A randomized clinical trial comparing fitness and biofeedback training versus basic treatment in patients with fibromyalgia

OBJECTIVE: To compare the therapeutic effects of physical fitness training or biofeedback training with the results of usual care in patients with fibromyalgia (FM). METHODS: One hundred forty-three female patients with FM (American College of Rheumatology criteria) were randomized into 3 groups: a fitness program (n = 58), biofeedback training (n = 56), or controls (n = 29). Half the patients in the active treatment groups also received an educational program aimed at improving compliance. Assessments were done at baseline and after 24 weeks. The primary outcome was pain [visual analog scale (VAS)]. Other endpoints were the number of tender points, total myalgic score (dolorimetry), physical fitness, functional ability (Arthritis Impact Measurement Scale and Sickness Impact Profile), psychological distress (Symptom Checklist-90-Revised), patient global assessment (5 point scale), and general fatigue (VAS). RESULTS: Baseline scores were similar in all 3 groups. Altogether 25 (17.5%) patients dropped out; they were similarly distributed over all groups: 14 patients after randomization and 11 (8%) during the study. A true high impact level for fitness training was not attained by any patient. After treatment, no significant differences in change scores of any outcome were found between the groups (ANOVA, p > 0.05). All outcome measures showed large variations intra- and interindividually. The educational program did not result in higher compliance with training sessions (62% vs 71%). Analysis of the subgroup of subjects with a high attendance rate (> 67%) also showed no improvement. CONCLUSION: In terms of training intensity and maximal heart rates, the high impact fitness intervention had a low impact benefit. Therefore effectiveness of high impact physical fitness training cannot be demonstrated. Thus compared to usual care, the fitness training (i.e., low impact) and biofeedback training had no clear beneficial effects on objective or subjective patient outcomes in patients with FM.