JOURNAL ARTICLE
RANDOMIZED CONTROLLED TRIAL
RESEARCH SUPPORT, NON-U.S. GOV'T
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Physiotherapy for sleep disturbance in people with chronic low back pain: results of a feasibility randomized controlled trial.

OBJECTIVE: To determine the feasibility of a randomized controlled trial investigating the effectiveness of physiotherapy for sleep disturbance in chronic low back pain (CLBP) (≥12wks).

DESIGN: Randomized controlled trial with evaluations at baseline, 3 months, and 6 months.

SETTING: Outpatient physiotherapy department in an academic teaching hospital.

PARTICIPANTS: Participants with CLBP were randomly assigned to a walking program (n=20; mean age ± SD, 46.4±13.8y), supervised exercise class (n=20; mean age ± SD, 41.3±11.9y), or usual physiotherapy (n=20; mean age ± SD, 47.1±14.3y). The 3-month evaluation was completed by 44 participants (73%), and 42 (70%) participants completed the 6-month evaluation.

INTERVENTIONS: Participants received a physiotherapy-delivered 8-week walking program, an 8-week group supervised exercise class (1 class/wk), or 1-to-1 usual physiotherapy (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: Groups were comparable at baseline. Most (95%, n=57) of the participants had sleep disturbance. The acceptability of actigraphy was excellent at baseline (58 of 60 participants), but dropped at 3 months (26 of 44 participants). There were improvements on the PSQI and ISI in all groups at 3 and 6 months, with predominantly medium effect sizes (Cohen d=0.2-0.5).

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 nonobtrusive 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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