At a glance
ClinicalIndex Comparison Record- ✓Diagnosis of juvenile primary fibromyalgia syndrome (JPFS) based on widespread pain for over 3 months, at least 5 tender points, and associated features (sleep difficulty, fatigue, 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
- ✕Other chronic rheumatic diseases such as juvenile rheumatoid arthritis or lupus
- ✕Significant developmental delay or impairments including autism, cerebral palsy, or intellectual disability
- ✕Current or lifetime psychiatric diagnosis meeting DSM-IV criteria for panic disorder, bipolar disorder, major depressive disorder, or psychosis
- ✕Chronic opioid medications for fibromyalgia pain treatment
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized Clinical Trial in Juvenile Fibromyalgia
In Brief
A Phase 3 clinical trial evaluating Coping Skills Training and Education for Fibromyalgia. Completed, enrolled 114 participants across 3 sites.
Detailed 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.
Study Details
Timeline
Interventions
8 weekly sessions of behavioral treatment
8 weekly sessions of fibromyalgia education