Multicenter randomized controlled trial of cognitive-behavioral, exercise-based, and combined interventions for juvenile fibromyalgia, 2025, Kashikar-

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

Kashikar-Zuck, Susmita; Williams, Sara E.; Ittenbach, Richard F.; Peugh, James; Thomas, Staci; Lynch-Jordan, Anne M.; Kirschman, Megan; Ting, Tracy V.; Connelly, Mark; Zempsky, William; Williams, Amy E.; Ardoin, Stacy P.; Logan, Deirdre E.; Wakefield, Emily O.; Goldstein-Leever, Alana; Goldschneider, Kenneth; Nelson, Sarah; Stinson, Jennifer N.; Myer, Gregory D.

Abstract
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.

Web | DOI | Pain
 
The benefits seen from exercise for FM has been on par with what you’d get from bias alone. So this means that all of the interventions are useless, as expected.
 
"Treatment options are limited", so let's compare the same junk that's been trialled hundreds of times, which itself has been trialled many times? Yeah, makes sense when you don't think about it. It's like a worse version of "there are n protocols for x, let's make another one, now there are n+1 protocols" except there are still n protocols and you still don't have any options.
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.
And their conclusion is that it's all good, since it's all just as useless. Good grief. There is clearly something missing when so many smart people keep doing the same nonsense without ever thinking.

Notable that this is a pretty big trial. Lots of participants and lots of researchers. They find nothing, and still conclude that it's promising and should be done again. This is an insane way of doing anything.
 
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