Background
Cognitive behaviour therapy (CBT) and exercise have been shown to result in improved outcomes for patients with fibromyalgia or chronic widespread pain (CWP), although whether they can deliver long-term benefit is unknown.
Objectives
To determine the long-term health effects of telephone-delivered CBT (tCBT), exercise, and combined treatments compared with treatment as usual (TAU) among patients with CWP.
Methods
The MUSICIAN Trial was a 2x2 factorial randomized controlled trial. Patients with CWP were identified from a screening survey sent to patients over 25 years old registered at 8 UK general practices. Eligible individuals were patients meeting the ACR definition of CWP, reporting disability, who had consulted their family physician in the last year and with no cause for their pain identified requiring alternative treatment. They were randomly assigned to one of four study arms: tCBT, exercise, combined tCBT and exercise, or TAU. Participants receiving tCBT had 8 telephone sessions provided weekly with a therapist involving techniques to manage pain, and had follow-up calls at 3 and 6 months. Patients in the exercise group followed a 6 month exercise program to improve cardiovascular fitness individually designed for them by a fitness instructor with whom they had monthly reviews. Patients assigned to combined treatment received both interventions concurrently, while the TAU group received usual care from their family physician. Participants were followed up at 30 months post-randomisation with a postal questionnaire or by telephone (in case of non-response). The primary outcome (change in health since entering study) was considered positive if a subject scored at least 6 (“I feel much better“) on a 7 point scale from 1 (“I feel very much worse “) to 7 (“I feel very much better “). Analysis was by logistic regression which adjusted for age, gender, centre and baseline predictors of outcome, to obtain measures of improvement in the active treatment groups compared to the TAU group. Results are reported as odds ratios (OR) and 95% confidence intervals (CI).
Results
A total of 442 persons entered the study and 361 persons provided responses at 30 months follow-up. Median age of participants was 57 years (interquartile range, 47-65). Of 94 respondents at 30 months follow-up in the TAU group, 12 (12.8%) reported a positive outcome, compared to 29 out of 82 in the tCBT group (35.4%), 27 out of 92 in the exercise group (29.4%) and, 29 out of 93 in the combined group (31.2%). Odds of improvement compared to TAU, after adjustment were: tCBT, OR 4.0 (95% CI, 1.8-8.7); exercise, 2.9 (1.4-6.3); combined, 3.5 (1.6-7.5). Odds of improvement were not significantly different across the three active treatment groups and specifically there was no added benefit of receiving both interventions.
Conclusions
A six month programme of tCBT and/or exercise for CWP is associated with long-term improvements in patient global assessment of health.
CORE (COnnecting REpositories)
CORE (COnnecting REpositories)
