregnancy. Journal of Family Mosquera M, Salazar B, et al (2011b) A factorial randomized Practice 47: 209–212. controlled trial to evaluate the effect of micronutrients supplementation and regular aerobic exercise on maternal Jablensky AV, Morgan V, Zubrick SR, Bower C, Yellachich LA endothelium-dependent vasodilatation and oxidative stress (2005) Pregnancy, delivery, and neonatal complications in a of the newborn. Trials 12: 60. population cohort of women with schizophrenia and major affective disorders. American Journal of Psychiatry 162: Rethorst CD, Wipfli BM, Landers DM (2009) The antidepressive 79–91. effects of exercise: a meta-analysis of randomized trials. Sports Medicine 39: 491–511. Matthews MM, Hsu FC, Walkup MP, Barry LC, Patel KV, Blair SN (2011) Depressive symptoms and physical performance Shivakumar G, Brandon AR, Snell PG, Santiago-Munoz P, in the lifestyle interventions and independence for elders Johnson NL, Trivedi MH, et al (2011) Antenatal depression: pilot study. Journal of the American Geriatrics Society 59: a rationale for studying exercise. Depression and Anxiety 28: 495–500. 234–242. Montoya Arizabaleta AV, Orozco Buitrago L, Aguilar de Plata Watson JP, Elliot SA, Rugg AJ, Brough DI (1984) Psychiatric AC, Mosquera Escudero M, Ramírez-Vélez R (2010) Aerobic disorder in pregnancy and the first postnatal year. British exercise during pregnancy improves health-related quality of Journal of Psychiatry 144: 453–462. life: a randomised trial. Journal of Physiotherapy 56: 253– 258. Wells VE, Klerman GL, Deykin EY (1987) The prevalence of depressive symptoms in college students. Social Psychiatry Nakano Y, Oshima M, Sugiura-Ogasawara M, Aoki K, Kitamura and Psychiatric Epidemiology 22: 20–28. T, Furukawa TA (2004) Psychosocial predictors of successful delivery after unexplained recurrent spontaneous abortions: Yeo SA, Steele NM, Chang M-C, Leclaire SM, Roind DL, a cohort study. Acta Psychiatrica Scandinavica 109: 440– Hayashi R (2000) Effect of exercise on blood pressure in 446. pregnant women with a high risk of gestational hypertensive disorders. Journal of Reproductive Medicine 45: 293–298. Paluska SA, Schwenk TL (2000) Physical activity and mental health: current concepts. Sports Medicine 29: 167–180. Yonkers KA, Wisner KL, Stewart DE, Oberlander TF, Dell DL, Stotland N, et al (2009) The management of depression Radloff LS, Rae DS (1979) Susceptibility and precipitating during pregnancy: a report from the American Psychiatric factors in depression: sex differences and similarities. Association and the American College of Obstetricians and Journal of Abnormal Psychology 88: 174–181. Gynecologists. General Hospital Psychiatry 31: 403–413. Ramírez-Vélez R, Aguilar AC, Mosquera M, Garcia RG, Reyes LM, López-Jaramillo P (2009) Clinical trial to assess the effect of physical exercise on endothelial function and insulin resistance in pregnant women. Trials 10: 104. Journal of Physiotherapy 2012 Vol. 58 – © Australian Physiotherapy Association 2012. Open access under CC BY-NC-ND license. 15
Appraisal Critically Appraised Papers Bimanual therapy and constraint-induced movement therapy are equally effective in improving hand function in children with congenital hemiplegia Synopsis Summary of: Gordon AM et al (2011) Bimanual training and gross motor bimanual activities. Outcome measures: and constraint-induced movement therapy in children with The primary outcomes were the Jebsen-Taylor Test of Hand hemiplegic cerebral palsy: a randomized trial. Neurorehabil Function (JTTHF) to assess unimanual capacity and the Neural Repair 25: 692–702. [Prepared by Nora Shields, Assisting Hand Assessment (AHA) to assess bimanual CAP Editor.] performance. Secondary outcome measures were Goal Attainment Scale, Quality of Upper Extremity Skills Test Question: Does constraint-induced movement therapy (QUEST), and physical activity (percentage time each hand (CIMT) improve hand function in children with congenital was used during the AHA assessment). Assessments were hemiplegia compared to bimanual therapy? Design: completed before treatment, 2 days after treatment, and Randomised trial with concealed allocation and blinded 1 and 6 months after treatment. Results: 42 participants outcome assessment. Setting: 6 CIMT and bimanual completed the study. At the end of the 15-day intervention therapy day camps were conducted at a University in the period, the groups did not significantly differ on the primary United States. Participants: Children with congenital outcome measures and on two secondary outcome measures hemiplegia aged 3.5 to 10 years, with basic movement and (QUEST, physical activity). There were significant within grasp in their paretic hand, and who attended mainstream group changes for both groups on each primary outcome school. Health problems not associated with cerebral palsy, (mean change score JTTHF –137 s, 95% CI –174 to –99; severe hypertonia, and recent surgery or botulinum toxin mean change score AHA –0.49 logits, 95% CI 0.25 to therapy were exclusion criteria. Randomisation of 44 0.73) which were maintained at the 6 month follow-up. participants allocated 22 to the CIMT group and 22 to the There were also significant within group changes for both bimanual therapy group. The groups were matched for age groups for the QUEST and physical activity assessments. and hand function. Interventions: Both groups received 90 The bimanual therapy group made greater progress than hours of therapy, delivered in day-camps with 2–5 children the CIMT group on their Goal Attainment Scale scores in each group. Participants completed 6 hours of therapy a (mean difference between groups 8.1 T-score, 95% CI 0.7 day for 15 consecutive weekdays. Treatment was delivered to 15.5). Conclusion: CIMT and bimanual therapy resulted by physiotherapists, occupational therapists, and students in similar improvements in hand function among young enrolled in health related courses. Participants worked children with congenital hemiplegia. The bimanual therapy individually and in groups. The CIMT group had their group made better progress on established goals. less affected hand restrained in a sling and performed age appropriate fine and gross motor unimanual activities The [Mean difference between groups calculated by the bimanual therapy group engaged in age appropriate fine CAP Editor] Commentary through carefully tailored bimanual activities. Therefore, the choice of either approach will depend on a child’s Constraint induced movement therapy (CIMT) has individual goals, and consideration of behavioural aspects emerged as a promising upper limb rehabilitation approach (eg, tolerance of restraint). for children with congenital hemiplegia. Until recently, CIMT has been compared to control groups receiving The current study delivered 90 hours of therapy over a standard care or no treatment, raising questions whether three week period. While results of this well designed and improvements gained were a result of treatment methods rigorous study are positive, translation of such intensive or intensity of intervention (Sakzewski et al 2009). Gordon models of intervention into a real world clinical setting et al’s (2011) results suggest the latter and confirm similar is challenging. There remains limited data to suggest the findings (Facchin et al 2011, Sakzewski et al 2011) that optimum dosage required for either approach. What is either intensive treatment approach leads to sustained clear is that current standard practice probably does not improvement in upper limb function and achievement of offer sufficient intensity of intervention necessary to drive individualised goals. Both approaches are goal directed and sustained changes in upper limb function for children with provide intensive repetitive task practice using incremental congenital hemiplegia. challenges to drive changes in upper limb function. Leanne Sakzewski While results from either approach are similar, the Queensland Cerebral Palsy and Rehabilitation Research interventions are not the same. CIMT changes the role of the impaired hand. It becomes the dominant hand with Centre, The University of Queensland, Australia unimanual activities aimed to improve dexterity and efficiency of movement of that limb. It is assumed that gains References in unimanual abilities will translate to improved bimanual performance, a premise supported by results of this study. Facchin P et al (2011) Am J Phys Med Rehabil 90: 539–553. In bimanual training, the role of the impaired upper limb remains as the assisting hand with therapy aiming to Sakzewski L et al (2009) Pediatrics 123: e111–e1122. improve bimanual co-ordination and goal achievement Sakzewski L et al (2011) Dev Med Child Neurol 53: 313–320. Journal of Physiotherapy 2012 Vol. 58 – © Australian Physiotherapy Association 2012 59
Appraisal Critically Appraised Papers Eccentric hamstring muscle training can prevent hamstring injuries in soccer players Synopsis Summary of: Petersen J et al (2011) Preventive effect of from a kneeling position. Players completed 2–3 sets of eccentric training on acute hamstring injuries in men’s 5–12 repetitions of the exercise for 1–3 sessions per week. soccer: a cluster-randomized controlled trial. Am J Sports Outcome measures: The primary outcome was the number Med 39: 2296–2303. [Prepared by Nicholas Taylor, CAP of overall, new, and recurrent acute hamstring injuries Co-ordinator.] during one full soccer season. A hamstring injury was defined as any acute physical complaint in the region of the Question: Does eccentric muscle training of hamstring posterior thigh sustained during a soccer match or training. muscles reduce the rate of hamstring injuries in male Recurrence of an injury already reported in the trial period soccer players? Design: Cluster randomised, controlled was not included to avoid recording the same injury more trial with concealed allocation. Setting: The 5 top men’s than once. Results: 50 teams with 942 players completed the soccer divisions in Denmark. Participants: First team study. At the end of the season, there had been 15 hamstring squad soccer players from teams in the top 5 national soccer injuries (12 new, 3 recurrent) in the eccentric hamstring divisions were included. Players who joined a team after exercise group and 52 injuries (32 new, 20 recurrent) in the the start of the trial were excluded. Randomisation of 54 control group. The number needed to treat (NNT) to prevent teams allocated 26 to the intervention group and 28 to a 1 hamstring injury (new or recurrent) was 13 (95% CI 9 to control group. Interventions: Both groups followed their 23). The NNT to prevent 1 new injury was 25 (95% CI 15 usual training program. In addition, the intervention group to 72) and the NNT for recurrent injury was 3 (95% CI 2 completed 27 sessions of the eccentric hamstring muscle to 6). Apart from short term muscle soreness no adverse training in a 10-week period during the midseason break, events were reported in the exercise group. Conclusion: An and once a week in the second half of the season. The eccentric strengthening exercise program for the hamstring hamstring exercise (the Nordic curl) involves the player muscles that can be performed during training can help using hamstrings to resist forward falling of the trunk prevent hamstring injuries in soccer players. Commentary A minor criticism of this trial is that exposure time was not specifically quantified, which means that it cannot be stated It is well documented that acute hamstring muscle strain with certainty that there was no difference in the amount is the most common injury in many sports that involve of training and/or match participation between the control repeated bouts of sprinting, including soccer (Ekstrand and intervention groups. However, given the large numbers et al 2011) and Australian Rules football (Orchard and involved in this study and that professional versus amateur Seward 2011). Prevention of primary and recurrent injury players were evenly distributed between the groups, it is is therefore paramount, but unfortunately little evidence highly likely that any difference in exposure time was only currently exists to support the efficacy of preventive small (if present at all) and thus of no consequence to the interventions (Goldman and Jones 2011). reported outcomes. This rigorous large-scale trial is extremely relevant As acute hamstring muscle strain is likely a multifactorial for physiotherapists who treat sports people with acute injury, it is acknowledged that comprehensive preventive hamstring muscle strains, as it provides the strongest programs should be diverse but the fundamental components evidence yet that eccentric strength training can significantly of these programs must always comprise evidence-based reduce the incidence rate of both primary and especially interventions, such as the Nordic hamstring exercise. recurrent injury. The intervention was not complicated nor did it rely upon expensive gym-based equipment: repeated Anthony Schache sessions of the Nordic hamstring exercise were performed Department of Mechanical Engineering, The University of over a 10-week period, and the dosage prescribed produced a preventive effect for at least 12 months. While the Nordic Melbourne, Australia hamstring exercise might be considered an intense load, particularly for people who are unaccustomed to eccentric References strength training, it is important to note that no injuries were actually experienced during the conduct of the exercise Ekstrand J et al (2011) Am J Sports Med 39: 1226–1232. program. Thus, even though the intervention likely evoked considerable muscle soreness, it was safe. Goldman E, Jones D (2011) Physiother 97: 91–99. Orchard J, Seward H (2011) Sport Health 29: 15–29. 58 Journal of Physiotherapy 2012 Vol. 58 – © Australian Physiotherapy Association 2012
Kwah et al: Incidence and prediction of contractures post-stroke Half of the adults who present to hospital with stroke develop at least one contracture within six months: an observational study Li Khim Kwah1, Lisa A Harvey2, Joanna HL Diong1 and Robert D Herbert1 1The George Institute for Global Health, 2Rehabilitation Studies Unit, Sydney School of Medicine The University of Sydney, Australia Questions: What is the incidence of contractures six months after stroke? Can factors measured within four weeks of stroke predict the development of elbow, wrist, and ankle contractures six months later? Design: Prospective cohort study. Participants: Consecutive sample of 200 adults with stroke admitted to a Sydney hospital. Outcome measures: Loss of range of motion in major joints of the body was measured using a 4-point ordinal contracture scale. In addition, elbow extension, wrist extension, and ankle dorsiflexion range of motion were measured using torque-controlled procedures. Potential predictors of contracture were age, pre-morbid function, severity of stroke, muscle strength, spasticity, motor function, and pain. Measurements were obtained within four weeks of stroke and at six months after stroke. Results: 52% of participants developed at least one contracture. Incidence of contracture varied across joints from 12% to 28%; shoulders and hips were most commonly affected. Muscle strength was a significant predictor of elbow, wrist, and ankle joint range. Prediction models explained only 6% to 20% of variance in elbow, wrist, and ankle joint range. Conclusion: About half of all patients with stroke develop at least one contracture within six months of stroke. Incidence of contractures across all joints ranged from 12% to 28%. Muscle strength is a significant predictor of elbow, wrist, and ankle contractures but cannot be used to accurately predict contractures in these joints. <,XBI -, )BSWFZ -\" %JPOH +)- )FSCFSU 3% )BMG PG UIF BEVMUT XIP QSFTFOU UP IPTQJUBM XJUI TUSPLF EFWFMPQBUMFBTUPOFDPOUSBDUVSFXJUIJOTJYNPOUITBOPCTFSWBUJPOBMTUVEZJournal of Physiotherapy o> ,FZXPSET Contracture, Stroke, Incidence, Prognosis Introduction risk patients for intensive therapy and include high risk patients in future trials of interventions designed to prevent Contractures, or loss of passive joint range of motion contractures. Three longitudinal studies have reported that (Dudek and Trudel 2008), are common after stroke (Ada the development of elbow and wrist contractures could be and Canning 1990). Contractures can limit performance of predicted by baseline measures of weakness, spasticity and functional activities such as standing, walking, dressing, upper limb function (Ada et al 2006, Malhotra et al 2011, and grooming (Ada and Canning 1990, Dudek and Trudel Pandyan et al 2003). However these studies were small 2008, Fergusson et al 2007). They are also associated with (n ≤ 30 in all three studies), did not examine multivariate pain, pressure ulcers, falls, and other complications that predictors (Malhotra et al 2011, Pandyan et al 2003), increase dependence (Wagner and Clevenger 2010). Yet and considered few potential predictors (Ada et al 2006, there are few quantitative data on the proportion of patients Malhotra et al 2011, Pandyan et al 2003). who develop contractures, the location of contractures, or the characteristics of patients most susceptible to developing The research questions for this study were: contractures after stroke. 1. What is the incidence of contractures six months after stroke? Two prospective cohort studies have estimated the incidence 2. Can factors measured soon after stroke predict the of contractures one year after stroke. One reported an development of elbow, wrist, and ankle contractures? incidence of 23% (Pinedo and de la Villa 2001) whereas the other reported an incidence of 60% (Sackley et al 8IBUJTBMSFBEZLOPXOPOUIJTUPQJD Contractures 2008). One possible explanation for why these estimates are common after stroke. They can limit functional differ may be that one cohort consisted of patients recruited performance and cause complications such as pain, from a rehabilitation hospital (Pinedo and de la Villa 2001) pressure ulcers, and falls. and the other consisted of patients with a severe disabling stroke identified from a register (Sackley et al 2008). To 8IBUUIJTTUVEZBEET Within six months after stroke, our knowledge, no studies have documented the incidence about half of all patients develop a contracture. Muscle of contractures in the broader population of patients who strength is a significant predictor of elbow, wrist, and present to hospital with stroke. Such data are needed to ankle contractures but cannot be used to accurately quantify the magnitude of the problem of contractures after predict contractures in these joints. Simple clinical stroke. measures do not accurately predict who will develop a contracture. It would be useful to identify patients who are most susceptible to developing contractures. If that were possible, clinicians and researchers could target high Journal of Physiotherapy 2012 Vol. 58 – © Australian Physiotherapy Association 2012. Open access under CC BY-NC-ND license. 41
Research Method were more time consuming to collect, so they were obtained only for elbow extension, wrist extension, and Design ankle dorsiflexion. The procedures have been described in detail elsewhere (Harvey et al 1994, Moseley and Adams A prospective inception cohort study was conducted. 1991, Moseley et al 2008). The ankle dorsiflexion procedure Consecutive patients admitted to the accident and was modified slightly from the published description of the emergency department of St George Hospital (from January method (Moseley and Adams 1991). A spring balance and 2009 to January 2010) with a diagnosis of stroke or transient cuff were secured over the foot. The knee was extended. ischemic attack were screened. St George Hospital is a large Ankle dorsiflexion range was measured using a plurimeter teaching hospital that serves residents of southern Sydney, placed on the lateral aspect of the foot and the shank. Intra- Australia, and admits more than 500 patients a year with rater reliability of the elbow extension procedure (ICC = stroke and transient ischaemic attacks (SESIAHS 2010). 0.98, 95% CI 0.93 to 1.00) (Moseley et al 2008) and the Participants were followed up six months after stroke. wrist extension procedure (ICC = 0.71, 95% CI 0.38 to 1.00) (Harvey et al 1994) has been demonstrated. We tested the Participants inter-rater reliability for the modified ankle dorsiflexion procedure on a separate sample of 33 community-dwelling Patients were eligible for inclusion if they were over 18 years patients with multiple sclerosis, spinal cord injury, or stroke. old, had a medically documented stroke (WHO 1988), were Reliability was good (ICC = 0.86, 95% CI 0.81 to 0.92). A able to respond to basic commands, and understood English. participant was considered to have developed a contracture Patients who received recombinant tissue plasminogen if there was a minimum loss of 10 degrees between baseline activator were included if they had persisting neurological and final measurements. symptoms 24 hours after receiving treatment. Patients with subarachnoid haemorrhages were included only if they had The force applied during joint range measurements was neurological symptoms consistent with the WHO definition determined by what the therapists felt was end-range of of stroke (WHO 1988). Consent was sought from patients motion at a joint or by the force tolerated by the patient. or, where patients were unable to consent, from guardians. In the torque-controlled measurements, the force was All patients received standard medical and allied health quantified with the use of a spring balance and the same care. Although no attempt at standardisation was made, force was ensured for both baseline and final measures in care was generally administered in a way that was broadly each patient. consistent with the recommendation of the National Stroke Foundation guidelines (NSF 2010). Candidate predictors Outcome measures Candidate predictors were measured within four weeks of stroke. A total of nine candidate predictors were Three physiotherapists collected the data. Joint range considered. Pre-morbid function was measured using the of motion was measured as soon as possible (within four Barthel Index (Collin et al 1988, Kasner 2006). Severity weeks) and six months following stroke. All measurements of stroke was measured using the National Institutes of were performed with the participants either in supine or Health Stroke Scale (NIHSS) (Brott et al 1989, Kasner sitting. The following procedures were used. 2006). Muscle strength of elbow, wrist, and ankle flexors and extensors was assessed using the Manual Muscle Contracture scale: A 4-point ordinal scale was used to Testing scale (Hislop and Montgomery 2007, Kendall et measure joint range in all major upper and lower limb joints al 1993). Spasticity of elbow and wrist flexors and ankle of the body including the shoulders, elbows, forearms, plantarflexors was measured using the Tardieu Scale. wrists, fingers, thumbs, hips, knees, and ankles. Therapists Spasticity was considered to be present if a catch or clonus passively moved each joint through the available range of was observed during the fast-velocity component of the motion, assessing most planes of movement at each joint. As Tardieu scale (Patrick and Ada 2006). Motor function of it was necessary to measure a large number of joint ranges upper and lower limbs was measured using Item 4 (sitting in an acceptable period of time, a goniometer was not used. to standing), Item 5 (walking) and Items 6–8 (upper arm Range was scored as 0 (‘no loss in range of motion’), 1 (‘loss function, hand movements, advanced hand activities) of up to 1/3 range of motion’), 2 (‘loss of 1/3 to 2/3 range of of the Motor Assessment Scale (Carr et al 1985). Pain at motion’), or 3 (‘loss of greater than 2/3 range of motion’). the elbow, wrist and ankle was assessed using a vertical Therapists were instructed to categorise the loss of joint numerical rating scale (Leung et al 2007). The reliability of range in the patient with respect to joint range expected in these procedures had been demonstrated (Carr et al 1985, a person of similar age without contractures. Provided the Florence et al 1992, Kasner 2006, Lannin 2004, Leung et al contralateral side was not also impaired, the contralateral 2007, Mehrholz et al 2005). limb was used as a reference. Reliability was tested in a separate sample of 27 community-dwelling patients with Data analysis multiple sclerosis, spinal cord injury, or stroke. The inter- rater reliability was acceptable (Kendall’s tau statistic = Incidence proportions of any contracture and of contracture 0.62, bootstrapped 95% CI 0.49 to 0.74). A participant was in each joint were calculated for the whole cohort and for considered to have developed an incident contracture in the sub-cohort of patients with moderate to severe strokes a particular joint if there was an increase of one or more (NIHSS > 5). Confidence intervals were calculated using points on the contracture scale between baseline and final Newcombe’s method based on Wilson scores (Newcombe measures. 1998). For bilateral strokes, the side that performed worse at baseline was chosen for analysis; if both sides were the Torque-controlled measures: Torque-controlled measures same, one side was randomly selected. of range of motion were also obtained. These measures 42 Journal of Physiotherapy 2012 Vol. 58 – © Australian Physiotherapy Association 2012. Open access under CC BY-NC-ND license.
