Fibromyalgia Clinical Trial
Official title:
Randomized Clinical Trial in Juvenile Fibromyalgia
Verified date | August 2017 |
Source | Children's Hospital Medical Center, Cincinnati |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 114 |
Est. completion date | July 2010 |
Est. primary completion date | July 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 11 Years to 18 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio |
United States | Cleveland Clinic Foundation, Division of Pediatrics | Cleveland | Ohio |
United States | Kosair Charities Pediatric Center | Louisville | Kentucky |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital Medical Center, Cincinnati | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
United States,
Kashikar-Zuck S, Ting TV, Arnold LM, Bean J, Powers SW, Graham TB, Passo MH, Schikler KN, Hashkes PJ, Spalding S, Lynch-Jordan AM, Banez G, Richards MM, Lovell DJ. Cognitive behavioral therapy for the treatment of juvenile fibromyalgia: a multisite, singl — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in FDI (Functional Disability Inventory) Scores at End of Study | Functional disability score is measured by the Functional Disability Inventory (FDI)which assesses ability to engage in usual physical, social and recreational activities. Scores range from 0=no disability to 60 = extreme disability and and are interpreted as No/Mild disability (0-12); Moderate Disability (13-29) and Severe Disability (30-60) | Baseline and 6 months (end of study) | |
Secondary | Pain Intensity | 9 weeks and 6 months | ||
Secondary | Depressive Symptoms | 9 weeks and 6 months |
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