Phase 3
N=114
Coping Skills Training for Adolescents With Fibromyalgia
Fibromyalgia
Bottom Line
View on ClinicalTrials.gov: NCT00086047 ↗Enrolled (actual)
114
Serious AEs
0.0%
Results posted
Nov 2013
Primary outcome: Primary: Change in FDI (Functional Disability Inventory) Scores at End of Study — 21.4; 19.2; 13.4; 17.0 units on a 0-60 scale — p=0.007
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Coping Skills Training (Behavioral); Education (Behavioral)
- Age
- Pediatric, Adult · 11+ yrs
- Sex
- All
- Sponsor
- Children's Hospital Medical Center, Cincinnati
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in FDI (Functional Disability Inventory) Scores at End of Study |
21.4; 19.2; 13.4; 17.0 | 0.007 sig |
| SECONDARY Pain Intensity |
— | — |
| SECONDARY Depressive Symptoms |
— | — |
Summary
Juvenile fibromyalgia is a chronic pain condition that can cause considerable suffering and difficulty in an adolescent's day-to-day activities. The purpose of this study is to determine whether coping skills training, when combined with usual medical care, can reduce pain and disability in adolescents with fibromyalgia.
Study hypotheses: 1) Adolescents who receive coping skills training combined with their usual medical care will show significantly greater reductions in functional disability, pain, and depressive symptoms at the end of the acute treatment phase than adolescents who receive fibromyalgia education with their usual medical care. 2) Adolescents who receive coping skills training with their usual medical care will show significantly lower levels of functional disability, pain, and depressive symptoms at the end of a six-month maintenance phase than adolescents who receive fibromyalgia education with their usual medical care.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of JPFS based upon widespread pain for over 3 months, at least 5 tender points, and associated features such as sleep difficulty, fatigue, and abdominal discomfort
- Average pain intensity greater than 4 on the Visual Analog Scale
- Functional disability score greater than 7
- Stable medications for 8 weeks prior to study entry
Exclusion Criteria
- Other chronic rheumatic diseases, such as juvenile rheumatoid arthritis or lupus
- Significant developmental delay or impairments, such as autism, cerebral palsy, or mental retardation
- Present or lifetime psychiatric diagnosis that meets DSM-IV criteria for panic disorder, bipolar disorder, major depressive disorder, or psychosis
- Opioid medications are disallowed when used on an ongoing basis for treatment of fibromyalgia pain
Data sourced from ClinicalTrials.gov (NCT00086047). 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.