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Kashikar-Zuck S, Williams SE, Ittenbach RF, et al. Multicenter randomized controlled trial of cognitive-behavioral, exercise-based, and combined interventions for juvenile fibromyalgia. Pain. 2026 Apr 1;167(4):820-831. doi: 10.1097/j.pain.0000000000003840. Epub 2025 Nov 21. (Original study)
Abstract

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.

Ratings
Discipline Area Score
Physician 6 / 7
Rehab Clinician (OT/PT) 5 / 7
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Comments from MORE raters

Physician rater

CBT, graded aerobic exercise, and combined CBT with neuromuscular training result in significant and durable reductions in disability among adolescents with fibromyalgia. Pain relief is slow and modest, which underscores the importance of managing patient expectations. Despite more than half the participants taking antidepressants or NSAIDs, many still experienced moderate to severe symptoms, underscoring the limited potential of pharmacotherapy. No active treatment was more effective, raising questions about the impact of nonspecific factors influencing improvement. Key limitations are: a homogeneous sample that restricts generalizability; lack of a usual-care control group, preventing measurement of effect size beyond natural course; absence of data on cost-effectiveness or school functioning; and a clinically meaningful response rate of around 25%, indicating that most patients need more effective therapy options.

Physician rater

In adolescents with fibromyalgia, exercise-based interventions are both safe and effective, even when used alone. While reductions in pain tended to lag behind improvements in function, remote delivery methods proved just as effective, endorsing telerehabilitation approaches. Future directions include creating personalized treatment plans based on patient profiles and exploring shared therapeutic mechanisms, such as decreases in kinesiophobia and increases in self-efficacy, which may contribute to progress across different modalities. Additionally, studies on cost-effectiveness are necessary to inform resource allocation.
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