Kwah et al: Incidence and prediction of contractures post-stroke 5BCMF Characteristics of participants. Admitted to hospital Excluded (n = 356) Characteristics All Participants with stroke or transient Not medically participants available at ischaemic attack documented stroke (n = 200) follow-up (n = 573) (n = 262) (n = 165) Unable to respond Eligible (n = 217) to basic commands Age (yr), median (IQR) 78 (65 to 84) 77 (65 to 83) (n = 77) Recruited (n = 200) Unable to understand Gender, n females (%) 102 (51) 85 (52) English (n = 17) Followed up (n = 165) Thrombolysed, n (%) 19 (10) 16 (10) Did not participate (n = 17) Side of hemiplegia, n (%) Declined (n = 16) Moved to another right 94 (47) 75 (45) hospital (n = 1) left 89 (45) 74 (45) Lost to follow-up (n = 35) both 17 (8) 16 (10) Death (n = 23) Declined Type of stroke, n (%) assessment (n = 6) ischaemic 134 (67) 106 (64) Unable to contact intracerebral haemorrhage 42 (21) 38 (23) (n = 6) subarachnoid haemorrhage 7 (4) 8 (5) unknown 17 (8) 13 (8) Pre-morbid function (BI), n (%) ≤ 95 47 (24) 34 (21) 96 to 100 153 (76) 131 (79) Severity of stroke (NIHSS)a, n (%) mild (0 to 5) 107 (54) 94 (57) moderate (6 to 13) 59 (30) 49 (30) 'JHVSFFlow of participants through the study. severe (14 to 42) 33 (16) 22 (13) BI = Barthel Index, IQR = Inter-quartile range, NIHSS = National Institutes of Health Stroke Scale, a = NIHSS had one missing datum Regression analyses were conducted with the aim of intervals compared with conventional backwards stepwise identifying people who were most susceptible to developing selection of predictors (Austin 2008). Performance of the contractures. As there were very few missing data, only final models was evaluated with adjusted r2 values. patients with complete data sets of candidate predictors and joint range were considered in the statistical analysis. Results The dependent variables for these analyses were the torque- controlled measures of elbow extension, wrist extension, Flow of participants through the study and ankle dorsiflexion range of motion. Univariate linear regressions were carried out to determine the relationship The flow of participants through the study is shown in between predictors (measured within four weeks of stroke) Figure 1. Characteristics of participants are shown in Table and outcomes (measured at six months after stroke). All 1. Baseline measurements were taken at a median of 6 predictors except spasticity were treated as continuous days (IQR 3 to 11) after stroke. One hundred and sixty-five variables (Royston et al 2009). Spasticity was treated as a participants were followed up at a median of 6.1 months dichotomous variable. All predictors were entered into the (IQR 5.9 to 6.4) after stroke. initial model for multivariate analysis. The exception was predictors that were highly correlated (r > 0.6), in which Missing data case only the predictor that was easier to obtain in clinical practice was entered into the model. A bootstrap variable Follow-up data were not available from 35 participants: selection procedure was used that involved drawing 23 died and 12 declined to be re-assessed or could not 1000 samples from the original sample and carrying out be contacted. In addition, joint range measurements were backwards stepwise regression (with p value set at 0.2 to missing for a small number of participants (1 to 3) due to remove) in each bootstrap sample (Austin and Tu 2004). fractures and pain at the joints (Table 2). The development Predictors that were retained in 80% of the bootstrap samples of prediction models required complete data sets of both were selected for the final model. Regression coefficients outcomes and candidate predictors. For the prediction were zero-corrected to reduce bias (Austin 2008). Variable selection by bootstrapping has been shown to improve estimates of regression coefficients and their confidence Journal of Physiotherapy 2012 Vol. 58 – © Australian Physiotherapy Association 2012. Open access under CC BY-NC-ND license. 43
Research 5BCMF Incidence proportion of contractures by joint, as measured with the contracture scale and with torque-controlled procedures. All participants Moderate to severe strokes (NIHSS > 5) d%D % (95% CI) d%D % (95% CI) Contracture scale shoulder *'%',+ 25% (18 to 32) (-%-' 38% (26 to 50) elbow and forearm ),%',+ 22% (15 to 28) (+%-' 35% (24 to 47) wrist and hand ((%',* 13% (8 to 19) (&%-& 29% (18 to 39) hip *,%',+ 28% (21 to 35) (,%-' 37% (25 to 48) knee '/%',+ 12% (7 to 16) ')%-' 18% (9 to 28) ankle (*%',+ 15% (9 to 20) '.%-' 25% (15 to 36) Torque-controlled elbow extension (/%',) 18% (12 to 24) '/%,/ 28% (17 to 38) wrist extension (/%',( 18% (12 to 24) '-%,. 25% (14 to 36) ankle dorsiflexion '/%',* 12% (7 to 17) '*%-& 20% (10 to 30) n = number of participants who developed contracture, N = total number of participants analysis, data sets were incomplete for 10 participants Prediction of elbow, wrist and ankle contractures for elbow extension and ankle dorsiflexion and for 11 after stroke participants for wrist extension due to fractures, pain, poor compliance or inability to follow complex commands. Univariate analysis: Severity of stroke, muscle strength, and motor function were significantly associated (p < 0.05) Incidence of contractures after stroke with range of motion at six months (Table 3). However, only 1% to 17% of the variation in range of motion was explained Incidence proportions of contractures classified by joints are by these predictors. presented in Table 2. Incidence proportions of participants with at least one contracture are presented in Appendix 1 Multivariate analysis: As several of the candidate predictors of the eAddenda. In addition, we explored the incidence were highly correlated with each other, only five of the proportion of contractures defined in various ways in candidate predictors (age, pre-morbid function, strength, Appendices 1 to 3 of the eAddenda. spasticity, and pain) were entered into the multivariate analysis (Table 4). Muscle strength was the only predictor Contracture scale: Of 165 participants, 85 had an increase selected in more than 80% of bootstrap samples. Even in contracture scale score at one or more joints at six when all five predictors were forced into the model, they months. Thus 52% (95% CI 44 to 59) developed at least one only explained 6% to 20% of variation in contracture contracture. The incidence of contractures varied across development (adjusted r2 of full model for elbow extension joints from 12% to 28%. Shoulder and hip joints were = 0.19, wrist extension = 0.20, ankle dorsiflexion = 0.06). most commonly affected. In participants with moderate to severe strokes (NIHSS > 5), the incidence of contractures Discussion was higher. Of 71 participants with moderate to severe strokes, 47 (66%, 95% CI 55 to 76) developed at least one This study provides the first robust estimates of the incidence contracture. The incidence of contractures varied across of contractures in a representative sample of patients joints from 18% to 38% (Table 2). presenting to hospital with stroke. The data indicate that contractures are common; half the cohort (52%) developed Torque-controlled measures: Of 164 participants, 60 (37%; at least one contracture. Contractures are most common 95% CI 30 to 44) developed at least one contracture in the at the shoulder and hip, and more common in those with elbow, wrist, or ankle after stroke, according to the torque- moderate to severe strokes (NIHSS > 5). The data do not controlled measures. The incidence of contractures was 18% provide any further guidance on which patients are most (elbow extension), 18% (wrist extension), and 12% (ankle susceptible to contractures. It is widely believed that factors dorsiflexion) at six months after stroke. In patients with such as strength, pain, spasticity, and severity of stroke help moderate to severe strokes (NIHSS > 5) these estimates predict contractures yet in our models none of these factors increased to 28% (elbow extension), 25% (wrist extension), explain more than 20% of variation in range of motion at and 20% (ankle dorsiflexion). In participants with moderate six months. to severe strokes, 35 of 70 participants (50%; 95% CI 39 to 61) developed at least one contracture (Table 2). Few cohort studies have investigated the incidence of contractures after stroke (Fergusson et al 2007). Current estimates of the incidence proportion of contractures vary from 23% to 60% in the year after stroke (Pinedo and de la Villa 2001, Sackley et al 2008). Direct comparisons of our estimates to these studies are difficult due to the difference 44 Journal of Physiotherapy 2012 Vol. 58 – © Australian Physiotherapy Association 2012. Open access under CC BY-NC-ND license.
Kwah et al: Incidence and prediction of contractures post-stroke 5BCMF Univariate associations between candidate predictors and change in elbow extension, wrist extension and ankle dorsiflexion joint range. Elbow extension Wrist extension Ankle dorsiflexion Candidate predictors Coefficients r2 Coefficients r2 Coefficients r2 Age (95% CI) (95% CI) (95% CI) Pre-morbid function Severity of stroke –0.08 0.01 –0.02 0.00 –0.005 0.00 Muscle strength–flexors (–0.23 to 0.07) 0.03 (–0.20 to 0.16) 0.02 (–0.12 to 0.11) 0.01 Muscle strength–extensors 0.08 0.12 0.04 Motor function–combined upper arm 0.19 0.17 0.20 0.17 0.06 0.08 Motor function–sitting to standing (0.03 to 0.36)* 0.17 (–0.02 to 0.41) 0.17 (–0.06 to 0.19) 0.08 0.17 0.16 –0.66 –0.96 –0.36 – (–1.01 to –0.31)** – (–1.37 to –0.56)** – (–0.63 to –0.08)* 2.78 3.34 1.48 (1.80 to 3.77)** (2.17 to 4.52)** (0.66 to 2.30)** 2.85 3.28 1.58 (1.86 to 3.83)** (2.12 to 4.44)** (0.74 to 2.43)** 2.25 2.67 – (1.45 to 3.06)** (1.70 to 3.63)** 0.76 0.03 – – (0.09 to 1.43)* 0.01 0.04 Motor function–walking –– –– 0.48 (–0.28 to 1.23) 0.03 Spasticity –4.00 0.01 –7.53 0.01 –6.14 (–9.59 to 1.58) (–17.29 to 2.24) (–10.79 to Pain 0.54 0.00 1.15 0.00 –1.49)* *p < 0.05, **p < 0.01 (–1.62 to 2.70) (–2.54 to 4.84) –1.37 (–2.52 to –0.22)* 5BCMF Multivariate associations between candidate predictors and change in elbow extension, wrist extension and ankle dorsiflexion joint range. Candidate predictors Elbow extension Wrist extension Ankle dorsiflexion Age % Coefficient % Coefficient % Coefficients Pre-morbid function (95% CI) (95% CI) (95% CI) Muscle strength 36 – 31 – 34 – Spasticity Pain 51 – 71 – 33 – Constant 100 3.34 100 3.50 81 1.07 (1.67 to 5.67) (1.65 to 5.36) (0 to 2.24) 51 – 25 – 42 – 75 – 62 – 55 – 100 –23.85 100 –33.95 100 –4.10 (–80.94 to 6.48) (–89.09 to 2.45) (–24.68 to 14.13) % = % retained in bootstrap samples in characteristics of cohorts and lack of detailed information which is widely believed to predict contractures (Ada et al regarding measurement and definitions of contractures. 2006), was not a good predictor (it was selected in only 25% However, our estimates broadly align with those of earlier to 48% of bootstrap samples). This was despite the high studies. Our estimates may have been higher if we had incidence of spasticity at baseline (25 elbows, 11 wrists, 21 measured incidence of contractures at one year rather than ankles). Pain was arguably a better predictor than spasticity six months after stroke. (selected in a greater number of bootstrap samples than spasticity) even though few joints were painful (4 elbows, 2 It is not clear why we were not better able to predict wrists, 6 ankles). It is also possible that our failure to predict those susceptible to contractures. The predictors were contractures could have been due to errors associated chosen because they are believed to be associated with the with the measurement of either predictors or outcomes development of contractures. Interestingly, even spasticity, (contractures). However, the reliability of measurement Journal of Physiotherapy 2012 Vol. 58 – © Australian Physiotherapy Association 2012. Open access under CC BY-NC-ND license. 45
Research of all predictors used in the study had been demonstrated weakness and contracture of the elbow flexors and upper and the reliability of measures of joint range used in the limb activity after stroke: an observational study. Disability prediction analyses was high (ICC > 0.8). and Rehabilitation 28: 891−897. Our study had some limitations. First, there is little consensus Austin PC (2008) Using the bootstrap to improve estimation in the literature regarding definitions of contracture and confidence intervals for regression coefficients selected (Fergusson et al 2007). Our definitions of contracture were using backwards variable elimination. Statistics in Medicine chosen so that they could be applied easily to many joints, 27: 3286−3300. but they may not concur with other definitions of contracture or have functional implications. Choosing a definition of Austin PC, Tu JV (2004) Bootstrap methods for developing contracture that reflects a ‘functionally significant’ loss in predictive models. American Statistician 58: 131−137. joint range is difficult as this will vary across individuals and across joints. As some readers may wish that contracture National Stroke Foundation (2010) Clinical guidelines for stroke was defined differently, we have included more information cWdW][c[dj$ ^jjf0%%mmm$ijhea[\\ekdZWj_ed$Yec$Wk%Yb_d_YWb# on the incidence of contractures defined in various ways ]k_Z[b_d[iQ7YY[ii[Z(/I[fj[cX[h\"(&'&S in Appendices 1 to 3 of the eAddenda. Second, patients were recruited from only one site. As with any single-site Brott T, Adams HP, Olinger CP, Marler JR, Barsan WG, Biller study, the study sample may not be widely representative J, et al (1989) Measurements of acute cerebral infarction: a because of site idiosyncrasies. Last, a small proportion of clinical examination scale. Stroke 20: 864−870. data were missing, particularly from patients who were unable to be scored on the Motor Assessment Scale or the Carr JH, Shepherd RB, Nordholm L, Lynne D (1985) pain rating scale because of language deficits or impaired Investigation of a new motor assessment scale for stroke cognition. More viable measures of function and pain, eg, patients. Physical Therapy 65: 175−180. proxy measures of pain (Sackley et al 2008) or multiple imputation techniques (Sterne et al 2009), could be used to Collin C, Wade DT, Davies S, Horne V (1988) The Barthel ADL reduce the potential bias caused by missing data in future Index: a reliability study. International Disability Studies 10: studies. 61−63. In conclusion, about half of all patients developed at least Dudek N, Trudel G (2008) Joint contractures. In Frontera W, one contracture after stroke. Incidence of contractures Silver J, Rizzo T (Eds) Essentials of Physical Medicine across all joints ranged from 12% to 28% six months and Rehabilitation Musculoskeletal Disorders, Pain, after stroke. A range of simple clinical measures do not and Rehabilitation (2nd edn). Philadelphia: Saunders pp accurately predict who will develop a contracture. Q 651−655. eAddenda: Appendices 1, 2, and 3 available at jop. Fergusson D, Hutton B, Drodge A (2007) The epidemiology physiotherapy.asn.au of major joint contractures – a systematic review of the literature. Clinical Orthopaedics and Related Research 456: Ethics: The local Human Research Ethics committee 22−29. (South Eastern Sydney and Illawarra Area Health Service) approved this study. All participants or guardians gave Florence JM, Pandya S, King WM, Robison JD, Baty J, Miller written informed consent before data collection began. JP, et al (1992) Intrarater reliability of manual muscle test (Medical Research Council scale) grades in Duchenne’s Competing interests: None. muscular dystrophy. Physical Therapy 72: 115−122. Support: The project was supported by the Physiotherapy Harvey L, King M, Herbert R (1994) Test-retest reliability of a Research Foundation, and by the Neurology Department of procedure for measuring extensibility of the extrinsic finger St George Hospital. Professor Herbert is supported by the flexor muscles. Journal of Hand Therapy 7: 251−254. Australian NHMRC. Hislop H, Montgomery J (2007) Daniels and Worthingham’s Acknowledgements: The authors thank patients and family Muscle Testing: Techniques of Manual Examination (8th members who were part of the study. The authors also edn). St Louis: Saunders. thank the assistance of Li Na Goh and Min Jiat Teng who worked as research assistants on the project. Kasner SE (2006) Clinical interpretation and use of stroke scales. Lancet Neurology 5: 603−612. Correspondence: Professor Rob Herbert, Musculoskeletal Division, The George Institute for Global Health, University Kendall F, McCreary E, Provance P (1993) Muscles Testing of Sydney, Australia. Email: [email protected]. and Function (4th edn). Baltimore, Maryland: Williams and au Wilkins. References Lannin N (2004) Reliability, validity and factor structure of the upper limb subscale of the Motor Assessment Scale (UL- Ada L, Canning C (1990) Anticipating and avoiding muscle MAS) in adults following stroke. Disability and Rehabilitation shortening. In Ada L, Canning C (Eds) Key issues in 26: 109−116. neurological physiotherapy. Oxford: Butterworth Heinemann, pp 219−236. Leung J, Moseley A, Fereday S, Jones T, Fairbairn T, Wyndham S (2007) The prevalence and characteristics of shoulder Ada L, O’Dwyer N, O’Neill E (2006) Relation between spasticity, pain after traumatic brain injury. Clinical Rehabilitation 21: 171−181. Malhotra S, Pandyan AD, Rosewilliam S, Roffe C, Hermens H (2011) Spasticity and contractures at the wrist after stroke: time course of development and their association with functional recovery of the upper limb. Clinical Rehabilitation 25: 184−191. Mehrholz J, Wagner K, Meissner D, Grundmann K, Zange C, Koch R, Pohl M (2005) Reliability of the Modified Tardieu Scale and the Modified Ashworth Scale in adult patients with severe brain injury: a comparison study. Clinical Rehabilitation 19: 751−759. Moseley A, Adams R (1991) Measurement of passive ankle dorsiflexion: procedure and reliability. Australian Journal of Physiotherapy 37: 175−181. Moseley AM, Hassett LM, Leung J, Clare JS, Herbert RD, 46 Journal of Physiotherapy 2012 Vol. 58 – © Australian Physiotherapy Association 2012. Open access under CC BY-NC-ND license.
