Randomized clinical trial of Fibromyalgia Integrative Training (FIT teens) for adolescents with juvenile fibromyalgia - Study design and protocol.
Cognitive behavioral therapy
Juvenile fibromyalgia
Neuromuscular training
Pediatric chronic pain
RCT- randomized clinical trial
Journal
Contemporary clinical trials
ISSN: 1559-2030
Titre abrégé: Contemp Clin Trials
Pays: United States
ID NLM: 101242342
Informations de publication
Date de publication:
04 2021
04 2021
Historique:
received:
20
07
2020
revised:
27
01
2021
accepted:
09
02
2021
pubmed:
23
2
2021
medline:
28
9
2021
entrez:
22
2
2021
Statut:
ppublish
Résumé
Juvenile-onset fibromyalgia (JFM) is a chronic debilitating pain condition that negatively impacts physical, social and academic functioning. Cognitive-behavioral therapy (CBT) is beneficial in reducing functional disability among adolescents with JFM but has only a modest impact on pain reduction and does not improve physical exercise participation. This randomized controlled trial (RCT) aims to test whether a novel intervention that combines CBT with specialized neuromuscular exercise training (the Fibromyalgia Integrative Training program for Teens "FIT Teens") is superior to CBT alone or a graded aerobic exercise (GAE) program. This 3-arm multi-site RCT will examine the efficacy of the FIT Teens intervention in reducing functional disability (primary outcome) and pain intensity (secondary outcome), relative to CBT or GAE. All interventions are 8-weeks (16 sessions) in duration and are delivered in small groups of 4-6 adolescents with JFM. A total of 420 participants are anticipated to be enrolled across seven sites with approximately equal allocation to each treatment arm. Functional disability and average pain intensity in the past week will be assessed at baseline, post-treatment and at 3-, 6-, 9- and 12-month follow-up. The 3-month follow-up is the primary endpoint to evaluate treatment efficacy; longitudinal assessments will determine maintenance of treatment gains. Changes in coping, fear of movement, biomechanical changes and physical fitness will also be evaluated. This multi-site RCT is designed to evaluate whether the combined FIT Teens intervention will have significantly greater effects on disability and pain reduction than CBT or GAE alone for youth with JFM. Clinical trials.gov registration: NCT03268421.
Identifiants
pubmed: 33618033
pii: S1551-7144(21)00057-4
doi: 10.1016/j.cct.2021.106321
pmc: PMC8089039
mid: NIHMS1677964
pii:
doi:
Banques de données
ClinicalTrials.gov
['NCT03268421']
Types de publication
Clinical Trial Protocol
Journal Article
Research Support, N.I.H., Extramural
Langues
eng
Sous-ensembles de citation
IM
Pagination
106321Subventions
Organisme : NIAMS NIH HHS
ID : R01 AR070474
Pays : United States
Organisme : NIAMS NIH HHS
ID : U34 AR067978
Pays : United States
Informations de copyright
Copyright © 2021 Elsevier Inc. All rights reserved.
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