Multicomponent Interdisciplinary Group Intervention for Self-Management of Fibromyalgia: A Mixed-Methods Randomized Controlled Trial

• Published in: PloS one Vol. 10; no. 5; p. e0126324
• Main Authors: Bourgault, Patricia, Lacasse, Anaïs, Marchand, Serge, Courtemanche-Harel, Roxanne, Charest, Jacques, Gaumond, Isabelle, Barcellos de Souza, Juliana, Choinière, Manon
• Format: Journal Article
• Language: English
• Published: United States Public Library of Science 15.05.2015; Public Library of Science (PLoS)
• Subjects: Adolescent; Adult; Aged; Care and treatment; Clinical medicine; Clinical trials; Complications and side effects; Control methods; Depression (Mood disorder); Diabetic neuropathy; Exercise; Female; Fibromyalgia; Fibromyalgia - physiopathology; Humans; Interdisciplinary aspects; International standards; Intervention; Male; Medical research; Mental depression; Methods; Middle Aged; Mixed methods research; Pain; Pain Measurement; Patients; Physical fitness; Physical therapy; Qualitative analysis; Qualitative research; Quality of Life; Randomization; Rheumatology; Risk factors; Self care (Health); Self Care - methods; Sleep; Statistical analysis; Studies; Systematic review; Treatment Outcome; Womens health; Young Adult; Canada
• ISSN: 1932-6203; 1932-6203
• DOI: 10.1371/journal.pone.0126324

This study evaluated the efficacy of the PASSAGE Program, a structured multicomponent interdisciplinary group intervention for the self-management of FMS. A 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. 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% 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. 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. International Standard Randomized Controlled Trial Number Register ISRCTN14526380.