Kwah et al: Incidence and prediction of contractures post-stroke Harvey LA (2008) Serial casting versus positioning for the Sackley C, Brittle N, Patel S, Ellins J, Scott M, Wright C, Dewey treatment of elbow contractures in adults with traumatic brain ME (2008) The prevalence of joint contractures, pressure injury: a randomized controlled trial. Clinical Rehabilitation sores, painful shoulder, other pain, falls, and depression 22: 406−417. in the year after a severely disabling stroke. Stroke 39: 3329−3334. National Stroke Foundation (2010) Clinical guidelines for stroke cWdW][c[dj$ ^jjf0%%mmm$ijhea[\\ekdZWj_ed$Yec$Wk%Yb_d_YWb# Iekj^;Wij[hdIoZd[o ?bbWmWhhW7h[W>[Wbj^I[hl_Y[ (&'& ]k_Z[b_d[iQ7YY[ii[Z(/I[fj[cX[h(&'&S Brushing up on the signs of stroke can save your life. ^jjf0%%mmm$i[i_W^i$^[Wbj^$dim$]el$Wk%d[miUWdZU[l[dji Newcombe RG (1998) Two-sided confidence intervals for the %(&'&%(&'&&/'&U8hki^_d]Kf$Wif Q7YY[ii[Z (& :[Y[cX[h\" single proportion: comparison of seven methods. Statistics (&'&S in Medicine 17: 857−872. Sterne JA, White IR, Carlin JB, Spratt M, Royston P, Kenward Pandyan AD, Cameron M, Powell J, Stott DJ, Granat MH MG, et al (2009) Multiple imputation for missing data in (2003) Contractures in the post-stroke wrist: a pilot study of epidemiological and clinical research: potential and pitfalls. its time course of development and its association with upper BMJ (Clinical Research Ed.) 338: b2393. limb recovery. Clinical Rehabilitation 17: 88−95. Wagner LM, Clevenger C (2010) Contractures in nursing Patrick E, Ada L (2006) The Tardieu Scale differentiates home residents. Journal of the American Medical Directors contracture from spasticity whereas the Ashworth Scale is Association 11: 94−99. confounded by it. Clinical Rehabilitation 20: 173−182. WHO MPPI (1988) The World Health Organization MONICA F_d[Ze I\" Z[ bW L_bbW <C (&&' Q9ecfb_YWj_edi _d j^[ Project (Monitoring trends and determinants in cardiovascular ^[c_fb[]_Y fWj_[dj _d j^[ Åhij o[Wh W\\j[h j^[ ijhea[S$ Revista disease): a major international collaboration. Journal of de Neurologia 32: 206−209. Clinical Epidemiology 41: 105−114. Royston P, Moons KG, Altman DG, Vergouwe Y (2009) Prognosis and prognostic research: Developing a prognostic model. BMJ (Clinical Research Ed.) 338: b604. Statement regarding registration of clinical trials from the Editorial Board of Journal of Physiotherapy All clinical trials submitted to Journal of Physiotherapy for publication must have been registered in a publicly-accessible trials register. We will accept any register that satisfies the International Committee of Medical Journal Editors requirements. Authors must provide the name and address of the register and the trial registration number on submission. Trials that have been registered prospectively will be given higher priority. From 2013 the journal will only accept trials that have been registered prospectively unless data collection began before 2006, in which case retrospective registration is acceptable. Journal of Physiotherapy 2012 Vol. 58 – © Australian Physiotherapy Association 2012. Open access under CC BY-NC-ND license. 47
Appraisal Correspondence Likelihood ratios ought to be interpreted in the context of the pre-test odds I read with interest the paper by Prosser et al (2011) which So you’re now saying it’s a ‘good’ test then? Well, no. nicely documented the likelihood ratios (LRs) associated With the same example, but pre-test odds of 10%, we have with wrist examination. I question the application of the post-test odds of 38% and 2% respectively for positive and descriptors associated with the results, and feel that a central negative tests – ie, despite the test outcome I still think message of this paper could be read as ‘none of these tests the patient probably doesn’t have the pathology. 90% pre- are much use’. I believe this is a misrepresentation. test odds would be associated with post-test odds of 98% and 64%, ie, I still think that they probably do have this Clinicians want to know if, after doing some test, the pathology, I’m just betting different amounts of money on patient is more or less likely to have some pathology, and it. Claiming these tests are ‘good’ or ‘bad’ because of their by how much. The LR allows the clinician, by Bayesian LR is misleading since their clinical interpretation relies reasoning, to arrive at the odds that some pathology is equally on the pre-test odds (except for LRs of 1 which are present after knowing both the result of the test and the genuinely useless as they don’t alter the post-test odds at pre-test odds (Altman and Bland 1994). There’s evidence a all.) Beyond that, we can only really use these LR numbers lot of clinicians don’t really understand this concept fully in isolation to compare the utility of two different tests, ie, (Westover et al 2011) so we need to be careful in presenting ‘how much better is this test than that test?’ Stating that the data that can confuse this issue. I’m arguing that adding the test is of ‘limited’ or ‘moderate’ utility without reference descriptors ‘limited’ and ‘moderate’ (Prosser et al 2011) is to the pre-test odds is essentially trying to describe if some not useful as a LR is no use to a clinician with a patient in number (which can range from 0 to 1, or 1 to infinity, front of them unless you also know the associated pre-test Altman and Bland 1994) is ‘large’ or ‘small’. This paper odds for that pathology. If you instead only rely on these has documented (very well in my opinion) LR for these descriptors, then it’s an easy step for the unwary clinician clinical tests, and I think this is how the data should have to think ‘this test is not worth doing’ since Prosser and been presented. colleagues said its use was ‘limited’ (Prosser et al 2011). Rod Whiteley Say, based on the history, a patient has pre-test odds of 50% of having a tear in their TFCC, ie, an even money Physiotherapy Department, Aspetar Orthopaedic and Sports Medicine bet. Positive and negative MRI findings are associated with Hospital, Qatar LRs of about 5.6 and 0.2 respectively (Prosser et al 2011) which means that the clinician would then be able to say, References ‘after doing the test, the odds will be either 84% or 17% that the patient has the pathology.’ The physio can then tell Prosser R, et al (2011) J Physiother 57: 247–253. her patient if the MRI is positive that there are ‘more than 4 chances in 5 of having a TFCC tear’ or (after a negative test) Altman DG, Bland JM (1994) BMJ 309: 102. ‘less than 2 chances in 5 of a tear’. She has gone from a coin toss to being right about 80% of the time, and if the patient Westover MB, et al (2011) BMC Med 9: 20. wants to know if they should see a surgeon or not, she can now help them make their decision. 66 Journal of Physiotherapy 2012 Vol. 58 – © Australian Physiotherapy Association 2012
Nee et al: Neural tissue management for neck and arm pain Neural tissue management provides immediate clinically relevant benefits without harmful effects for patients with nerve-related neck and arm pain: a randomised trial Robert J Nee1, Bill Vicenzino1, Gwendolen A Jull1, Joshua A Cleland2 and Michel W Coppieters1 1Division of Physiotherapy, School of Health and Rehabilitation Sciences, The University of Queensland, Australia, 2Department of Physical Therapy, College of Graduate and Professional Studies, Franklin Pierce University, USA Question: What are the benefits and harms of neural tissue management in the short term for treating nerve-related neck and arm pain? Design: Randomised controlled trial. Participants: Sixty participants with non-traumatic nerve-related neck and unilateral arm pain were randomised to experimental (n = 40) or control (n = 20) groups. Intervention: Both groups were advised to continue usual activities. The experimental group also received education, manual therapy, and nerve gliding exercises in 4 treatments over 2 weeks. Outcome measures: Primary outcomes were participant-reported improvement and worsening on a Global Rating of Change scale. Secondary outcomes were neck pain, arm pain, the Neck Disability Index, the Patient-Specific Functional Scale, and adverse events related to treatment. Follow-up occurred 3–4 weeks after baseline. Results: Numbers needed to treat favoured the experimental intervention for participant-reported improvement (2.7, 95% CI 1.7 to 6.5), neck pain (3.6, 95% CI 2.1 to 10), arm pain (3.6, 95% CI 2.1 to 10), Neck Disability Index (4.3, 95% CI 2.4 to 18.2), and Patient-Specific Functional Scale (3.0, 95% CI 1.9 to 6.7). The prevalence of worsening in the experimental (13%) and control (20%) groups were not different (RD –7%, 95% CI –28 to 13). Adverse events had minimal impact on daily activities and did not reduce the chance of improving with the experimental intervention (RR = 1.03, 95% CI 0.58 to 1.84). Conclusion: These results enable physiotherapists to inform patients that neural tissue management provides immediate clinically relevant benefits beyond advice to remain active with no evidence of harmful effects. Trial registration: ACTRN 12610000446066. </FF 3+ 7JDFO[JOP # +VMM (\" $MFMBOE +\" $PQQJFUFST .8 /FVSBM UJTTVF NBOBHFNFOU QSPWJEFT JNNFEJBUF DMJOJDBMMZSFMFWBOUCFOFmUTXJUIPVUIBSNGVMFGGFDUTGPSQBUJFOUTXJUIOFSWFSFMBUFEOFDLBOEBSNQBJOBSBOEPNJTFE USJBMJournal of Physiotherapyo> Key words: Spinal nerves, Upper limb neurodynamic test, Manual therapy, Nerve gliding, Neurodynamic treatment Introduction history of nerve-related neck and arm pain. Allison et al (2002) conducted the only randomised controlled trial that One month prevalence rates for activity-limiting neck addressed this question. Although within-group analyses pain range from 7.5% to 14.5% in the general population showed significant changes in pain and function for the (Hogg-Johnson et al 2008, Webb et al 2003). Neck pain treatment group but not the control group, the lack of a spreading down the arm is more common than neck pain between-group analysis meant that no conclusive statement alone and is associated with higher levels of self-reported could be made about the effects of neural tissue management disability (Daffner et al 2003). One mechanism for neck (Boutron et al 2010). However, Gross et al (2004) conducted pain spreading down the arm is the sensitisation of neural a between-group analysis on these data in their systematic tissues (Bogduk 2009). review. Standardised mean differences favoured neural tissue management over no intervention for improving pain Evidence on the benefits and harms of physiotherapy and function but were not statistically significant. Low interventions for nerve-related neck and arm pain is needed statistical power related to the small sample (treatment = (Carlesso et al 2010a, Miller et al 2010). Neural tissue 17, control = 10) may explain these non-significant results. management is one physiotherapy intervention advocated A randomised controlled trial with a larger sample is for nerve-related neck and arm pain (Butler 2000, Childs needed to determine whether neural tissue management can et al 2008, Elvey 1986). Neural tissue management uses specific positions and movements of the neck and arm to 8IBUJTBMSFBEZLOPXOPOUIJTUPQJD Neck pain reduce nerve mechanosensitivity, resolve symptoms, and spreading down the arm is common and disabling. restore function (Butler 2000, Coppieters and Butler 2008, Elvey 1986). Physiotherapists have been advised to apply 8IBUUIJTTUVEZBEET Four sessions of neural tissue neural tissue management carefully to minimise the chance management over two weeks increased the number of that treatment will aggravate sensitised neural tissues people who experienced substantial reductions in neck (Butler 2000, Elvey 1986, Hall and Elvey 2004). pain, arm pain, and self-reported activity limitations. Adverse events such as aggravation of pain or Despite it being a recommended intervention (Childs et al headache were typically brief, non-disabling, and were 2008), it is unclear whether a multi-session neural tissue not associated with poorer outcomes at four weeks. management program can change the short-term natural Journal of Physiotherapy 2012 Vol. 58 – © Australian Physiotherapy Association 2012. Open access under CC BY-NC-ND license. 23
Research change the short-term natural history of nerve-related neck (Butler 2000, Elvey 1997). This ULNT1MEDIAN response and arm pain. Additionally, as with other physiotherapy suggested that participants’ symptoms were at least partly interventions for the cervical spine, detailed information related to increased nerve mechanosensitivity (Butler about adverse events related to neural tissue management is 2000, Hall and Elvey 2004). Participants with two or more needed (Carlesso et al 2010a). abnormal neurological findings (decreased strength, reflex, or sensation) at the same nerve root level (C5 to T1) were Thus, the research questions for this study were: excluded. It has been suggested that these two enrolment 1. For patients with nerve-related neck and arm pain, criteria would select participants who would be considered what are the benefits and harms of neural tissue appropriate candidates for neural tissue management management compared to advice to remain active in (Butler 2000, Elvey 1986, Hall and Elvey 2004). the short term? 2. What are the characteristics (type, frequency, onset, Additional exclusion criteria were: bilateral arm symptoms, duration, severity) of any adverse events that patients symptoms or signs suggestive of cervical myelopathy, relate to neural tissue management? physiotherapy intervention for neck and arm pain within 3. Does experiencing an adverse event reduce a patient’s the previous six weeks, previous neck or upper limb chance of benefitting from neural tissue management? surgery, and medical red flags (Childs et al 2004) that suggested serious pathology. Self-report outcomes required Method that participants were proficient in speaking and reading English. Consecutive participants who met all enrolment Design criteria and provided informed consent entered the trial. A randomised controlled trial was conducted. A detailed Physiotherapists (n = 8) who provided neural tissue protocol has been published elsewhere (Nee et al 2011). management had postgraduate qualifications in Participants were randomised to receive advice to remain musculoskeletal physiotherapy and attended a two-hour active and neural tissue management (experimental group) or training session prior to initiating the trial. Physiotherapists advice to remain active only (control group). The Queensland were located at eight private physiotherapy practices Clinical Trials Centre prepared the randomisation list with in the local metropolitan area. Participants assigned to a random number generator. Randomisation occurred the experimental group received treatment at the most in blocks of 12 without stratification. Participants were convenient location. assigned to the experimental or control group in a 2:1 ratio to increase the data available for a separate analysis to develop Intervention a model that predicts the likelihood of improvement with neural tissue management (Nee et al 2011). Allocation was All participants were advised to continue their usual concealed. Group assignments were sealed in sequentially activities after the baseline assessment. Baseline numbered, opaque envelopes by a research assistant who medication use was documented and participants were was not involved in data collection. Another independent allowed to continue use of over-the-counter or prescription research assistant revealed the group assignment to each medications for their symptoms as needed or as instructed participant after the baseline assessment. Neural tissue by their medical practitioner. management involved a standardised program of four treatments over two weeks. Outcomes were measured Neural tissue management was based on principles proposed at baseline and at a follow-up four weeks later. Adverse by Elvey (1986) and Butler (2000). Along with advice to events that participants related to neural tissue management continue their usual activities, participants assigned to the were documented with a questionnaire administered at the experimental group received an educational component, second through fourth treatments and at follow-up. Baseline manual therapy techniques, and a home program of nerve and follow-up data were collected at a research laboratory gliding exercises. The educational component attempted to within a tertiary academic institution. The examiner who reduce unnecessary apprehension participants may have collected baseline and follow-up data was blinded to group had about neural tissue management (Butler 2000). The assignments. It was not possible to blind participants or the manual therapy techniques and nerve gliding exercises physiotherapists who provided interventions. have been advocated for reducing nerve mechanosensitivity (Butler 2000, Coppieters and Butler 2008, Elvey 1986). Participants, therapists, centres The educational component emphasised two points. First, Participants were recruited from the general community examination findings suggested that participants’ symptoms through advertisements in local newspapers and electronic were at least partly related to nerves in the neck and arm newsletters. Eligible participants were aged 18–60 years that had become overly sensitive to movement. Second, with non-traumatic neck and unilateral arm pain that neural tissue management techniques would move the spread below the deltoid tuberosity. Symptoms had to have nerves in a gentle and pain-free manner, aiming to reduce been present for at least four weeks and preceded by a pain- this sensitivity. The manual therapy techniques included free period of four weeks or longer (de Vet et al 2002). a contralateral cervical lateral glide and a shoulder girdle Participants’ average levels of neck and arm pain during the oscillation combined with active craniocervical flexion to previous week were recorded on separate 11-point numeric elongate the posterior cervical spine (Elvey 1986). The home pain rating scales (Jensen et al 1994). The mean of these program of nerve gliding exercises involved a ‘sliding’ and two scores had to be ≥ 3/10 for participants to enter the trial. a ‘tensioning’ technique for the median nerve and cervical nerve roots (Coppieters and Butler 2008). In the ‘sliding’ Participants’ symptoms had to be reproduced by the technique, a movement that lengthened the median nerve upper limb neurodynamic test for the median nerve bed (elbow and wrist extension) was counterbalanced by a (ULNT1MEDIAN) and changed by structural differentiation movement that shortened the nerve bed (neck lateral flexion (contralateral neck sidebending or releasing wrist extension) 24 Journal of Physiotherapy 2012 Vol. 58 – © Australian Physiotherapy Association 2012. Open access under CC BY-NC-ND license.
