Multicenter randomized controlled trial of cognitive-behavioral, exercise-based, and combined interventions for juvenile fibromyalgia

Juvenile fibromyalgia (JFM) is a complex and disabling chronic pain condition for which treatment options are limited. The objective of this randomized controlled trial was to compare the relative efficacy of 3 group-based interventions: cognitive-behavioral therapy (CBT) alone, graded aerobic exercise (GAE) alone, or CBT combined with specialized neuromuscular exercise (Fibromyalgia Integrative Training FIT Teens), in reducing pain-related disability for adolescents with JFM. Patients with JFM (ages 12-17) who experienced moderate-to-severe pain and pain-related disability were eligible. A total of 317 adolescents (86.4% girls, 84.2% White, mean age 15.8 years) were randomized to receive 8 weeks (16 sessions) of CBT (N = 110), GAE (N = 104), or FIT Teens (N = 103), followed by 4 booster sessions. Our primary hypothesis that the FIT Teens intervention would be superior to CBT or GAE was not supported. Rather, participants in all treatments showed significant reduction in disability with no differences between groups at the 3-month primary endpoint (main effect estimate = -3·94 95% CI: -6·62 to -1·26) and at 6-, 9-, and 12-month follow-up (main effect estimate = -4·52 95% CI: -7·35 to -1·68; -4·21 95% CI: -7·13 to -1·29; and -4·76 95% CI: -7·84 to -1·68, respectively). Pain intensity was significantly improved at 9- and 12-month follow-up. Although the overall magnitude of improvement in disability was small, approximately 1 in 4 patients in the FIT and CBT groups had clinically remarkable improvement. Cognitive-behavioral and exercise-based treatments are promising for the management of JFM. Further research is needed to examine the characteristics of treatment responders and the mechanisms of improvement.