• Patricia Bourgault, Anaïs Lacasse, Serge Marchand, Roxanne Courtemanche-Harel, Jacques Charest, Isabelle Gaumond, Barcellos de Souza Juliana J Centre de recherche clinique Étienne-Le Bel du Centre hospitalier universitaire de Sherbrooke, Sherbrooke, QC, Canada., and Manon Choinière.
• École des sciences infirmières, Faculté de médecine et des sciences de la santé, Université de Sherbrooke, Sherbrooke, QC, Canada; Centre de recherche clinique Étienne-Le Bel du Centre hospitalier universitaire de Sherbrooke, Sherbrooke, QC, Canada; Centre de recherche du Centre hospitalier de l'Université de Montréal (CRCHUM), Montréal, QC, Canada.
• Plos One. 2015 Jan 1; 10 (5): e0126324.

BackgroundThis study evaluated the efficacy of the PASSAGE Program, a structured multicomponent interdisciplinary group intervention for the self-management of FMS.MethodsA mixed-methods randomized controlled trial (intervention (INT) vs. 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 (0-10). 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.ResultsThe 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% vs 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% vs 12%) and 3 months post-intervention (33% vs 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.ConclusionThe 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 RegistrationInternational Standard Randomized Controlled Trial Number Register ISRCTN14526380.

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