Nee et al: Neural tissue management for neck and arm pain or rotation toward the symptomatic arm). The ‘tensioning’ pain during the previous 24 hours (Cleland et al 2008). technique only used movements that lengthened the Participant-reported activity limitations were measured by median nerve bed (elbow and wrist extension alone or the Neck Disability Index (Vernon and Moir 1991) and the combined with neck lateral flexion or rotation away from Patient-Specific Functional Scale (Westaway et al 1998). the symptomatic arm). Shoulder abduction angles up to 90 degrees were used to preload the neural tissues during The Global Rating of Change was also the primary manual therapy techniques and nerve gliding exercises. outcome for harms related to neural tissue management. Neural tissue management techniques were prescribed to Participants with a change ≤ –2 (at least ‘a little worse’) at not provoke participants’ symptoms. A gentle stretching follow-up were classified as ‘worse’. Secondary outcomes or pulling sensation that settled immediately after the included the number of participants who stopped neural technique was the maximum sensory response allowed. tissue management early because they developed two or Detailed protocols for applying neural tissue management more abnormal neurological signs during an exacerbation techniques have been described previously (Nee et al 2011). that they and the physiotherapist related to neural tissue management and adverse events that participants related to To verify that neural tissue management did not worsen neural tissue management. a participant’s condition, physiotherapists monitored the body diagram, the mean numeric pain rating score for An adverse event was defined as aggravation of existing current, highest, and lowest levels of arm pain during the symptoms or provocation of other unpleasant sensations previous 24 hours (Cleland et al 2008), and the Patient- after each neural tissue management treatment session Specific Functional Scale (Westaway et al 1998) at the (Carlesso et al 2010b, Hurwitz et al 2004). Participants start of each treatment. Any indication that a participant’s described the characteristics (type, onset, duration, severity) condition may have worsened (new report of numbness of each adverse event on a questionnaire administered at the or tingling, ≥ 1 point increase in arm pain, or ≥ 1 point second through fourth treatments and at follow-up. decrease in average Patient-Specific Functional Scale score) required the physiotherapist to recheck strength, Data analysis reflexes, and sensation to make sure the participant did not have two or more abnormal neurological findings. The The difference in prevalence of ‘improvement’ (Global physiotherapist and participant discussed and documented Rating of Change ≥ +4) and ‘worsening’ (Global Rating of whether they felt any exacerbation was related to neural Change ≤ –2) between the experimental and control groups tissue management or to some other change in activity level. were the primary analyses for the benefits and harms Neural tissue management was stopped if an exacerbation of the intervention. ‘Worst case’ intention-to-treat and occurred that was associated with the development of two ‘complete case’ analyses were performed (Moher et al 2010, or more abnormal neurological findings. The participant Sterne et al 2009). In the ‘worst case’ analysis for benefit, was monitored after the follow-up assessment and referred participants who did not return for follow-up were classified for medical management as necessary. Data were retained as ‘not improved’ if assigned to the experimental group and for statistical analysis in accordance with intention-to-treat ‘improved’ if assigned to control. For harm, participants principles (Moher et al 2010). who did not return for follow-up were classified as ‘worse’ if assigned to the experimental group and ‘not worse’ if Participants assigned to the control group received only assigned to control. ‘Complete case’ analyses included only advice to continue their usual activities. This provided a participants who completed follow-up. The risk difference measure of the natural history of nerve-related neck and (RD) and 95% CI quantified the size of any difference in arm pain. To encourage these participants to remain in the prevalence of improvement or worsening between the study for the 4-week control period without treatment, they groups. When the 95% CI for a RD did not contain zero, were advised that they would receive treatment afterwards, the point estimate for the beneficial or harmful effect was as shown in Figure 1. After the trial, they received reported as a number needed to treat (NNT) or number four complimentary treatments from one of the trial’s needed to harm (NNH) with a 95% CI. physiotherapists. Interventions were at the physiotherapists’ discretion and no data were collected. Differences between groups in follow-up scores for neck pain, arm pain, Neck Disability Index, and Patient-Specific Outcome measures Functional Scale were the secondary analyses for the benefits of neural tissue management. Neck pain, arm pain, The primary outcome for the benefits of neural tissue and Neck Disability Index were analysed with separate management was participant-reported improvement on a analyses of covariance (ANCOVA). Follow-up scores in 15-point Global Rating of Change scale. The scale spans each ANCOVA were adjusted by using the baseline score as from –7 (‘a very great deal worse’) to 0 (‘no change’) to +7 the covariate (Vickers and Altman 2001). Because Patient- (‘a very great deal better’) (Jaeschke et al 1989). Participants Specific Functional Scale activities were different for each who reported a change ≥ +4 (at least ‘moderately better’) at participant, these change scores were analysed with an follow-up were classified as ‘improved’. This represents at unpaired t-test. The size of any treatment effect was reported least moderate improvement in the participant’s condition as the difference between group means and a standardised (Jaeschke et al 1989). mean difference, each with a 95% CI. The latter allowed a comparison to previously reported treatment effects of Secondary outcomes for the benefits of neural tissue neural tissue management (Gross et al 2004). To further aid management were improvements in impairments in the interpretation of any treatment effects related to these neck and arm pain intensity and reduced participant- secondary outcomes (Dworkin et al 2009), NNTs with 95% reported activity limitations. Neck and arm pain intensity CIs were calculated for the number of participants who were measured by mean numeric pain rating scores for achieved clinically important change scores for neck and the participant’s current, highest, and lowest levels of arm pain (≥ 2.2 points) (Young et al 2010), Neck Disability Journal of Physiotherapy 2012 Vol. 58 – © Australian Physiotherapy Association 2012. Open access under CC BY-NC-ND license. 25
Research Volunteers who responded to recruitment advertisements screened for nerve-related neck and unilateral arm pain (n = 587) Excluded (n = 527) unable to contact (n = 58) no clinic locations convenient (n = 41) age > 60 yr (n = 37) traumatic consent (n = 6) location of symptoms (n = 157) Yecfei_j[fW_dhWj_d]2)%'& d3*. physiotherapy in previous 6 wk (n = 58) previous neck or upper limb surgery (n = 21) negative median nerve neurodynamic test (n = 83) • ≥ 2 abnormal neurological signs (n = 3) decided not to participate (n = 13) not fluent in English (n = 1) congenital hand deformity in uninvolved limb prevented bilateral comparison (n = 1) Week 0 Measured neck and arm pain intensity over previous 24 hr and participant-reported activity limitations with Neck Disability Index and Patient-Specific Functional Scale Randomised in 2:1 ratio (n = 60) (n = 40) (n = 20) Lost to follow-up Experimental Group Control Group Lost to follow-up (n = 2) advice to remain active advice to remain active (n = 2) brief education changed work manual therapy no reason given schedule prevented nerve gliding exercises (n = 1) attendance at 4 treatments over 2 wk treatments with hospitalised for neural tissue an unrelated management and medical issue participant decided (n = 1) not to attend follow- up (n = 2) Week 4 Measured participant-reported improvement or worsening with the Global Rating of Change scale, neck and arm pain intensity over the previous 24 hr, and participant- reported activity limitations with Neck Disability Index and Patient-Specific Functional Scale (n = 38) (n = 18) Participation in study completed Received 4 physiotherapy treatments (Physiotherapist determined intervention) 'JHVSF Design and flow of participants through the trial. 26 Journal of Physiotherapy 2012 Vol. 58 – © Australian Physiotherapy Association 2012. Open access under CC BY-NC-ND license.
Nee et al: Neural tissue management for neck and arm pain 5BCMF Baseline characteristics of participants. Characteristic All Exp Con (n = 60) (n = 40) (n = 20) Gender, n female (%) 38 (63) 26 (65) 12 (60) Age (yr), mean (SD) 47 (9) 47 (8) 48 (9) Body Mass Index (kg/m2), mean (SD) 26.7 (4.4) 27.3 (4.7) 25.7 (3.7) Duration of symptoms (wk), median (IQR) 26 (12 to 77) 32 (15 to 104) 18 (8 to 39) Symptoms distal to elbow, n (%) 46 (77) 29 (73) 17 (85) Arm symptoms worst, n (%) 20 (33) 11 (28) 9 (45) Reported numbness or tingling, n (%) 32 (53) 20 (50) 12 (60) Using medication for symptoms, n (%) 27 (45) 23 (58) 4 (20) Neck pain previous 24 hrs (0 to 10), mean (SD) 4.2 (2.0) 4.3 (1.7) 4.1 (2.4) Arm pain previous 24 hrs (0 to 10), mean (SD) 4.0 (1.6) 4.0 (1.6) 4.1 (1.6) Neck Disability Index (0 to 50), mean (SD) 12.5 (4.4) 12.7 (4.2) 12.1 (4.7) Exp = experimental (neural tissue management), Con = control (advice to remain active) Index (≥ 7 points, 0 to 50 scale) (MacDermid et al 2009), Compliance with the trial method and Patient-Specific Functional Scale (≥ 2.2 points) (Cleland et al 2006, Young et al 2010). Follow-up visits for some participants occurred at three weeks rather than four, but there was no significant The characteristics of adverse events related to neural difference in the time from baseline to follow-up between tissue management were reported with descriptive the experimental (mean 24 days, SD 4) and control (mean 25 statistics. A risk ratio (RR) with a 95% CI was calculated to days, SD 2) groups. All participants who completed follow- determine whether experiencing an adverse event reduced a participant’s chance for being improved at follow-up. Only ‘Im proved’ 7 5 (13) 1 (6) ‘complete case’ analyses were performed on secondary 6 3 (8) 1 (6) outcomes for the benefits and harms of neural tissue Global Rating of Change 5 7 (18) 1 (6) management. ‘Worse’ 4 6 (16) 7 (39) 3 2 (5) 4 (22) The sample size was based on having 80% power to detect a 2 4 (11) 33% difference in the prevalence of ‘improvement’ between 1 7 (18) 2 (11) groups (p ≤ 0.05). This translates to a NNT ≤ 3, which 0 1 (3) 1 (6) was considered a clinically important treatment effect for –1 changing the short-term natural history of nerve-related –2 2 (5) 1 (6) neck and arm pain. Assuming a prevalence of ‘improvement’ –3 in the control group of 10% and an overall drop-out rate of –4 1 (3) Con 10%, the trial required 84 participants (experimental = 56, –5 (n = 18) control = 28). –6 –7 Results Exp Flow of participants through the trial (n = 38) Participants were recruited from July 2009 through July 'JHVSF. Distribution and frequency of Global Rating of 2011. Of the 587 volunteers who responded to recruitment Change (GROC) scores at follow-up. The bold horizontal advertisements, 60 entered the trial. Although the a priori line represents the median and the upper and lower sample size was 84, recruitment stopped at 60 because time borders of the box represent the IQR. Whiskers represent constraints did not allow data collection to extend beyond the largest and smallest GROC scores that would not be two years. The flow of participants through the trial and considered ‘outliers’. Dots represent individual participants reasons for the loss to follow-up of two participants from with GROC scores that were ‘outliers’ for that group. the experimental group (5%) and two from the control Frequency of each GROC score expressed as n (%). group (10%) are presented in Figure 1. Exp = experimental (neural tissue management), Con = control (advice to remain active). Participants’ baseline characteristics are presented in Table 1. Those in the experimental group had their symptoms for longer and were more likely to be using medication. Control group participants were slightly more likely to report symptoms below the elbow and that arm symptoms were worse than neck symptoms. There were no important differences between groups in baseline scores for neck pain, arm pain, or Neck Disability Index. Journal of Physiotherapy 2012 Vol. 58 – © Australian Physiotherapy Association 2012. Open access under CC BY-NC-ND license. 27
Research 5BCMF ‘Worst case’ and ‘complete case’ analyses of number and proportion of participants in each group reporting a Global Rating of Change score classified as an ‘improvement’ or ‘worsening’. Outcome Exp Con Risk difference (95% CI) ‘Improved’ at follow-up (GROC ≥!* \"d%]hekfd ‘Worst case’ intention-to-treat analysis ('%*& +) )%(& '+ –38% ‘Complete case’ analysis ('%). ++ '%'. + (–16 to –60) ‘Worse’ at follow-up (GROC ≤¸( \"d%]hekfd –50% (–31 to –69) ‘Worst case’ intention-to-treat analysis +%*& ') *%(& (& –7% ‘Complete case’ analysis )%). . *%'. (( (–28 to 13) –14% (–35 to 7) Exp = experimental (neural tissue management), Con = control (advice to remain active), GROC = Global Rating of Change 5BCMF ‘Complete case’ analysis of mean (SD) follow-up scores for neck pain, arm pain and Neck Disability Index and mean (SD) change in Patient-Specific Functional Scale scores for each group, mean (95% CI) difference between groups, and standardised mean difference (95% CI) between groups. Outcome Exp Con Difference between Standardised mean (n = 38) (n = 18) groupsa differenceb Neck pain previous 24 hrs (0 to 10) 2.6 (2.4) 4.2 (2.2) –2.1 –0.9 2.4 (2.1) 4.0 (1.9) (–1.0 to –3.1) (–0.5 to –1.3) Arm pain previous 24 hrs (0 to 10) 8.9 (5.4) 11.2 (5.0) 2.0 (2.1) 0.4 (1.0) –1.5 –0.7 Neck Disability Index (0 to 50) (–0.5 to –2.6) (–0.3 to –1.1) Patient-Specific Functional Scalec –3.4 –0.6 change score (0 to 10) (–0.6 to –6.3) (–0.2 to –1.0) 2.1 0.9 (0.9 to 3.2) (0.5 to 1.3) a analysis of covariance (ANCOVA) with adjustment for baseline score, baseline medication use, and duration of symptoms as covariates; b adjusted for baseline score, baseline medication use, and duration of symptoms; c Note that because PSFS data were analysed as change scores, further adjustment for baseline score was not performed. Exp = experimental (neural tissue management), Con = control (advice to remain active) 5BCMF ‘Complete case’ analysis of number of participants (%) in each group who achieved clinically important change scores for impairments in pain intensity and participant-reported activity limitations, and number needed to treat (95% CI). Outcome Exp Con NNT (n = 38) (n = 18) (95% CI) Neck pain previous 24 hrs (0 to 10) 13 (34) 1 (6) 3.6 (decrease ≥ 2.2 points) 13 (34) 1 (6) (2.1 to 10.0) 11 (29) 1 (6) Arm pain previous 24 hrs (0 to 10) 15 (39) 1 (6) 3.6 (decrease ≥ 2.2 points) (2.1 to 10.0) Neck Disability Index (0 to 50) 4.3 (decrease ≥ 7 points) (2.4 to 18.2) Patient-Specific Functional Scale (0 to 10) 3.0 (increase ≥ 2.2 points) (1.9 to 6.7) Exp = experimental (neural tissue management), Con = control (advice to remain active), NNT = number needed to treat up received treatment as described except for one (3%) in neural tissue management in the opinion of the participant the experimental group and one (5%) in the control group. and physiotherapist and had resolved when the participant The experimental group participant received only three attended follow-up less than a week later. The control group treatments, which meant that the 38 participants in this participant attended four chiropractic treatments. Global group who completed follow-up received 151 treatments. Rating of Change scores indicated that neither participant Between treatments three and four, this participant was ‘improved’ or ‘worse’ at follow-up. These participants experienced an exacerbation of symptoms related to an were analysed with their assigned group. unusual amount of heavy lifting at work. The participant exhibited two abnormal neurological signs when assessed Effect of intervention prior to the fourth treatment and therefore was not treated. The exacerbation and neurological signs were not related to The distribution and frequency of Global Rating of Change scores at follow-up are presented in Figure 2. 28 Journal of Physiotherapy 2012 Vol. 58 – © Australian Physiotherapy Association 2012. Open access under CC BY-NC-ND license.
