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Multicomponent interdisciplinary group intervention for self-management of fibromyalgia: a mixed-methods randomized controlled trial
Bourgault P, Lacasse A, Marchand S, Courtemanche-Harel R, Charest J, Gaumond I, de Souza JB, Choiniere M
PLoS ONE 2015 May;10(5):e0126324
clinical trial
5/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; 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*

BACKGROUND: This study evaluated the efficacy of the PASSAGE program, a structured multicomponent interdisciplinary group intervention for the self-management of FMS. METHODS: A mixed-methods randomized controlled trial (intervention (INT) versus waitlist (WL)) was conducted with patients suffering from FMS. Data were collected at baseline (T0), at the end of the intervention (T1), and 3 months later (T2). The primary outcome was change in pain intensity (0 to 10). Secondary outcomes were fibromyalgia severity, pain interference, sleep quality, pain coping strategies, depression, health-related quality of life, patient global impression of change (PGIC), and perceived pain relief. Qualitative group interviews with a subset of patients were also conducted. Complete data from T0 to T2 were available for 43 patients. RESULTS: The intervention had a statistically significant impact on the three PGIC measures. At the end of the PASSAGE program, the percentages of patients who perceived overall improvement in their pain levels, functioning and quality of life were significantly higher in the INT group (73%, 55%, 77% respectively) than in the WL group (8%, 12%, 20%). The same differences were observed 3 months post-intervention (intervention group 62%, 43%, 38% versus waitlist group 13%, 13%, 9%). The proportion of patients who reported > 50% pain relief was also significantly higher in the INT group at the end of the intervention (36% versus 12%) and 3 months post-intervention (33% versus 4%). Results of the qualitative analysis were in line with the quantitative findings regarding the efficacy of the intervention. The improvement, however, was not reflected in the primary outcome and other secondary outcome measures. CONCLUSION: The PASSAGE program was effective in helping FMS patients gain a sense of control over their symptoms. We suggest including PGIC in future clinical trials on FMS as they appear to capture important aspects of the patients' experience. TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number Register ISRCTN14526380.

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