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| Sponsored by: |
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
|---|---|
| Information provided by: | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
| ClinicalTrials.gov Identifier: | NCT00086047 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Fibromyalgia |
Behavioral: Coping Skills Training Behavioral: Education |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Randomized Clinical Trial in Juvenile Fibromyalgia |
| Estimated Enrollment: | 116 |
| Study Start Date: | July 2004 |
| Estimated Study Completion Date: | June 2009 |
| Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Coping Skills: Experimental
Patients will receive 8 weeks of behavioral training in pain coping strategies
|
Behavioral: Coping Skills Training
8 weekly sessions of behavioral treatment
|
|
Education: Active Comparator
Patient will receive 8 weekly sessions of education about fibromyalgia syndrome.
|
Behavioral: Education
8 weekly sessions of fibromyalgia education
|
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 fatigue. The cause of JPFS is unknown and there is no known cure. Children and adolescents with JPFS have difficulty with daily functioning, miss a great deal of school, and experience increased emotional distress compared to their peers. Fibromyalgia syndrome appears to be resistant to treatment in adulthood, so early behavioral treatment for JPFS with long-term beneficial effects would be useful. This study will evaluate the efficacy of coping skills training (CST) when combined with usual medical care in reducing functional disability, pain intensity, and depressive symptoms in adolescents with JPFS. This study will also determine whether improvements can be sustained long-term.
This study will last 34 weeks. Participants will be recruited from three pediatric rheumatology clinics. Patients will be randomly assigned to one of two groups: CST plus usual medical care or education plus usual medical care. There will be 6 medical visits, spaced 4 to 5 weeks apart. In addition, patients will attend 8 individual sessions of CST or education over the first 8 weeks of the study. CST sessions will include training in cognitive-behavioral techniques of pain management for the adolescent and behavioral management techniques for their parents. Education sessions will include education on fibromyalgia and discussion about lifestyle issues, but no training in pain management procedures.
Patients will be evaluated at Week 9 and will be followed for an additional 6-month maintenance phase. During this maintenance phase, adolescents will continue to receive their usual medical care and will attend 2 additional sessions of CST or education. There will be one final evaluation at the end of the maintenance phase.
Eligibility| Ages Eligible for Study: | 11 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Susmita Kashikar-Zuck, PhD | 513-636-6337 | Susmita.Kashikar-Zuck@cchmc.org |
| United States, Kentucky | |
| Kosair Charities Pediatric Center | Recruiting |
| Louisville, Kentucky, United States, 40202 | |
| Contact: Kenneth Schikler, MD 502-852-3721 | |
| Sub-Investigator: Kenneth Schikler, MD | |
| United States, Ohio | |
| Cincinnati Children's Hospital Medical Center | Recruiting |
| Cincinnati, Ohio, United States, 45229 | |
| Contact: Susmita Kashikar-Zuck, PhD 513-636-6337 Susmita.Kashikar-Zuck@cchmc.org | |
| Contact: Emily Verkamp, BA 513-636-1846 Emily.Verkamp@cchmc.org | |
| Principal Investigator: Susmita Kashikar-Zuck, PhD | |
| Cleveland Clinic Foundation, Division of Pediatrics | Recruiting |
| Cleveland, Ohio, United States, 44195 | |
| Contact: Sonya Crook, RN 216-444-3290 crooks@ccf.org | |
| Sub-Investigator: Phil Hashkes, MD | |
| Principal Investigator: | Susmita Kashikar-Zuck, PhD | Children's Hospital Medical Center, Cincinnati |
More Information
| Responsible Party: | Cincinnati Children's Hospital Medical Center ( Susmita Kashikar-Zuck, PhD./Associate Professor ) |
| Study ID Numbers: | NIAMS-120, R01 AR050028-01A1 |
| Study First Received: | June 22, 2004 |
| Last Updated: | September 22, 2008 |
| ClinicalTrials.gov Identifier: | NCT00086047 |
| Health Authority: | United States: Federal Government |
|
Juvenile Fibromyalgia Syndrome JPFS Fibromyalgia |
Chronic Pain Pediatric Pain Juvenile Fibromyalgia |
|
Muscular Diseases Neuromuscular Diseases Musculoskeletal Diseases Myofascial Pain Syndromes |
Fibromyalgia Pain Rheumatic Diseases |
|
Nervous System Diseases |