Nee et al: Neural tissue management for neck and arm pain 5BCMF Characteristics of unpleasant sensations that constituted adverse events that participants related to neural tissue management. Characteristic Unpleasant sensations Participants experiencing the (n = 82) unpleasant sensation during one or Type, n (%) Aggravation of neck pain more adverse events (n = 38) Aggravation of arm pain Aggravation of other symptomsa 17 (21) 14 (37) Arm weakness 14 (17) 12 (32) Tiredness or fatigue 5 (6) 5 (13) Headache 9 (11) 5 (13) Dizziness or imbalance 11 (13) 7 (18) Fainting 14 (17) 11 (29) Nausea or vomiting 2 (2) Blurred or impaired vision 0 (0) 1 (3) Tinnitus 0 (0) Confusion or disorientation 2 (2) 1 (3) Depression or anxiety 2 (2) 2 (5) 3 (4) 2 (5) Time of onset after treatment, n (%) 1 (1) 1 (3) < 30 min 2 (2) 2 (5) 30 min to 4 hr 4 to 24 hr 40 (49) > 24 hr 18 (22) 20 (24) Duration, n (%) < 10 min 4 (5) 10 min to 1 hr 1 to 24 hr 6 (7) > 24 hr 12 (15) 47 (57) Intensity (0 to 10 numeric rating scale), mean (SD) 17 (21) Restriction of home or work activities, n (%) 4.7 (2.1) None A little 24 (29) A lot 48 (59) 10 (12) a numbness, tingling The experimental intervention changed the short-term differences between groups. Therefore, Patient-Specific natural history of nerve-related neck and arm pain. ‘Worst Functional Scale change scores were analysed with an case’ intention-to-treat and ‘complete case’ analyses ANCOVA rather than an unpaired t-test. The experimental are presented in Table 2. Individual participant data are group had better follow-up scores for pain and activity presented in Table 3 (see eAddenda for Table 3). These risk limitations with ‘moderate’ standardised mean differences differences show that ‘improvement’ occurred significantly (≥ 0.6 but < 1.2) (Hopkins 2011) (Table 4). NNT values show more often among participants in the experimental group that substantially greater proportions of participants in the (Table 2). The ‘worst case’ analysis indicates that for every experimental group achieved clinically important change three patients treated, one more patient would achieve scores for neck pain, arm pain, Neck Disability Index, ‘improvement’ than would otherwise occur (95% CI 1.7 and Patient-Specific Functional Scale (Table 5). Individual to 6.5). The ‘complete case’ analysis indicates that for participant data for these outcomes are again presented in every two patients treated, one more patient would achieve Table 3 (see eAddenda for Table 3). ‘improvement’ than would otherwise occur (95% CI 1.5 to 3.3). Although nearly 60% of the experimental group were There was no evidence to suggest that neural tissue using medication at baseline, there was no relationship management was harmful. ‘Worst case’ intention-to- between medication use and improvement in this group (RR treat and ‘complete case’ analyses showed no difference 1.02, 95% CI 0.56 to 1.84). Analyses of follow-up scores in the prevalence of worsening between groups (Table for pain and activity limitations added medication use and 2). Additionally, no participants had to stop neural tissue duration of symptoms as covariates to account for baseline management early because of an exacerbation and associated Journal of Physiotherapy 2012 Vol. 58 – © Australian Physiotherapy Association 2012. Open access under CC BY-NC-ND license. 29
Research development of two or more abnormal neurological findings enrolment of the a priori sample of 84 participants. Although that they and the physiotherapist related to treatment. we anticipated that approximately 10% of volunteers would enter the trial, the response to each recruitment Adverse events advertisement was lower than expected. Enrolment stopped at 60 participants because data collection could not extend Sixteen participants (42%) reported an adverse event that beyond two years. The concern with early stoppage of a trial they related to neural tissue management after 29 of the 151 is that any treatment effect may reflect a ‘random high’ in treatments (19%). Questionnaires were returned for 25 of the data rather than the ‘true’ effect (Moher et al 2010). We the 29 adverse events. The characteristics of these adverse suggest that the large benefit of neural tissue management events are summarised in Table 6. On average, an adverse for participant-reported improvement in the short term event consisted of three to four unpleasant sensations (82 is unlikely to be a ‘random high’ in the data because the unpleasant sensations over 25 adverse events). Aggravation ‘worst case’ intention-to-treat analysis still revealed a NNT of neck or arm pain and headache were most common. of three with a relatively narrow 95% CI. Clinicians should Nearly all (95%) unpleasant sensations started within 24 remember that participants were recruited from the general hours of the previous treatment session and approximately community when interpreting our results. However, we are 80% lasted < 24 hours. Importantly, no additional unaware of any data showing that treatment effects differ treatments were needed for any unpleasant sensation and when samples with the same enrolment criteria are recruited 88% of unpleasant sensations had little or no impact on from the general community rather than the clinic. participants’ daily activities. Furthermore, experiencing an adverse event did not reduce a participant’s chance of Because advice to remain active was the control condition, benefitting from neural tissue management because there it is unclear whether observed benefits of neural tissue was no difference in improvement rates for participants management reflect non-specific effects due to interacting who did (9/16, 56%) and did not (12/22, 55%) experience an with a physiotherapist or participants’ expectations, adverse event (RR = 1.03, 95% CI 0.58 to 1.84). effects specific to neural tissue management, or to some combination. While discriminating non-specific from Discussion specific treatment effects is deemed important, establishing that neural tissue management can change the natural This randomised controlled trial examined the benefits history of nerve-related neck and arm pain was a necessary and harms of neural tissue management as an intervention prerequisite (Bialosky et al 2011). Assuming that a credible for nerve-related neck and arm pain. Low NNTs and comparison intervention can be developed to measure moderate standardised mean differences show that neural non-specific effects accurately, future research should tissue management produced clinically important benefits try to quantify the relative contributions that non-specific for participant-reported improvement, pain intensity, and and specific effects make to the benefits of neural tissue activity limitations at short-term follow-up when compared management. Future research should also determine to advice to remain active. There was no evidence to whether neural tissue management provides benefits in the suggest that neural tissue management was harmful. The longer term. Q prevalence of worsening was similar for the experimental and control groups, and no participants had to stop neural eAddenda: Table 3 available at jop.physiotherapy.asn.au tissue management early because of an exacerbation that they and the physiotherapist related to treatment. Although Ethics: The University of Queensland Medical Research several participants experienced adverse events that they Ethics Committee approved this study. All participants related to neural tissue management, these events would be gave written informed consent before data collection began. categorised as ‘mild’ because they did not require additional treatment, usually lasted < 24 hours, had minimal impact Competing interests: The authors have no competing on daily activities, and did not reduce a participant’s chance interests. of improving with neural tissue management (Carlesso et al 2011, Carnes et al 2010). The proportion of participants Support: This trial was funded internally by the Neuropathic assigned to neural tissue management who experienced an Pain Research Group, School of Health and Rehabilitation adverse event and the characteristics of these events are Sciences, The University of Queensland, Australia. The similar to those reported previously for manual therapy for funding source had no role in designing the study, collecting patients with neck pain (Hurwitz et al 2004). The results or analysing the data, or in reporting the results. Robert of this trial enable physiotherapists to have informed Nee is funded by an Endeavour International Postgraduate discussions with patients about the short-term benefits and Research Scholarship from the Australian Government and harms of neural tissue management for nerve-related neck a Research Scholarship from The University of Queensland, and arm pain. Australia. Standardised mean differences for pain were similar to Acknowledgements: The authors thank the participants results from the trial by Allison and colleagues (2002) (≥ and physiotherapists involved in this trial, and Benjamin 0.7 versus 0.71), while those for activity limitations were Soon Tze Chin and Lieszel Melo for assistance with larger (≥ 0.6 versus 0.34) (Gross et al 2004). The consistently randomisation. favourable results for neural tissue management support the hypothesis that the lack of statistical significance in this Correspondence: Associate Professor Michel Coppieters, previous trial was due to the small sample. Division of Physiotherapy, NHMRC Centre of Clinical Research Excellence in Spinal Pain, Injury and Health, The size and source of the sample, comparison to advice School of Health and Rehabilitation Sciences, The to remain active, and short-term follow-up are potential University of Queensland, Australia. Email: m.coppieters@ limitations of our study. Time constraints prevented uq.edu.au 30 Journal of Physiotherapy 2012 Vol. 58 – © Australian Physiotherapy Association 2012. Open access under CC BY-NC-ND license.
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Appraisal Correspondence Pain education is required for all physiotherapists I applaud Jones and Hush (2011) for their Editorial in the Such a process of formulation is almost intuitive in chronic December issue of Journal of Physiotherapy. pain due to the frequency of significant psychological and social concomitants to the pain. However, a similar Raising the profile of pain education is crucial as it enables diagnostic process is also essential in all acute situations, as ongoing advancement of our profession in many different it is common for there to be issues such as belief structures, ways. First, as the Editorial points out, it behoves all anxiety, family or work situations, that impact on the clinicians to have both a good grounding in basic science experience of pain. Failure to identify these factors will as well as the means to apply it to clinical practice. Second, lead to us not doing as good a job as we might. it should give us a better understanding of our patients and their needs. Third, these benefits will help to give us a Since JJ Bonica first championed the multidisciplinary competitive advantage in the health-care marketplace. environment in assessing and treating people with chronic pain, the unique contribution of different professions to Jones and Hush (2011) highlight the undoubted importance the understanding of pain treatment has grown. Jones and of undergraduate (including graduate-entry) physiotherapy Hush (2011) emphasise this multidisciplinary aspect of pain programs. However, it is also important that postgraduate education. Clinicians from other disciplines have so much education reflects the same aims. Speaking personally, a to offer to help us understand more fully the complexity postgraduate degree in Pain Management has revolutionised of pain. Few courses offer an opportunity to actually learn the way I treat all patients. with and from each other. The formal postgraduate study program with which I am involved (the postgraduate degree There is a common misconception that the pain sciences, program in Pain Management, Sydney Medical School, The or indeed a pain management approach, are only for those University of Sydney) is one of the few that provide such an involved in treatment of chronic pain sufferers. Nothing environment. could be further from the truth. The biopsychosocial model of pain has been championed in recent years. This I would encourage all physiotherapists to brush up on their model enables clinicians (either as an individual or in a pain science, both basic and clinical, as well as training multidisciplinary team) to perform a formulation of any clinicians of the future. person who is experiencing pain. A formulation examines all three domains of a person in pain (the biological body Tim Austin processes, the psychological background and response, and Partner, Camperdown Physiotherapy the environment in which the person lives) and suggests Associate Lecturer, The University of Sydney, Australia how those domains inter-relate to lead to the outcome of the experience of pain. It is not that physiotherapists have all Reference the skills in each of these areas. However, such an approach enables us to accept that there may be lots of contributors Jones LE, Hush J (2011) J Physiother 57: 207–208. to the pain being experienced by that person in front of us. 64 Journal of Physiotherapy 2012 Vol. 58 – © Australian Physiotherapy Association 2012
Appraisal Clinimetrics Pain Intensity Ratings Description Of the many options for the measurement of pain in clinical Reproducibility and validity of pain intensity: VAS and populations, the most commonly used are Visual Analogue NRS are generally regarded as acceptable for both research Scales (VAS) and Numerical Rating Scales (NRS) (Lichter- and practice. Although single-item measures generally Kelly 2007). While similar, these two measurement endure concerns regarding content validity, both scales tools employ slightly different methods to quantify pain. show strong associations with other measures of pain Although it is noted that pain is widely considered a intensity. Compared to more comprehensive instruments, multidimensional construct, measurement of pain intensity simplicity and ease of administration increase their is often recorded at the exclusion of the other dimensions. applicability to clinical practice. From a measurement While not denying the relevance and importance of the perspective, differences between the two scales are minimal emotional and evaluative aspects of pain, this summary although there are pros and cons for both measures. A concerns the measurement of pain intensity. VAS may be marginally more responsive by virtue of its greater number of response options but has been shown Pain intensity: VAS and NRS generally involve a single to be more difficult to understand for some patients which question that asks the patient to rate their pain intensity can result in more missing data. There is evidence that on either a 10 cm line (VAS) or by choosing a number, patients prefer an NRS and it can be administered over the usually between 0 and 10 (NRS). The ends of both scales phone if necessary, but there are questions as to whether it are anchored by some variant of ‘no pain at all’ and ‘pain possesses ratio properties. There is considerable variation in as bad as you can imagine’. A VAS is scored by measuring estimates of important change on the measures but figures how far along from the ‘no pain’ end point the patient marks of 30% change and approximately 2cm/2 points have been the line and the NRS by recording the number chosen. The suggested (Dworkin 2005, Ostelo 2005, Peters 2007). question specifies a time period, eg, right now, or over the past 24 hours, or over the past week, and also whether the patient should rate average pain, worst pain, or least pain, over that period. Commentary VAS and NRS scales have a long history of administration in clinical research and their use is supported by a considerable Assessment of pain intensity is fundamental to research and body of clinimetric research, scores on these measures practice in many areas of physiotherapy (Dworkin 2005, have also been shown to provide relevant prognostic APTA 2001). While the subjective nature of pain ratings information in some conditions. Overall, VAS and NRS has been a source of criticism, acceptance of the patient- measures provide a simple, easy to administer, and valid centred practice paradigm has highlighted the importance way of measuring pain intensity in clinical populations. The of such patient-reported outcomes. As with all outcome questions and scales are easy to standardise and interpret measures however, consideration of the factors that may and are applicable in research and clinical settings. influence reliability or validity is important. Some of the factors applicable to pain intensity VAS and NRS measures Steven J Kamper are standardisation of the question, scale and anchor The George Institute, The University of Sydney, Australia descriptors, temporal variations in pain, period of recall, and social setting (Von Korff 2000). References As mentioned above, pain intensity forms one component American Physical Therapy Association (2001) Phys Ther 81: of the multidimensional pain experience. In particular 9–746. assessors should consider measurement of the affective aspect of pain and also pain-related activity limitations. Dworkin RH (2005) Pain 113: 9–19. Relationships between these related domains are complex and their measurement may provide important information Lichter-Kelly L (2007) J Pain 8: 906–913. in assessing treatment effects, measuring course, or guiding management decisions. Ostelo RWJG (2005) Clin Rheumatol 19: 593–607. Peters ML (2007) Pain Medicine 8: 601–610. Von Korff (2000) Spine 25: 3140–3151. Journal of Physiotherapy 2012 Vol. 58 – © Australian Physiotherapy Association 2012 61
