A randomised controlled trial to evaluate the effectiveness of a combined education and pool-based exercise programme and usual care in the treatment of patients with fibromyalgia syndrome

Abstract

Background: Fibromyalgia syndrome (FMS) is a chronic muscular pain syndrome, whose optimal management remains problematic. While pool-based exercise and patient education programmes are often used in FMS, the evidence for their efficacy is limited. Objective: The aim of this study was to determine the effectiveness of a 6-week combined pool-based exercise and education programme in addition to usual medical care versus usual medical care alone in the treatment of patients with FMS.Methods: A sample of convenience of 86 women (mean (SD) age = 49.6 (8.4)) with a diagnosis of FMS were recruited between June 2003 and August 2005. Participants were randomly allocated to “usual medical care” delivered by a Consultant Rheumatologist (n = 44) or the “intervention” group: i.e. a 6-week pool-based exercise and patient education programme (n = 42). The primary outcome measure was the Fibromyalgia Impact Questionnaire (FIQ). Secondary outcome measures included; total myalgic score, McGill Pain questionnaire, EuroQol health status questionnaire, Self-Efficacy for Managing Chronic Disease 6-item scale, and the 6-minute walk test. Participants were assessed at baseline and at three follow-up time points approximately 8 weeks (52/86, 60%), 20 weeks (44/86,51%) and 72 weeks post recruitment; the 72-week follow-up is ongoing and is not reported here. Between-group comparisons were performed with repeated measures analysis of covariance (with baseline scores as a covariate). Only a per protocol analysis is presented, protocol adherence for the intervention group (set at ≥ 50% of the intervention) was 71.4%.Results: The two groups were similar at baseline on demographics, clinical characteristics and outcome measures. At 8-weeks, mean (SD) FIQ scores were 78.6 (16.3) for the intervention group and 74.2 (23.0) for the usual care group. At 20-weeks the corresponding values were 76.8 (27.3) and 75.7 (22.8). Repeated measures ANCOVA found no significant between group differences across these time points for total FIQ score (p= 0.891), total myalgic score (p = 0.223), McGill pain rating index (p = 0.980) and present pain index (p = 0.980), EuroQol health state (p = 0.844), self-efficacy (p = 0.157), and the six-minute walk (p = 0.653). Conclusions: On the basis of per protocol analyses conducted at 20-weeks follow-up, the addition of a brief pool-based exercise and patient education programme to usual care does not offer superior benefit. The level of attrition in this study, however, limits more definitive conclusion from the current results. An intention-to-treat analysis, including the 72-week data, is planned.