Community patient education and exercise for people with fibromyalgia: a parallel group randomised controlled trial

OBJECTIVE: To evaluate the effects of a community patient education -exercise programme, using a cognitive-behavioural approach, for people with fibromyalgia. DESIGN: A randomized, parallel group trial with assessments at 0, 4 and 8 months. SETTING: Community leisure centres. SUBJECTS: People with fibromyalgia (n=183) attending a rheumatology outpatient department at a large district general hospital. INTERVENTIONS: Participants were randomized to a patient education-exercise group (n=97) or relaxation (attention control) group (n=86). MAIN MEASURES: The Fibromyalgia Impact Questionnaire (0-80; lower score means better health). Secondary outcomes included: the Arthritis Self-Efficacy Scale(pain and other symptoms subscales: 1 -10 scale; higher scores mean greater self-efficacy) and self-reported improvement. RESULTS: Fifty participants withdrew or were unable to attend and 133 completed and returned baseline questionnaires: patient education group (n=71); relaxation group (n=62); 120/133 participants were women. Average age was 48.53 (SD 10.89) years. Follow-up ranged between 73 and 82% of questionnaires returned. At four months, there was a difference in average changes in total Fibromyalgia Impact Questionnaire scores between the two groups: patient education group--3.38 (SD 9.35); relaxation group 0.3 (SD 8.85); P=0.02. Arthritis Self-Efficacy Scale scores were significantly higher in the patient education group: pain 0.59 (SD 1.45)compared to the relaxation group's--0.12 (SD 1.22); P=0.003; other symptoms (patient education group 0.72 (SD 1.33); relaxation group 0.03 (SD 1.16); P=0.002). At eight months these differences were no longer apparent. Forty-seven per cent in the patient education group self-reported improvement compared with 13% in the relaxation group (chi2=13.65; P=0.0001). CONCLUSION: Short-term improvements resulted from the education -exercise programme but were not sustained. Appropriate selection may improve efficacy