Appraisal Clinical Practice Guidelines Palliation in aged care A palliative approach to aged care in the community Latest update: 2011. Next update: Within 5 years. Patient Description: These guidelines present evidence for how to group: Adults aged over 65 years who have a progressive, deliver a palliative approach to care of the older adult in life-limiting illness or frailty who reside in their own, the community setting. It outlines different models of care, friends’, or relatives’ homes or retirement villages. the effectiveness of postacute transitional care programs Intended audience: Health care professionals providing or crisis care programs, and outlines tools to improve care for older people in the community. Additional palliative care such as technology and staff education. It versions: Companion documents include a booklet for provides information about and outlines evidence regarding older people and their families, a booklet for care workers, family carers, advanced health care planning and directives, and a document outlining the processes underpinning these psychosocial care, and spiritual support. Evidence for best practice recommendations. Expert working group: A the assessment and management of physical symptoms is guideline development group of seven Australian experts in provided, including issues such as pain, fatigue, respiratory cancer, palliative care, or aged care authored the guidelines. symptoms, and falls. More detailed information is provided A further 20 individuals wrote specific sections of the for older people with special needs such as those living with guidelines and a reference group of 19 individuals from a mental illness, those experiencing advanced Parkinson’s varied professional, government, and societal backgrounds disease, motor neurone disease, or dementia. Information also provided input. Funded by: Australian Government regarding how to provide a palliative approach to care for Department of Health and Ageing. Consultation with: Aboriginal and Torres Strait Islander people and those from National public consultation occurred in addition to focus diverse cultural and language groups is also provided. The groups and interviews with key stakeholders. Approved guidelines are supported by 75 references. by: The National Health and Medical Research Council of Australia. Location: The guidelines and companion Sandra Brauer documents are available at: www.palliativecare.org.au. The University of Queensland, Australia Type 2 diabetes 1SFWFOUJPOPGUZQFEJBCFUFT Latest update: 2009. Next update: Within 5 years. Patient Description: These guidelines present evidence about the group: Adults at risk of developing type 2 diabetes. Intended prevention of Type 2 diabetes at both an individual and audience: Clinicians, health promotion and public health population level, addressing the questions: Can Type 2 practitioners, planners and policy makers. Additional diabetes be prevented? How can it be prevented in high risk versions: Nil. Expert working group: Nine health individuals? How can high risk individuals be identified? professionals and a consumer representative comprised This 213 page document provides underpinning evidence the working group. The guidelines were developed by a regarding the effectiveness of lifestyle modification consortium comprising Diabetes Australia, Australian (including increasing physical activity, improving diet, Diabetes Society; the Australian Diabetes Educators’ weight loss), pharmacotherapy, and bariatric surgery to Association; the Royal Australian College of General prevent Type 2 diabetes. Evidence for modifiable and non- Practitioners; and The Diabetes Unit, Menzies Centre for modifiable risk factors for Type 2 diabetes is presented. Health Policy, and The University of Sydney. Funded by: Risk assessment tools are evaluated and recommendations Australian Government Department of Health and Ageing. made. Population strategies effective in reducing risk Consultation with: Expert advisory groups, stakeholder factors are detailed, and the cost effectiveness and socio- groups and consumers occurred via a targeted approach economic implications of preventing Type 2 diabetes are and a formal public consultation process. Approved by: discussed. A summary of recommendations and practice The National Health and Medical Research Council of points is provided on pp 6–7. Australia. Location: The guidelines are available at: www.diabetesaustralia.com.au/For-Health-Professionals/ Sandra Brauer Diabetes-National-Guidelines/ The University of Queensland, Australia Journal of Physiotherapy 2012 Vol. 58 – © Australian Physiotherapy Association 2012 63
Appraisal Correspondence Physiotherapists must collaborate with other stakeholders to reform pain management The need to update pain curricula for students undertaking • An audit of beliefs and likely practice behaviours physiotherapy degrees Australia-wide was well argued of emerging health professionals across health by Jones and Hush (2011) in their Editorial, highlighting disciplines and tertiary institutions in WA the significant gaps in current knowledge and skills in pain management among the emerging physiotherapy • Development of an evidence-based and consumer- workforce in Australia. Similar issues exist for the broader centred guide to low back pain which has received health workforce, as outlined in the National Pain Strategy inter-professional endorsement (Australian and New Zealand College of Anaesthetists 2010). • Implementation of a system inversion in tertiary pain medicine units, so that patients attend interdisciplinary We need to better prepare the emerging workforce to group-based pain education before seeing a pain manage the predicted substantial increase in this global specialist (STEPS project) area of need over the next 30 years (March and Woolf 2010, Woolf et al 2010). These epidemiologic data are consistent • Delivery of interdisciplinary, evidence-based with Australian projections for chronic health conditions education to GPs about best-practice management of generally and chronic pain specifically (KPMG 2009). spinal pain (GPEP project) While we agree that there is need to provide consistent evidence-based and interdisciplinary education in pre- • Delivery of interdisciplinary, evidence-based registration physiotherapy programs in Australia, it is also education to health professionals and consumers/ imperative to optimise the evidence-informed practical carers in rural and remote regions of WA regarding skills and knowledge of clinicians currently in the workforce best-practice management and self-management, and who are likely to remain working for some time. These respectively, of spinal pain (HPEP project) clinicians are likely to play an important role in shaping the beliefs and practice behaviours of the emerging workforce. • Development of a consumer-centred web platform for self-management of musculoskeletal pain Initiating a shift in beliefs and practice behaviours in any area is challenging and can only be sustained when • Establishment of an interdisciplinary musculoskeletal supported by parallel changes in systems and policy. Reform stakeholder forum (focused on the development and/ strategies, therefore, need to be developed and implemented or implementation of health policy and best practice in a multi-stakeholder partnership framework, such as a guidelines in the context of musculoskeletal pain). network or community of practice model, in order to be effective and sustainable (Ranmuthugala et al 2011). In It is possible that additional important initiatives are this regard, there are many opportunities for collaboration currently being undertaken throughout Australia. We among researchers, clinicians, consumers, and other propose that it would be beneficial to the physiotherapy stakeholders such as universities, health departments, rural community to communicate such initiatives more widely health services, and policy makers to drive much-needed as a mechanism to facilitate more co-ordinated health reform in this area. reform in the area of pain management and to highlight opportunities for collaboration by physiotherapists. In this While Jones and Hush (2011) review important curriculum regard, perhaps the Journal could offer a potential avenue reform in Canada and the US, we feel it is timely to highlight for such communication, for example via a supplemental some of the initiatives currently being undertaken in issue on pain? Western Australia (WA) to help close this gap and improve service delivery to consumers who live the experience of Helen Slater1,2 and Andrew Briggs1,3 pain. The key platform that has enabled implementation of 1Curtin University, 2Pain Medicine Unit, Fremantle these initiatives is the WA Health Networks, integrated into the Department of Health, WA. The aim of the of the WA Hospital and Health Service, Health Networks is to involve all stakeholders who share a 3Department of Health, Government of Western Australia common interest in health to interact and share information to collaboratively plan and facilitate implementation of Australia consumer-centred health services through development of evidence-informed policy and programs. The Spinal Pain References Working Group, as part of the Musculoskeletal Health Network, has been proactive in developing, implementing, Australian and New Zealand College of Anaesthetists (2010) and evaluating a number of projects to address state policy National Pain Strategy. Melbourne for service delivery in the context of spinal pain (Spinal Pain Model of Care 2009). Examples of such projects, which :[fWhjc[dj e\\ >[Wbj^ M[ij[hd 7kijhWb_W (&&/ ^jjf0%%mmm$ have been recently reported to Pain Australia as progress ^ [ W b j ^ d [ j m e h a i $ ^ [ W b j ^ $m W $ ] e l$ W k % c e Z [ b i e \\ Y W h [ %Z e Y i % towards local implementation activities of the National Pain If_dWbUFW_dUCeZ[bUe\\U9Wh[$fZ\\$ Strategy, include: Jones L Hush JM (2011) J Physiother 57: 207–208. AFC= (&&/ ^jjf0%%mmm$W^me$]el$Wk%ZeYkc[dji%D>MJ% The%20health%20workforce%20in%20Australia%20 and%20factors%20influencing%20current%20shortages. fZ\\QWYY[ii[Z@WdkWho(&'(S March L, Woolf AD (2010) Best Pract Res Clin Rheumatol 24: 721. Ranmuthugala G et al (2011) Implement Sci 6: 49. Woolf AD et al (2010) Best Pract Res Clin Rheumatol 24: 723– 732. Journal of Physiotherapy 2012 Vol. 58 – © Australian Physiotherapy Association 2012 65
Editorial Prevention needs to be a priority Leon Straker School of Physiotherapy, Curtin University, Australia Over one-quarter of the total health burden in Australia is per annum in 2003 to $246 billion per annum in 2033, and estimated to be due to five key modifiable lifestyle-related increase from 9% to 12% of gross domestic product. We risk factors: tobacco smoking, alcohol consumption, low simply cannot afford to continue doing business as usual fruit and vegetable intake, high body mass, and physical in health. inactivity (Begg et al 2007). Internationally, governments are grasping the overwhelming importance of prioritising 4. The five key modifiable health risks discussed below prevention and, although Australian data are used as often have broader social impact in addition to health examples in this Editorial, the issues and principles to burden. For example the estimated cost burden of alcohol in rectify them are relevant to most countries. In Australia a Australian society is $1.9 billion per annum for health, with national preventive health agency (ANPHA) has recently an additional $1.6 billion for crime, $2.2 billion for road been established. The purpose of the ANPHA is to promote trauma, $1.5 billion for lost productivity at home, and $3.5 effective primary prevention by contributing to policy and billion for lost productivity at work (NPHT 2009a). These practice through the better use of evidence and collaboration. figures are only the financial cost and do not include other The ANPHA ‘Knowledge Hub’ will provide links to online impacts on families and relationships. resources to assist physiotherapists to promote prevention to their clients, while the US Department of Health and Human 5. The most disadvantaged in our society are also those most Services provides tips for primary care professionals to raise at risk. The social imperative to ‘close the gap’ between prevention issues with their clients. National authorities Aboriginal and non-Aboriginal health is monumental with are providing online resources aimed at the community a 17 year-life expectancy gap (AHRC 2008). However, all to promote prevention. Physiotherapists have traditionally disadvantaged Australians are at greater risk of lifestyle been enthusiastic advocates of healthy lifestyles and the disorders. For example in 2001 the most disadvantaged new focus on prevention in Australia and internationally 20% of Australians had around double the rate of obesity creates a window of opportunity for physiotherapy to renew of the most advantaged 20% (obesity 22% versus 12% for efforts to improve the nation’s health through prevention. females; 20% versus 13% for males) (NPHT 2009b). Seven reasons to prioritise preventive health 6. Contrasting the ‘bad news’ is the ‘good news’ – that actions prevention can both improve health outcomes and reduce cost burdens. American estimates are that the return on Seven important factors have convinced authorities to investment for every $1 spent on preventive health is more prioritise prevention: declining life expectancy, rising than $5 within 5 years (Levi et al 2009). Recent Australian disease risk, impending cost burden, broad social impact, estimates for the impact of five interventions to increase inequity of risk, cost effectiveness, and efficacy. physical activity suggest a net cost saving of over $600 million as well as saving 61 000 disability-adjusted life 1. The life expectancy at birth of Australians is very good years (Vos et al 2010). (84 years for females, 79 years for males), ranking third internationally (AIHW 2010). Life expectancy in Australia 7. Early examples of effective prevention include the rose from 59/55 years early in the twentieth century to provision of clean water to reduce cholera and immunisation 70/65 years by mid-century due to better management of to prevent small pox. More recently improved road infectious disease and better hygiene and living standards. infrastructure, safer cars, random breath testing, and speed However, mid-century life expectancy plateaued and cameras have contributed to a halving in road deaths in actually declined for males due to chronic lifestyle diseases Australia over the last 30 years despite increased kilometres especially cardiovascular disease. Improved tertiary travelled (ATC 2008). Similarly, tobacco smoking rates in management of chronic disease has continued the increase Australia have been halved over the last 30 years, related in life expectancy since then. But once again there is to preventive actions such as bans on advertising and downward pressure on life expectancy, with estimates that sponsorship of events, as well as legislated smoke-free the impact of obesity alone is equivalent to a 2-year decline environments (NPHT 2009a). in life expectancy at a population level (D’Arcy and Smith 2008). Five key modifiable health behaviours 2. Lifestyle-related disorders are estimated to increase Tobacco smoking, alcohol consumption, low fruit and substantially over the next two decades. For example, the vegetable intake, high body mass, and physical inactivity number of Australians with diabetes is expected to increase account for an estimated 27% of the total Australian health from 1.1 million in 2003 to 3.6 million by 2033 (Goss 2008). burden (Begg et al 2007) through pathways to cancer, This is partly due to an ageing population but is also due to chronic obstructive pulmonary disease, heart disease, a near doubling of age-standardised risk. stroke, accidents, suicide, diabetes, and other disorders (AIHW 2010). Further, these risk behaviours often cluster 3. The cost burden associated with increased disease is also together (NPHP 2001). anticipated to increase exponentially. For example, the cost burden from diabetes is expected to increase seven-fold 1. Tobacco is smoked by only about 19% of Australian adults from 2013 to 2033 (Goss 2008). Australia’s total health and now (AIHW 2010), but this and the legacy of prior higher aged care expenditure is predicted to rise from $86 billion rates means it accounts for ~8% of the total health burden Journal of Physiotherapy 2012 Vol. 58 – © Australian Physiotherapy Association 2012. Open access under CC BY-NC-ND license. 5
Editorial in Australia (Begg et al 2007). The preventive guideline is consumption accounts for ~2% of the total health burden in to avoid smoking. Australia (Begg et al 2007). 2. Alcohol is consumed by 41% of Australian adults each 4. Around two-thirds of Australian adults are overweight, week and 83% in the past year (NHMRC 2009), with including one-quarter who are obese (AIHW 2010). Also ~15% reporting consumption at risky levels (AIHW 2010). of concern is that the proportion of Australian children Alcohol use accounts for ~3% of the total health burden who are overweight and obese has doubled in the last 25 in Australia (Begg et al 2007). The ‘safe’ levels of alcohol years, from one-eighth to one-quarter (NPHT 2009a). consumption have been revised downwards as newer Obesity (not including overweight) is estimated to account research suggests that beneficial effects from alcohol occur for ~8% of the total health burden in Australia (Begg et al only at very low levels or that there is no protective effect 2007). Australian guidelines recommend adults maintain a (NHMRC 2009), contrary to popular belief. The latest BMI < 25 and a waist circumference < 80 cm for women Australian National Health and Medical Research Council and < 94 cm for men (DHA 2006). Around two-thirds guidelines recommend that young people avoid alcohol for of Australian adults have insufficient moderate/vigorous as long as possible and adults consume no more than two physical activity (AIHW 2010). standard drinks on any day (NHMRC 2009). Of all the five key health risk behaviours, this one may be the most 5. Around one-third of Australian children have insufficient culturally challenging for many physiotherapists. moderate/vigorous activity (DHA 2008). Insufficient moderate/vigorous physical activity is estimated to account 3. Australian guidelines recommend two serves of fruit for ~7% of the total health burden in Australia (Begg et al and five serves of vegetables per day for adults and three 2007). National guidelines recommend adults accumulate serves of fruit and four serves of vegetables for adolescents 30 minutes or more of moderate activity on most, preferably (DHA 2009). Around 90% of Australian adults consume all, days along with some vigorous activity (DHA 2005a). less than two serves of fruit and five serves of vegetables For children, the recommendation is for 60 minutes of each day (AIHW 2010). Around 8% of primary school moderate/vigorous activity each day (DHA 2005b, DHA children consume insufficient fruit, rising to 76% of 2005c). This activity could be in the form of sport or adolescents (DHA 2008). Around 82% of primary school ‘exercise’ or any other activity that requires a moderate children consume insufficient vegetables, rising to 95% or greater physiological load. Recently, new evidence has of adolescents (DHA 2008). Low fruit and vegetable shown that total accumulated sedentary behaviour, and #PY Examples of preventive actions by physiotherapists. Include tips for 5 key health issues on specific handouts to clients such as exercise sheets Individual Local with students Enhance your own health by maintaining healthy behaviours Review course materials to link to key prevention actions were possible Model good health habits for family, friends, colleagues, and clients Encourage consideration of client’s general health and potential preventive actions by students and junior Give flowers or a dance music download voucher rather colleagues than alcohol Local with workplace and community Provide interesting non-al drinks at social gatherings 8h_d]jWijoiWbWZ%l[]]_[Z_i^[ijeieY_Wb]Wj^[h_d]i Create a ‘fruit club’ at work to encourage 2 fruits a day Meet friends for a walk-and-talk rather than cake and coffee Walk for meetings of 2–3 people, stand for meetings with more people Enhance your credibility when discussing with clients by modeling good habits Advocate for safe active transport routes to school Local with clients Support good food options at school shop Raise key health issues with clients, in addition to dealing Flash your car lights randomly to encourage safe driving with their presenting complaint speeds Add standard screening questions about lifestyle factors Promote mass media prevention campaigns through your to your assessment social media network Do some preparation so you are comfortable to raise key Offer advocacy in this area with local businesses health issues with clients Write to your local council member or community Put up prevention posters in clinic waiting room newspaper supporting initiatives like smoke-free public areas or better cycling and walking paths Run monthly themes in your practice highlighting a key modifiable health issue /BUJPOBM*OUFSOBUJPOBM Provide a weight, height and BMI calculation station in Write or, better still, go to see your local member to clinic waiting room support preventive legislation such as speed cameras, cigarette plain packaging, tobacco tax, and food labeling Provide pamphlets on resources for clients wishing to address a key health issue once raised Add links from your practice website to resources for clients on preventive issues 6 Journal of Physiotherapy 2012 Vol. 58 – © Australian Physiotherapy Association 2012. Open access under CC BY-NC-ND license.
