Multicomponent interdisciplinary group intervention for self-management of fibromyalgia: a mixed-methods randomized controlled trial

PLoS One. 2015 May 15;10(5):e0126324. doi: 10.1371/journal.pone.0126324. eCollection 2015.

Abstract

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) 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.

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% 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.

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.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Female
  • Fibromyalgia / physiopathology*
  • Humans
  • Male
  • Middle Aged
  • Pain Measurement
  • Quality of Life
  • Self Care / methods*
  • Treatment Outcome
  • Young Adult

Associated data

  • ISRCTN/ISRCTN14526380

Grants and funding

MC, PB and SM received a team research grant—Community Alliances for Health Research and Knowledge Exchange in Pain—of the Canadian Institutes of Health Research in partnership with AstraZeneca Canada Inc (Grant # 86787) (http://www.cihr-irsc.gc.ca) to carry out the study. MC and PB also received an unrestricted research grant from Pfizer Canada Inc. (http://www.pfizer.ca) for the same research project. During the study, PB was the recipient of a postdoctoral research award from the Quebec Rehabilitation Research Network (http://www.repar.ca) which is itself funded by the Fonds de la recherche en santé du Québec (http:www.frqs.gouv.qc.ca), and AL was the recipient of a postdoctoral research award from the Fonds de la recherche en santé du Québec (http:www.frqs.gouv.qc.ca). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.