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The benefit of adding a physiotherapy or occupational therapy intervention programme to a standardized group-based interdisciplinary rehabilitation programme for patients with chronic widespread pain: a randomized active-controlled non-blinded trial [with consumer summary]
Amris K, Bulow CV, Christensen R, Bandak E, Rasmussen MU, Danneskiold-Samsoe B, Waehrens EE
Clinical Rehabilitation 2019 Aug;33(8):1367-1381
clinical trial
5/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: No; Intention-to-treat analysis: No; 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 evaluate the benefit of adding occupational therapy or physiotherapy interventions to a standard rehabilitation programme targeted for chronic widespread pain. DESIGN: Randomized active-controlled non-blinded trial. SUBJECTS: Women with chronic widespread pain recruited in a tertiary outpatient clinic. METHODS: Participants were randomized to a two-week, group-based standard rehabilitation programme followed by 16 weeks of group-based occupational therapy (group BOT n = 43) or 16 weeks of group-based physiotherapy (group BPT n = 42). Group A only received the two-week rehabilitation programme acting as comparator (n = 96). OUTCOMES: Primary outcomes were the Assessment of Motor and Process Skills and Short Form-36 (SF36) Mental Component Summary score. RESULTS: Mean changes in motor and process ability measures were clinically and statistically insignificant and without differences across the three groups assessed 88 weeks from baseline. Motor ability measures -0.006 (95% confidence interval (CI) -0.244 to 0.233) in group BOT; -0.045 (95% CI -0.291 to 0.202) in group BPT; and -0.017 (95% CI -0.248 to 0.213) in group A, p = 0.903. Process ability measures 0.087 (95% CI -0.056 to 0.231) in group BOT; 0.075 (95% CI -0.075 to 0.226) in group BPT; and 0.072 (95% CI -0.067 to 0.211) in group A, p = 0.924. Mean changes in patient-reported outcomes were likewise small; clinically and statistically insignificant; and independent of group allocation, except for the SF36 mental component summary score in the BPT group: 8.58 (95% CI 1.75 to 15.41). CONCLUSION: Participants were on average stable in observation-based measures of functional ability and patient-reported outcomes, except in overall mental well-being, favouring the enhanced intervention. Efficacy of additional interventions on functional ability remains uncertain.

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