Editorial in particular uninterrupted sustained periods of sitting, Australia. Australian Human Rights Commission, Canberra. increase cardiometabolic risk independent of moderate/ vigorous physical activity habits (Healy et al 2011). Thus Begg S, et al (2007) The burden of disease and injury in a sedentary office worker not only needs a daily moderate/ Australia 2003. Australian Institute of Health and Welfare, vigorous activity such as a morning run, but also needs to Canberra. reduce overall time sitting and to break up sustained periods of sitting. This is creating an interesting convergence of D’Arcy C, Smith F (2008) Implications of the obesity epidemic musculoskeletal and cardiometabolic health. Currently, the for the life expectancy of Australians. Western Australian only Australian national guidelines regarding sedentary Institute for Public Health Policy, Perth. behaviour recommend keeping leisure screen-based activity to less than 2 hours per day for children (DHA 2005b). Department of Health and Ageing (2005a) Australia’s physical Musculoskeletally-focused computer use guidelines have activity recommendations for Adults. Commonwealth of recommended postural variety and active breaks away Australia, Canberra. from seated computer use every 30–60 minutes (Straker et al 2010). Thus national guidelines can now be refined and Department of Health and Ageing (2005b) Australia’s physical extended to recommend reduction in total daily sedentary activity recommendations for 5–12 year olds. Commonwealth behaviours and avoidance of uninterrupted sedentary of Australia, Canberra. periods of more than 30–60 minutes. Department of Health and Ageing (2005c) Australia’s Opportunity for physiotherapists physical activity recommendations for 12–18 year olds. Commonwealth of Australia, Canberra. Despite advances in tertiary care, the health of populations in affluent countries is declining. The impending cost Department of Health and Ageing (2006) What is a healthy burden of dealing with lifestyle-related health disorders weight? Commonwealth of Australia, Canberra. will overwhelm current health service delivery models. Therefore we must prioritise prevention now to optimise the Department of Health and Ageing (2008) 2007 Australian health of the population. national children’s nutrition and physical activity survey. Commonwealth of Australia, Canberra. Currently there is a window of opportunity created by government urgency to reform health systems and support Department of Health and Aging (2009) The Australian guide to other preventive initiatives to reduce the impending healthy eating. Commonwealth of Australia, Canberra. disease burden. Physiotherapists could play a major role in preventive health – but if we don’t there are many other Goss J (2008) Projection of Australian health care expenditure groups who will take on this vital role for our society. by disease, 2003–2033. Australian Institute of Health and Welfare. Canberra. A desire to help people live healthier, happier, and more functional lives by reducing the burden of disease and Healy GN, et al (2011) Eur Heart J 32: 590–597. injury is a driving motivation to enter the physiotherapy profession and to remain a physiotherapist. As a profession Levi J, et al (2009) Prevention for a healthier America: we have long promoted the notion to ‘move well, stay investments in disease prevention yield significant well’. We now have a wonderful opportunity to leave the savings, stronger communities. Trust for America’s Health, world a better place by: modelling healthy behaviours, Washington, USA. teaching our students the importance of prevention, raising the issue of health behaviours with our clients regardless National Health and Medical Research Council (2009) of their presenting condition, and taking other preventive Australian guidelines to reduce the health risks from drinking actions at individual, local, and broader community levels alcohol. Commonwealth of Australia, Canberra. (NPHP 2006). The National Preventative Health Strategy provides an extensive roadmap for preventive actions at all National Preventative Health Taskforce (2009a) Australia: The levels (NPHT 2009a) and Box 1 provides some examples healthiest country by 2020. National Preventative Health of preventive actions physiotherapists could take. Given Strategy – the roadmap for action. Commonwealth of our knowledge and skill base and our respected status Australia, Canberra. in society, physiotherapists can be at the forefront of the renewed international prioritising of prevention. For your National Preventative Health Taskforce (2009b) Australia: own health, for the health of your clients and students, and The healthiest country by 2020. Technical Report 1 Obesity for the health of the human race, I urge you to prioritise in Australia: a need for urgent action. Commonwealth of prevention. Australia, Canberra. References National Public Health Partnership (2001) Preventing chronic disease: a strategic framework. National Public Health Australian Transport Council (2008) National road safety action Partnership, Melbourne. plan 2009 and 2010. Australian Transport Council, Canberra. National Public Health Partnership (2006) The language of Australian Institute of Health and Welfare (2010) Australia’s prevention. National Public Health Partnership, Melbourne. health 2010. Australian Institute of Health and Welfare, Canberra. Straker L, et al (2010) Ergonomics 53: 458–477. Australian Human Rights Commission (2008) A statistical Vos T, et al (2010) Assessing the cost-effectiveness in overview of Aboriginal and Torres Strait Islander peoples in prevention. The University of Queensland, Brisbane, and Deakin University, Melbourne. Websites www.anpha.gov.au mmm$YZY$]el%>[Wbj^oB_l_d] www.healthyactive.gov.au mmm$^[Wbj^oWYj_l[$]el$Wk%_dj[hd[j%^[Wbj^oWYj_l[%fkXb_i^_d]$ di\\%9edj[dj%^[Wbj^o#m[_]^j www.measureup.gov.au mmm$d^i$ka%b_l[m[bb mmm$m_d$d_ZZa$d_^$]el%fkXb_YWj_edi%jWba_d]$^jc Journal of Physiotherapy 2012 Vol. 58 – © Australian Physiotherapy Association 2012. Open access under CC BY-NC-ND license. 7
Appraisal Clinimetrics Rating of Perceived Exertion (RPE) Description Rating of Perceived Exertion (RPE) is a used to subjectively As with most subjective scales, large inter-individual quantify an individual’s perception of the physical demands variability exists, hence caution needs to be considered in of an activity. The most widely used RPE tool is the ‘Borg the universal application of these scales (Chen et al 2002). scale’ – a psychophysical, category scale with rating Individual ratings are influenced by psychological factors, ranges from 6 (no exertion at all) to 20 (maximal exertion) mood states, environmental conditions, exercise modes, (ACSM 2010). Subsequent scales include a category-ratio and age. Thus, these tools may be inappropriate for some scale (CR10) with rating ranges from 0 (nothing at all) to individuals. 10 (extremely strong) (Borg 1998), and the OMNI-RPE – a 0–10 RPE scale with mode-specific pictures (Robertson Instructions to client: Patients/clients must be taught to 2004). The Borg and CR10 scales have shown reliability and use, and allowed to practise an RPE scale. Initially, the validity in healthy, clinical and athletic adult populations client’s heart rate should be monitored and related to his (Chen et al 2002), whereas the OMNI-RPE has shown or her RPE (Mackinnon et al 2003). Importantly, clients greater reliability and validity with paediatric populations should understand that the rating relates to overall exertion (Robertson et al 2004). and not exertion of a particular body part. Instructions to provide a rating of overall ‘effort, strain, discomfort and RPE is usually used in one of two modes: in estimation fatigue’ may minimise ratings related to localised soreness. mode the patient/client provides an RPE during a prescribed activity. For example, RPE used in conjunction Reliability and validity: Originally validated against with objective measures of exercise tolerance (eg, heart heart rate (r = 0.80–0.90), RPE has since been researched rate, ECG) during clinical exercise testing may help extensively (ACSM 2010, Chen et al 2002). A meta- monitor exercise tolerance and impending fatigue (ACSM analysis that considered moderating variables such as 2010). In production/prescription mode RPE is provided sex, fitness level, psychological status, and mode of as an exercise intensity guide (eg, low intensity exercise is exercise showed that although the validity of RPE was prescribed at 10–11 on the Borg scale (2 on the 0–10 scale), not as high as originally reported, the relationships with moderate intensity at 12–13 (3–4 on the 0–10 scale), and physiological measures of exercise intensity remained high intensity at 14–16 (4–6 on the 0–10 scale)) (Mackinnon high (Chen et al 2002). Interestingly, compared with et al 2003). the estimation mode (heart rate, r = 0.62; blood lactate concentration, r = 0.57; maximal oxygen uptake, r = RPE is often the prescription method of choice for patients/ 0.74), the strength of the relationships were higher for clients taking medication (eg, beta blockers) that affects the production mode (heart rate, r = 0.66; blood lactate exercise heart rate. Likewise, immersion in water also concentration, r = 0.66; maximal oxygen uptake, r = 0.85). affects heart rate, hence RPE is also helpful for athletes and others prescribed water-based activities (Hamer et al 1997). Commentary RPE is not without limitations. Joo and colleagues (2004) reported that 80% of cardiac rehabilitation patients Physical activity is an important component of many prescribed exercise at a RPE of 11 to 13 exercised at levels rehabilitation programs. Exercise intensity is probably the deemed to be unsafe (eg, > 60% VO2R). To ensure the safety most important component of the exercise prescription in and efficacy of the exercise prescription, care must be taken terms of safety and efficacy (ACSM 2010). A sufficient level to ensure correct instruction and use of any of the RPE of intensity is needed to induce a training effect without scales. initiating abnormal clinical signs and symptoms. Typically, heart rate is used to monitor heart rate. However, some Carrie Ritchie medications, autonomic dysfunction, mode of exercise, Centre of National Research on Disability and environmental conditions, and psychological influences may Rehabilitation Medicine, The University of Queensland, affect heart rate and heart rate response to exercise. RPE is one method that may help clients/patients monitor exercise Australia intensity without the need to palpate pulse (Mackinnon et al 2003, Newcomb et al 2011). References RPE has been shown to be a useful tool for patients with ACSM (2010) ACSMs Guidelines for Exercise Testing and multiple sclerosis (Morrison et al 2008), fibromyalgia Fh[iYh_fj_ed$F^_bWZ[bf^_W0B_ff_dYejj\"M_bb_Wci M_ba_di$ (Newcomb et al 2011), and heart disease (ACSM 2010) as well as pregnant women (ACSM 2010) and athletes Borg G (1998) Borg’s Perceived Exertion and Pain Scales. recovering from injury (Hamer et al 1997). Moreover, RPE Champaign: Human Kinetics. helps an individual learn to self-monitor physical exertion and may help enhance exercise adherence (Mackinnon et al Hamer P et al (1997) Aust J Physiother 43: 265–271. 2003, Newcomb et al 2011). Mackinnon L et al (2003) Exercise Management: Concepts and Professional Practice. Champaign: Human Kinetics. Morrison et al (2008) Arch Phys Med Rehab 89: 1570–1574. Newcomb et al (2011) Med Sci Sport Exer 43: 1106–1113. 62 Journal of Physiotherapy 2012 Vol. 58 – © Australian Physiotherapy Association 2012
Appraisal Correspondence Response We thank Dr Whiteley for his interest in our study. person for whom the pre-test probability was 50%) the test would change the estimated probability of TFCC injury to Dr Whiteley argues that likelihood ratios cannot be used 84%, a change in probability of 34%. This test would aid to make judgements about the accuracy of a diagnostic test diagnosis a bit but not much – with a post-test probability because the post-test probability generated by a diagnostic of 84% we would still not be confident that the person test depends on the pre-test probability. Consequently he does have a TFCC injury. So a descriptor of ‘moderately believes that our conclusion – that provocative wrist tests useful’ seems, if anything, generous. The absolute change are of limited value for diagnosing wrist ligament injuries – in probability produced by a test finding is always greatest misrepresents the data. for a pre-test probability of 50%, so in all other scenarios this test modifies the probability of the diagnosis by less Post-test probabilities do, of course, depend on pre-test than 34%. probabilities (Herbert et al 2011). Likelihood ratios quantify the extent to which a diagnostic test modifies pre-test We stand by the specific assertion that MRI tests are probabilities. Accurate diagnostic tests substantially modify moderately useful for the diagnosis of TFCC injury and the pre-test probabilities, especially in cases of uncertainty general assertion that provocative wrist tests are of limited (when pre-test probabilities are neither very low nor very value for diagnosing wrist ligament injuries. Readers who high). In contrast, inaccurate tests (tests which carry little object to our interpretation of the data are free to do their diagnostic information) have very little effect on pre-test own calculations and use their own descriptors of the probabilities. usefulness of these tests. The descriptors that we used to describe test accuracy were Rosemary Prosser, Lisa Harvey, Paul LaStayo, Ian based on those recommended by Portney and Watkins Hargeaves, Peter Scougall and Rob Herbert (2009). In our opinion these descriptors are, if anything, a little too generous. By way of illustration, consider the References best positive likelihood ratio we reported: MRI diagnosis of TFCC injuries had a positive likelihood ratio of 5.6, so Herbert RD, et al (2011) Practical Evidence-Based it was classified as a ‘moderately useful’ test. If we were Physiotherapy (2nd edn). Oxford: Elsevier. to use this test on a person for whom we felt completely ambivalent about the diagnosis of TFCC injury (ie, on a Portney LG, Watkins MP (2009) Foundations of Clinical Research: Applications to Practice (3rd edn). Upper Saddle H_l[h0F[Whied%Fh[dj_Y[>Wbb$ Journal of Physiotherapy 2012 Vol. 58 – © Australian Physiotherapy Association 2012 67
Hallegraeff et al: Stretching for nocturnal leg cramps Stretching before sleep reduces the frequency and severity of nocturnal leg cramps in older adults: a randomised trial Joannes M Hallegraeff1, Cees P van der Schans1,2, Renee de Ruiter2 and Mathieu HG de Greef1,2 1Hanze University of Applied Sciences, Groningen, 2University Medical Center Groningen, Groningen University The Netherlands 2VFTUJPO In adults who experience nocturnal leg cramps, does stretching of the calf and hamstring muscles each day just before sleep reduce the frequency and severity of the cramps? %FTJHO A randomised trial with concealed allocation and intention-to-treat analysis. 1BSUJDJQBOUT Eighty adults aged over 55 years with nocturnal leg cramps who were not being treated with quinine. *OUFSWFOUJPO The experimental group performed stretches of the calf and hamstring muscles nightly, immediately before going to sleep, for six weeks. The control group performed no specific stretching exercises. Both groups continued other usual activities. 0VUDPNFNFBTVSFT Participants recorded the frequency of nocturnal leg cramps in a daily diary. Participants also recorded the severity of the pain associated with nocturnal leg cramps on a 10-cm visual analogue scale. Adverse events were also recorded. 3FTVMUT All participants completed the study. At six weeks, the frequency of nocturnal leg cramps decreased significantly more in the experimental group, mean difference 1.2 cramps per night (95% CI 0.6 to 1.8). The severity of the nocturnal leg cramps had also decreased significantly more in the experimental group than in the control group, mean difference 1.3 cm (95% CI 0.9 to 1.7) on the 10-cm visual analogue scale. $PODMVTJPO Nightly stretching before going to sleep reduces the frequency and severity of nocturnal leg cramps in older adults. 5SJBMSFHJTUSBUJPO NCT01421628. <)BMMFHSBFGG+. WBOEFS4DIBOT$1 EF3VJUFS3 EF(SFFG.)( 4USFUDIJOHCFGPSFTMFFQSFEVDFT UIFGSFRVFODZBOETFWFSJUZPGOPDUVSOBMMFHDSBNQTJOPMEFSBEVMUTBSBOEPNJTFEUSJBMJournal of Physiotherapy o> ,FZXPSET Nocturnal leg cramps, Muscle stretching exercises, Older adults Introduction It is important to distinguish nocturnal leg cramps from restless legs syndrome and periodic limb movement disorder, Nocturnal leg cramps are suddenly occurring, episodic, because all are sleep disorders characterised by abnormal painful, sustained, involuntary muscle contractions of the leg movements and reduced sleep quality. However, restless calf muscles, hamstrings, or foot muscles (Monderer et al legs syndrome involves more continuous discomfort and 2010, Sontag and Wanner 1988). During the cramp, the the urge to move the legs, occurs during the day also, and involved muscles are tender and hard on palpation. The pain is relieved by movement. Periodic limb movement disorder that occurs with these contractions is sharp and intense and causes involuntary limb movements (primarily of the legs) may last from seconds to several minutes. Although they during sleep, recurring at brief intervals, but not necessarily are otherwise benign, nocturnal leg cramps can cause waking the person (Khassanweh 2005). Therefore, the substantial distress and can disrupt sleep. In 20% of people diagnosis of nocturnal leg cramps can be based on reports who experience nocturnal leg cramps, cramps also occur of episodes of painful involuntary contractions of muscles, during the daytime (Monderer et al 2010). The cramps affecting the leg, calf, or foot, which occur at night and sometimes occur in episodes a few days a week, during which recur at sporadic intervals (Kanaan and Sawaya which they repeat themselves (Kanaan and Sawaya 2001, 2001, Butler et al 2002). Stewart et al 1993, Monderer et al 2010). Although the insults generally persist for no longer than ten minutes, in 8IBUJTBMSFBEZLOPXOPOUIJTUPQJD Nocturnal leg exceptional situations they can continue for several hours. cramps are common among the elderly, causing pain In approximately 2% of cases, nocturnal leg cramps occur and sleep disturbance. The medications used to prevent weekly (Abdulla et al 1999). Nocturnal leg cramps occur nocturnal leg cramps have variable efficacy and may more commonly with advancing age, affecting between have substantial side effects. 38% and 50% of the elderly (Butler et al 2002, Abdulla et al 1999, Sontag and Wanner 1988). Nocturnal leg cramps 8IBUUIJTTUVEZBEET Nightly stretching of the calves are more prevalent among women and among people with and hamstrings reduces the frequency of nocturnal leg comorbidities, especially those with neurological and cramps in older adults. Nightly stretching also lessens cardiovascular diseases (Butler et al 2002, Stewart et al the pain associated with any cramps that continue to 1993). occur. Journal of Physiotherapy 2012 Vol. 58 – © Australian Physiotherapy Association 2012. Open access under CC BY-NC-ND license. 17
Research The cause of nocturnal leg cramps is unknown. However, calf muscles immediately before going to bed reduce several possible causes and precipitating factors have been the frequency and severity of the cramps? hypothesised. Abnormal excitability of motor nerves, perhaps due to electrolyte imbalance, may be a contributing Method mechanism (Monderer et al 2010). Diuretics, steroids, morphine, and lithium are also reported to cause nocturnal Design cramps, as can repetitive movements during sport (Butler et al 2002, Kanaan and Sawaya 2001, Monderer et al A randomised trial was conducted at a physical therapy 2010). Conversely, physical inactivity has been proposed clinic in Groningen, with participants recruited through as a cause, with inadequate stretching leading to reduced advertisement in local newspapers in the northern part of muscle and tendon length (Monderer et al 2010, Sontag and the Netherlands. At baseline, each participant’s age, gender, Wanner 1988). Although it is not fully understood how this and history of nocturnal leg cramps were recorded. After could lead to nocturnal leg cramps, this would be consistent eligibility was verified and written informed consent was with the higher prevalence of the disorder among people obtained, participants underwent measurement of their body with reductions in lower limb activity and joint range, such mass index, daily physical activity, and functional lower as those with varicose veins and arthritis (Abdullah et al limb strength, as described in detail below. Participants were 1999, Stewart et al 1993, Sontag and Wanner 1988, Hirai then randomised to either an experimental (daily stretches 2000). before sleep) or a control (no stretching) group, based on a computer-generated assignment schedule that was Quinine and hydroquinine are moderately effective in coded and concealed until after the study. An independent reducing the frequency and severity of nocturnal leg researcher assigned each patient to either the experimental cramps (El-Tawil et al 2010, van Kan et al 2000), perhaps by group or the control group. Participants allocated to the decreasing the excitability of the motor end plate and thereby experimental group were taught the stretches and those increasing the refractory period of a muscle (Vetrugno et al in the control group were advised not to stretch. Other 2007). However, quinine can have important side effects, investigators and care providers were blinded to group especially for women, such as: thrombocytopenia, hepatitis, assignment. Outcome measures were cramp frequency and high blood pressure, tinnitus, severe skin rash, and severity, recorded by participants daily in a diary during haemolytic uremic syndrome (Aronson 2006, Inan-Arslan et Week 0 and Week 6. al 2006). If hydroquinine is used, a trial intervention period is advised to monitor side effects (Monderer et al 2010, The methods used to characterise participants at their Inan-Arslan et al 2006). Although other medications have baseline visit were as follows. Body mass index was been used to treat nocturnal leg cramps such as magnesium, calculated from height and weight, which were measured Vitamin B Complex Forte, calcium, and vitamin E, none on calibrated instruments. Daily physical activity was of these appears to be effective (Anonymous 2007, Daniell measured by a pedometera fitted to each participant’s belt 1979). #PY Description of the stretching exercises. Muscle stretching is worth considering as an alternative therapy. It is easy to perform, has a very low risk of side Stretch Description effects, and often relieves the pain when a cramp has Calf stretch in occurred. Moreover, stretching techniques can foster a standing 4UBSUJOHQPTJUJPO Standing facing resilient attitude toward recovery in patients with nocturnal a wall with the elbows extended and leg cramps by promoting a ‘bounce back and move on’ Hamstring both palms on the wall at chest height. behavioural strategy (Norris et al 2008), because they give stretch in One leg is forward with the knee flexed patients a strategy to seek immediate relief. standing and the other leg is back with the knee extended. Both feet are in full contact Daniell (1979) examined a program of calf-stretching Hamstring with the floor. exercises performed three times per day by people with and calf nocturnal leg cramps. Although the program of stretches stretch in .PUJPOUPBQQMZTUSFUDI Flex the front appeared to prevent nocturnal leg cramps, the study lacked sitting knee so that the trunk moves forward, a randomised control group for comparison. In contrast, keeping the trunk straight and the heels Coppin and colleagues (2005) performed a randomised in contact with the floor. controlled trial in which the stretching exercises failed to decrease the frequency and severity of nocturnal leg cramps 4UBSUJOHQPTJUJPO Standing facing a in older adults. However, in this study all participants were chair that is placed against a wall. Place already taking quinine at baseline and continued taking it one heel on the chair with the knee of throughout the study, which may have reduced the potential that leg fully extended. for stretching to affect the outcome. Also, the stretching was performed three times ‘spread through each day’ .PUJPOUPBQQMZTUSFUDI Flex at the without further prescription or recording of the actual hips so that the trunk tilts forward, times. Because nocturnal leg cramps occur primarily at keeping the trunk straight. The foot on night and may be associated with physical inactivity and the floor should maintain full contact muscle shortening, stretching immediately before sleep may and the other heel remains in contact be a useful preventative therapy. Therefore, the research with the chair. question for this study was: 4UBSUJOHQPTJUJPO Sit on the floor or a In older adults who suffer from nocturnal leg cramps, firm bed with both legs extended. Grasp does a 6-week program of stretching the hamstring and toes with both hands. .PUJPOUPBQQMZTUSFUDI Flex at the hips so that the trunk tilts forward, keeping the trunk as straight as possible. Dorsiflex at the ankles. 18 Journal of Physiotherapy 2012 Vol. 58 – © Australian Physiotherapy Association 2012. Open access under CC BY-NC-ND license.
