Status:
COMPLETED
Coping Skills Training for Adolescents With Fibromyalgia
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Collaborating Sponsors:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Conditions:
Fibromyalgia
Eligibility:
All Genders
11-18 years
Phase:
PHASE3
Brief 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 copin...
Detailed Description
Juvenile Primary Fibromyalgia Syndrome (JPFS) is a debilitating chronic pain condition that occurs in adolescence and is characterized by persistent pain, multiple tender points, sleep difficulty, and...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT00086047
Start Date
July 1 2004
End Date
July 1 2010
Last Update
September 20 2017
Active Locations (3)
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1
Kosair Charities Pediatric Center
Louisville, Kentucky, United States, 40202
2
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
3
Cleveland Clinic Foundation, Division of Pediatrics
Cleveland, Ohio, United States, 44195