Juvenile Fibromyalgia Clinical Trial
— FIT TeensOfficial title:
Fibromyalgia Integrative Training for Teens
Verified date | February 2022 |
Source | Children's Hospital Medical Center, Cincinnati |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 40 |
Est. completion date | December 2016 |
Est. primary completion date | July 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years to 18 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital Medical Center, Cincinnati | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Average Pain Intensity | 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. | Baseline, post-treatment and 3-month follow-up | |
Secondary | Functional Disability | Validated 15-item patient-report measure of difficulties in physical, social and recreational activities in the past 2 weeks (score Min = 0, Max = 60; Lower score means less disability/better outcome) | Baseline, post-treatment and 3-month follow-up | |
Secondary | Depressive Symptoms | Children's Depression Inventory: a 27-item validated patient-report measure of depressive symptoms in the past 2 weeks (scores 0 = no depressive symptoms to 54 = most severe symptoms; lower score means less depression/better outcomes) | Baseline, Post-treatment, 3-month follow-up |