Multi-site Randomized Clinical Trial of FIT Teens for Juvenile Fibromyalgia
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Fibromyalgia
- Sponsor
- Children's Hospital Medical Center, Cincinnati
- Enrollment
- 389
- Locations
- 7
- Primary Endpoint
- Functional Disability Inventory
- Status
- Completed
- Last Updated
- last year
Overview
Brief 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.
Detailed Description
Juvenile-onset fibromyalgia (JFM) is a chronic, debilitating pain condition that typically persists into adulthood for the majority of patients. Whereas medications offer limited and short-term symptom relief for JFM, our research group has demonstrated that cognitive-behavioral therapy (CBT) is safe, effective and durable in reducing functional disability and depressive symptoms in adolescents with this condition. However, 60% of patients receiving CBT did not show clinically significant improvement in functional disability, and pain levels remained in the moderate range despite being reduced overall. Our multidisciplinary team of experts in Behavioral Medicine, Rheumatology and Exercise Science has developed and tested the feasibility of a new Fibromyalgia Integrative Training program for Teens (FIT Teens), which enhances the established CBT intervention with a novel neuromuscular exercise training program derived from evidence-based pediatric injury prevention research. Pilot testing showed excellent patient engagement, no adverse effects and very promising early results indicating this treatment to have even stronger effects on disability and pain outcomes than CBT alone. This trial evaluated whether the FIT Teens intervention is more effective than CBT alone or graded aerobic exercise alone and whether treatment effects are sustainable over 1 year follow-up.
Investigators
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
Outcomes
Primary Outcomes
Functional Disability Inventory
Time Frame: Baseline to 3 month follow up (primary endpoint) and 6, 9 and 12 month follow-up
Functional Disability Inventory (FDI) is a validated 15-item self-report measure, developed to assess perceived difficulty in the performance of daily activities in home, school, recreational, and social domains due to pain. Total sum scores are calculated and range from 0 - 60, with higher scores indicating greater functional disability. Clinical reference points are: No/Minimal disability (0 to 12), Mild disability (13 to 20), Moderate disability (21 to 29) and Severe disability (≥30). For this primary outcome, data from this questionnaire was used to compare baseline response to 3 month follow up to examine whether a reduction in disability occurs. The main outcome measure for this comparison is the difference in baseline and primary endpoint (3 month) FDI scores for each of the three interventions (FIT Teens, CBT, and GAE).
Secondary Outcomes
- Pain Intenstiy(Baseline to 3 month follow up (primary endpoint) and 6, 9 and 12 month follow-up)