N/A
N=40
Fibromyalgia Integrative Training for Teens
Juvenile Fibromyalgia
Bottom Line
View on ClinicalTrials.gov: NCT01981096 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Sep 2018
Primary outcome: Primary: Average Pain Intensity — 6.26; 6.41; 4.69; 6.38 units on a scale — p=.011
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Fibromyalgia integrative training (Behavioral); Cognitive Behavioral Therapy (Behavioral)
- Age
- Pediatric, Adult · 12+ yrs
- Sex
- All
- Sponsor
- Children's Hospital Medical Center, Cincinnati
- Primary completion
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Pain Intensity |
6.26; 6.41; 4.69; 6.38; 4.62; 6.55 | .011 sig |
| SECONDARY Functional Disability |
26.70; 24.45; 18.71; 23.95; 19.76; 22.68 | .055 |
| SECONDARY Depressive Symptoms |
15.8; 14.05; 11.71; 13.79; 11.35; 12.95 | — |
Summary
The purpose of this pilot randomized trial is to determine whether the fibromyalgia integrative training (FIT Teens) intervention is superior to cognitive-behavioral therapy (CBT) alone in reducing pain among adolescents with juvenile fibromyalgia (JFM).
Hypothesis 1: Patients in the FIT Teens group will show significantly greater reduction in pain intensity than the CBT group at final study assessment (i.e., 3-month follow up).
Hypothesis 2: Patients in both the FIT Teens and CBT groups will show significant reductions in functional disability and depressive symptoms at final study assessment (i.e., 3-month follow up).
Eligibility Criteria
Inclusion Criteria
- Males and females ages 12-18
- Juvenile fibromyalgia (JFM) diagnosed by a pediatric rheumatologist or pain physician using 2010 American College of Rheumatology (ACR) criteria and confirmation with a tender point exam of ≥ 11 of 18 tender points upon palpation
- 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
Exclusion Criteria
- Comorbid rheumatic disease (e.g., juvenile arthritis, systemic lupus erythematous)
- untreated major psychiatric diagnoses (e.g., major depression, bipolar disorder, psychoses)
- documented developmental delay
- any medical condition determined by their physician to be a contraindication for participation
- on stable medications for 4 weeks prior to enrollment
- currently in CBT or structured physical therapy program
Data sourced from ClinicalTrials.gov (NCT01981096). 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.