N/A
N=317
Fibromyalgia Integrative Training for Adolescents With Juvenile Fibromyalgia
Fibromyalgia · Myofascial Pain Syndrome · Muscular Diseases · Musculoskeletal Disease · Rheumatic Diseases
Bottom Line
View on ClinicalTrials.gov: NCT03268421 ↗Enrolled (actual)
317
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcome: Primary: Functional Disability Inventory — 25.78; 24.10; 25.96; 21.83 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Fibromyalgia Integrative Training for Teens (Behavioral); Cognitive Behavioral Therapy (Behavioral); Graded Aerobic Exercise (Behavioral)
- Age
- Pediatric, Adult · 12+ yrs
- Sex
- All
- Sponsor
- Children's Hospital Medical Center, Cincinnati
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Functional Disability Inventory |
25.78; 24.10; 25.96; 21.83; 21.65; 24.70 | — |
| SECONDARY Pain Intenstiy |
5.71; 5.93; 5.88; 5.29; 5.41; 5.44 | — |
Summary
This study evaluated whether Fibromyalgia Integrative Training program for Teens (FIT Teens), a combined cognitive behavioral therapy and neuromuscular exercise training program is more effective in reducing disability in adolescents with Juvenile Fibromyalgia compared to cognitive behavioral therapy (CBT) alone or a graded aerobic exercise (GAE) program alone. One third of participants received the FIT Teens training; one third received CBT training; and one third of participants received the GAE training.
Eligibility Criteria
Inclusion Criteria
- Juvenile Fibromyalgia diagnosis by pediatric rheumatologist or pain physician and confirmed by 2010 American College of Rheumatology (ACR) criteria modified for pediatric use
- Functional Disability Score ≥ 13, indicating at least moderate disability
- Average pain intensity in the past week ≥ 4 on a 0 -10 cm Visual Analog Scale
- Stable medications prior to enrollment
Exclusion Criteria
- Comorbid rheumatic disease (e.g. juvenile arthritis, systemic lupus erythematous)
- Untreated major psychiatric diagnoses (e.g. bipolar disorder, psychoses, symptoms of major depression) or documented developmental delay
- Any medical condition determined by their physician to be a contraindication for physical exercise
- Taking opioid pain medication
Data sourced from ClinicalTrials.gov (NCT03268421). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.