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Physiotherapy for sleep disturbance in people with chronic low back pain: results of a feasibility randomized controlled trial |
Eadie J, van de Water ATM, Lonsdale C, Tully MA, van Mechelen W, Boreham CAG, Daly L, McDonough SM, Hurley DA |
Archives of Physical Medicine and Rehabilitation 2013 Nov;94(11):2083-2092 |
clinical trial |
7/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: No; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
OBJECTIVE: To determine the feasibility of a randomized controlled trial investigating the effectiveness of physiotherapy for sleep disturbance in chronic low back pain (>= 12 weeks; CLBP). DESIGN: Randomized controlled trial with evaluations at baseline, 3 and 6 months. SETTING: Outpatient physiotherapy department in academic teaching hospital. PARTICIPANTS: Participants with CLBP were randomly assigned to a walking programme (WP n = 20: mean age +/- SD 46.4 +/- 13.8y), supervised exercise class (SEC n = 20: mean age +/- SD 41.3 +/- 11.9y) or usual physiotherapy (UP n = 20: mean age +/- SD 47.1 +/- 14.3y). The 3 month evaluation was completed by 44 participants (73%), and 42 (70%) completed the 6 month evaluation. INTERVENTIONS: Participants received a physiotherapy delivered 8 week WP, an 8 week group SEC (one class per week) or one-to-one UP (advice, manual therapy and exercise). MAIN OUTCOME MEASURES: Sleep was assessed by the self-reported Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI), Pittsburgh Sleep Diary, and objective actigraphy. RESULTS: The groups were comparable at baseline. The majority (95%, n = 57) of participants had sleep disturbance. The acceptability of actigraphy was excellent at baseline (58/60 participants), but dropped at three months (n = 26/44). There were improvements on the PSQI and ISI in all groups at 3 and 6 months, with predominantly medium effect sizes (Cohen's d = 0.2 to 0.5). CONCLUSIONS: The high prevalence of sleep disturbance indicated the feasibility of good recruitment in future trials. The PSQI would be a suitable screening tool and outcome measure, alongside an objective non-obtrusive sleep outcome measure. The effectiveness of physiotherapy for sleep disturbance in CLBP warrants investigation in a fully powered randomized controlled trial.
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