Fibromyalgia Integrative Training for Teens
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Juvenile Fibromyalgia
- Sponsor
- Children's Hospital Medical Center, Cincinnati
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Average Pain Intensity
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief 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).
Detailed Description
CBT has been found to have beneficial effects on improving coping among adolescents with JFM and increasing patients' ability to engage in daily activities. The purpose of this study is to evaluate whether CBT can be enhanced with specialized neuromuscular training, in the new fibromyalgia integrative training (FIT Teens) intervention, to produce stronger pain reduction than CBT alone. Neuromuscular training originates from the field of pediatric sports medicine and has been successfully used for injury prevention but has never before been utilized for pain management in JFM. This type of training emphasizes education and proper training in fundamental movement skills prior to the initiation of more vigorous physical activity and exercise. It is expected that the neuromuscular training integrated with established CBT techniques will enhance patients' ability to engage in exercise and to achieve better JFM pain control. Adolescents with JFM will be randomly assigned to receive either the 8-week FIT Teens intervention or an 8-week CBT program with assessments at baseline, post-treatment and 3-month follow-up.
Investigators
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
Outcomes
Primary Outcomes
Average Pain Intensity
Time Frame: Baseline, post-treatment and 3-month follow-up
Average pain intensity in the past week marked on a paper-pencil Visual Analog Scale (Min = 0 {no pain} to Max = 10 {pain as bad as it can be}). Lower scores mean better outcomes.
Secondary Outcomes
- Depressive Symptoms(Baseline, Post-treatment, 3-month follow-up)
- Functional Disability(Baseline, post-treatment and 3-month follow-up)