Hallegraeff et al: Stretching for nocturnal leg cramps for one week. The participants received instructions on a how to use the pedometer. The step count mechanism in this pedometer has elsewhere been shown to give values b consistently within 3% of the actual steps taken during a self- paced walk, with Cronbach’s Alpha of 0.99 for intra-model c reliability (Schneider et al 2003). Participants were strongly 'JHVSF Stretches used in the experimental group: (a) encouraged not to make any changes to their typical daily calf stretch in standing, (b) hamstring stretch in standing, routine of work and leisure activity. Patients were instructed (c) hamstring and calf stretch in sitting. to wear the pedometer for seven days and to record daily the number of steps and the number of minutes that they cycled, Outcome measures swam, or participated in any other activity. Non-ambulatory At an instruction visit prior to starting the study, participants activities were converted into steps based on the intensity were instructed in the daily recording of the frequency and of the physical activity calculated in metabolic equivalents severity of nocturnal leg cramps. The primary outcome was per minute (MET/min). For example, one minute of cycling the change in the average number of nocturnal leg cramps or swimming translates to about 150 steps, whereas one per day over a one-week period. This was assessed in the minute of moderate fitness-related activity corresponds to week prior to starting the 6-week stretching program (Week about 100 steps. Steps per day, including converted steps, 0) and again in the final week of the stretching program were expressed as step equivalents. Functional leg strength (Week 6). was measured with the chair-stand test which assesses The secondary outcome was the severity of nocturnal leg leg strength, and is commonly used in generally active, cramps. The severity was marked by the participants on a community-dwelling older adults (Jones et al 2000). In this 10-cm visual analogue scale with 0 cm representing no pain test, older adults stand up from a sitting position in a chair and 10 cm representing the worst pain the participant could as often as they can in 30 seconds. The chair-stand test has imagine. Recordings were again made in the daily diary a reliability (test-retest) of r = 0.88 and a convergent validity over the same 1-week periods before and at the end of the of r = 0.75. Participants To be included in the study, respondents to the study advertisement had to be over 55 years old and to experience regular episodes of nocturnal leg cramps, defined as at least once per week. Potential participants were excluded if they were using quinine or medication to assist sleep. They were also excluded if they had orthopaedic problems, severe medical conditions, or comorbidities known to cause muscular spasms or cramps. Intervention Participants in the experimental group attended a 45- min visit at which they were taught a program of daily stretching exercises for the hamstring and calf muscles by one physiotherapist, who was specially trained in the study procedures. Participants were advised to perform the stretches in standing, as presented in Figure 1a and b and described in Box 1. For each stretch, the participant was advised to adopt the position shown, move to the comfortable limit of motion, move beyond this to until a moderately intense stretch was felt and sustained for 10 seconds, and then return to the starting position. Participants were instructed to remain calm and never to hold their breath during the stretch. Each stretch was performed a total of three times, with 10 seconds of relaxation between each stretch. Stretching of both legs was done within three minutes. The physiotherapist demonstrated the stretches first and then observed the participant performing the stretches, correcting the technique if necessary. If a participant found stretching in standing difficult, the participant was shown how to stretch in a sitting position, as presented in Figure 1c and described in Box 1. The control group were not taught any sham stretches and were advised not to commence stretches. All participants were encouraged to maintain all other usual activity unchanged. At week 4, all participants received a home visit to assess and encourage adherence to the study protocol. Journal of Physiotherapy 2012 Vol. 58 – © Australian Physiotherapy Association 2012. Open access under CC BY-NC-ND license. 19
Research Older adults with nocturnal leg pain and leg cramps screened at intake (n = 119) Excluded (n = 39) ineligible (n = 37) declined to participate (n = 2) Screened physically (n = 80) Measured frequency and severity of nocturnal leg cramp for one week Week 0 Randomised (n = 80) (n = 40) (n = 40) Loss to follow-up Experimental Control Loss to follow-up (n = 0) (n = 0) Pre-sleep No stretches stretching Maintain usual Maintain usual activities activities Week 6 Measured frequency and severity of nocturnal leg cramp for one week (n = 40) (n = 40) 'JHVSF Design and flow of participants through the trial. 5BCMF Baseline characteristics of participants. Randomised Total Characteristic Exp Con (n = 80) (n = 40) (n = 40) 70 (6) Age (yr), mean (SD) 46 (58) Gender, n males (%) 67 (7) 72 (7) 25.4 (3.6) BMI (kg/m2), mean (SD) 20 (50) 26 (65) 18 (23) ≥1 chronic disorder, n (%) 26.0 (3.0) 24.9 (3.8) 7868 (3259) Physical activity (steps/d), mean (SD) 9 (23) 9 (23) Site of nocturnal cramps, n (%) 7780 (2644) 7956 (3810) 20 (25) 6 (8) calf 11 (28) 9 (23) hamstrings 2 (5) 4 (10) 34 (43) calf and hamstrings 17 (43) 20 (25) whole leg 17 (43) 10 (25) 11 (12) Cramp duration (mo), mean (SD) 10 (25) 12 (14) 12 (3) Chair-stand test (stands/30 s), mean (SD) 10 (8) 12 (3) 12 (3) 20 Journal of Physiotherapy 2012 Vol. 58 – © Australian Physiotherapy Association 2012. Open access under CC BY-NC-ND license.
Hallegraeff et al: Stretching for nocturnal leg cramps 5BCMF Mean (SD) of groups, mean (SD) difference within groups, and mean (95% CI) difference between groups for both outcomes. Groups Difference within groups Difference between Week 6 minus Week 0 groups Outcome Week 6 minus Week 0 Week 0 Week 6 Exp Con Exp Con Exp Con Exp minus Con (n = (n = (n = (n = 40) 40) 40) 40) –2.0 –0.8 –1.2 (1.3) (1.3) (–0.6 to –1.8) Cramp frequency 3.4 3.2 1.4 2.4 (1.4) (1.7) –1.3 0.0 –1.3 (cramps/night), mean (1.5) (1.9) (1.1) (0.9) (–0.9 to 1.7) 5.9 7.5 (SD) (1.4) (1.3) Cramp severity (0 to 7.2 7.4 10), mean (SD) (1.4) (1.3) Exp = experimental group, Con = control group, shaded row = primary outcome 6-week stretching program. If adverse events were present, both groups over the 6-week intervention period. However, they were recorded daily in the diary card throughout the the reduction in frequency was significantly greater in the trial. experimental group, by a mean of 1.2 cramps per night (95% CI 0.6 to 1.8). Data analysis The severity of nocturnal leg cramps did not improve at We sought to identify a difference in the average number all in the control group. However, there was a substantial of nocturnal leg cramps of 1 cramp per night. Anticipating reduction in the experimental group. The mean difference a standard deviation of 1.4 cramps per night (Coppin et al in improvement in the severity of the nocturnal leg cramps 2005), we calculated that we would require 32 participants was 1.3 cm on the 10-cm visual analogue scale. per group to have 80% power to detect this difference as significant with an alpha of 5%. To allow for drop outs, we No adverse events were reported in either group. increased the total sample size to 80 participants. Discussion All participants were analysed according to their group allocation, ie, using an intention-to-treat analysis. For Our results showed that six weeks of nightly stretching of each outcome, the difference between the experimental the calf and hamstring muscles significantly reduced the and control groups in the change from baseline to post- frequency and severity of nocturnal leg cramps in older intervention was calculated as a mean difference. Statistical people. The best estimate of the average effect of stretching significance was set at p < 0.05, so these mean differences on the frequency of cramps was a reduction of about one are presented with 95% confidence intervals. cramp per night. Given that participants had an average of approximately three cramps per night at the beginning Results of the study, this is a substantial effect and approximately equal to the effect we nominated as worthwhile. Since the Flow of participants through the trial stretches are quick and simple to perform, some patients may even consider the weakest effect suggested by the limit In total, 119 people responded to the study advertisement. of the confidence interval (a reduction of 0.6 cramps per Telephone screening of these respondents identified 39 night) to be worthwhile. as ineligible or unwilling to participate. The remaining 80 participants were randomised into the experimental The stretches reduced the severity of the pain that occurred or control group and completed the study, with 40 being with the nocturnal leg cramps by 1.3 cm on a 10-cm visual allocated to each group. The flow of participants through analogue scale. We do not know the smallest effect on the the trial and reasons for exclusion are presented in Figure severity of the cramps that patients typically feel would 2. The baseline characteristics of the participants are make the stretches worthwhile. In other research using the presented in Table 1 and the first two columns of Table 2. 10-cm visual analogue scale for pain, a change score of 2 cm has been proposed in chronic low back pain patients Compliance with trial method (Ostelo and de Vet 2005). An effect of this magnitude was not achieved in our study within the 6-week intervention All participants completed their diary cards at Weeks 0 period. However, the confidence interval around this result and 6 and reported that they maintained their usual daily is reasonably narrow. Therefore patients can be advised that activities throughout the study. No participants used quinine the average effect of the stretches is to reduce the severity for the duration of the study. of the pain by 1.3 cm on the 10-cm scale (or close to this value). Patients can then decide for themselves whether this Effect of intervention effect – in addition to the reduced frequency of the cramps – makes the stretches worth doing. Group data for all outcomes are presented in Table 2. Individual data are presented in Table 3 (see eAddenda for Table 3). The frequency of nocturnal leg cramps reduced in Journal of Physiotherapy 2012 Vol. 58 – © Australian Physiotherapy Association 2012. Open access under CC BY-NC-ND license. 21
Research In this trial, stretching was performed at home and was References patient-centred. This facilitated performance of the intervention, which may have aided adherence with the Abdulla AJ, Jones PW, Pearce VR (1999) Leg cramps in stretches and increased the effectiveness of the intervention. the elderly: prevalence, drug and disease associations. In this setting, however, correct execution of the stretching International Journal of Clinical Practice 53: 494–496. technique was not closely monitored. All the participants in the experimental group did two exercises, regardless of Adair G (1984) The Hawthorne effect: a reconsideration of the whether the cramp was located in the hamstrings or calf. methodological artefact. Journal of Applied Psychology 2: Greater effects may perhaps be achievable if stretches were 334–345. to be targeted at the site(s) of each participant’s cramps. This could be investigated in a future trial. Anonymous (2007) Nocturnal leg cramps and quinine therapy. Australian Journal of Pharmacy 88: 68. The results of this study are consistent with those of the uncontrolled study by Daniell and colleagues (1979), Aronson JK (2006) Meyler’s side effects of drugs: the which suggested that stretching exercises were effective international encyclopedia of adverse drug reactions and in preventing the occurrence of nocturnal leg cramps. interactions (15th edn). Amsterdam: Elsevier. Conversely, our results differ from those of Coppin and colleagues (2005), who concluded that a stretching Butler JV, Mulkerrin EC, O’Keeffe ST (2002) Nocturnal leg intervention failed to significantly relieve the intensity cramps in older people. Postgraduate Medical Journal 78: and frequency of nocturnal leg cramps. Some details of 596–598. that stretching regimen, such as the exact time of day at which stretching was performed, remain unclear. However, Coppin RJ, Wicke DM, Little PS (2005) Managing nocturnal leg the different result in our study may be attributable to cramps–calf-stretching exercises and cessation of quinine differences in the time of day, the number of repetitions treatment: a factorial randomized controlled trial. British of the stretch, and the different eligible populations (users Journal of General Practice 55: 186–191. versus non-users of quinine). Daniell HW (1979) Simple cure for nocturnal leg cramps. New One possible limitation of this study is that the test results England Journal of Medicine 301: 216. were obtained using self-reported ‘measurements’ in a daily diary. Progress in the control group might be due to the El-Tawil S, Al Musa T, Valli H, Lunn MPT, El-Tawil T, Weber Hawthorne effect (Adair 1984). In addition, selection bias M (2010) Quinine for muscle cramps. Cochrane Database may have affected our results due to the preferences of the of Systematic Reviews, Issue 12. Art. No.: CD005044. DOI: participants to participate in this study. Difference in the '&$'&&(%'*,+'.+.$9:&&+&**$fkX($ ages of both groups also may have caused bias, which could have been reduced through a pre-stratification procedure. Hirai M (2000) Prevalence and characteristics of muscle However, the study design incorporated several features to cramps in patients with varicose veins. Vasa 29: 269–273. reduce the risk of bias in the results, the necessary sample size was calculated and obtained, and no dropouts occurred Inan-Arslan N, Knuistingh Neven A, Eekhof JAH (2006) during the follow-up. Nachtelijke kuitkrampen. Huisarts Wet 49: 215–217. Despite some potential limitations, the results of the study Jones CJ, Rikli RE, Beam WC (2000) A 30-s chair-stand test are promising for use in physical therapy settings; even to measure lower body strength in community-residing older though it only considered the context of the increasing adults. Journal of Aging & Physical Activity 8: 85. number of older adults with nocturnal leg cramps, a physical therapy consultation might be an effective option. Kanaan N, Sawaya R (2001) Nocturnal leg cramps: Clinically More evidence is needed to validate the long-term effects of mysterious and painful–but manageable. Geriatrics 56: 39– stretching on nocturnal leg cramps. Q 42. Footnotes: aDigiwalker SW-200, Yamax, Tokyo, Japan. Khassawneh BY (2005) Periodic limb movement disorder. In, Lee-Chiong T (Ed) Sleep: A Comprehensive Handbook. eAddenda: Table 3 available at jop.physiotherapy.asn.au Hoboken: Wiley. Ethics: The University Medical Center Groningen Ethics Monderer RS, Wu WP, Thorpy MJ (2010) Nocturnal leg cramps. Committee(s) approved this study. All participants gave Current Neurology and Neuroscience Reports 10: 53–59. written informed consent before data collection began. Norris SP, Stevens B, Pfefferbaum KF, Wyche RL (2008) Acknowledgements: The authors thank the participants Community resilience as a metaphor, theory, set of and the physiotherapists who participated in the study. capacities, and strategy for disaster readiness. American Journal of Community Psychology 41: 127–150. Competing interests: None declared. Ostelo RW, de Vet HW (2005) Clinically important outcomes Correspondence: JM Hallegraeff, Research Group in in low back pain. Best Practice & Research Clinical Health Care and Nursing, Hanze University, Groningen, Rheumatology 19: 593–607. The Netherlands. Email: [email protected] Schneider PL, Crouter SE, Lukajic O, Bassett DR, Jr. (2003) Accuracy and reliability of 10 pedometers for measuring steps over a 400-m walk. Medicine and Science in Sports and Exercise 35: 1779–1784. Sontag SJ, Wanner JN (1988) The cause of leg cramps and knee pains: a hypothesis and effective treatment. Medical Hypothesis 25: 35–41. Stewart RB, Moore MT, Marks RG (1993) Nocturnal leg cramps in an ambulatory elderly population: An evaluation of risk factors. Journal of Geriatric Drug Therapy 7: 23–46. van Kan VH, Jansen PH, Tuinte C, Smits P, Verbeek AL (2000) Hydroquinine pharmacokinetics after oral administration in adult patients with muscle cramps. European Journal of Clinical Pharmacology 56: 263–267. Vetrugno R, D’Angelo R, Montagna P (2007) Periodic limb movements in sleep and periodic limb movement disorder. Neurological Sciences 28: S9–S14. 22 Journal of Physiotherapy 2012 Vol. 58 – © Australian Physiotherapy Association 2012. Open access under CC BY-NC-ND license.
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