This multicenter randomized controlled trial enrolled 317 adolescents (86.4% girls, 84.2% White, mean age 15.8 years) with juvenile fibromyalgia experiencing moderate-to-severe pain and disability. Participants were assigned to cognitive-behavioral therapy (CBT) alone, graded aerobic exercise (GAE) alone, or Fibromyalgia Integrative Training (FIT) Teens, which combines CBT with specialized neuromuscular exercise.
All three interventions significantly reduced pain-related disability compared to baseline, with no statistically significant differences between groups at any follow-up point. The main effect estimates for disability reduction were -3.94 [95% CI: -6.62 to -1.26] at 3 months, -4.52 [95% CI: -7.35 to -1.68] at 6 months, -4.21 [95% CI: -7.13 to -1.29] at 9 months, and -4.76 [95% CI: -7.84 to -1.68] at 12 months. Pain intensity also improved significantly at 9- and 12-month follow-ups, though specific effect sizes were not reported. Approximately 1 in 4 patients in the FIT and CBT groups achieved clinically remarkable improvement.
Safety and tolerability data were not reported. The study's primary hypothesis that FIT Teens would be superior to either component alone was not supported. The overall magnitude of improvement in disability was small, though statistically significant. These findings suggest that both cognitive-behavioral and exercise-based approaches are active treatments for juvenile fibromyalgia, but clinicians should not expect one approach to be clearly superior to others.
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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.