View Clinical Trial (Medical Research Study)
Randomized Clinical Trial in Juvenile Fibromyalgia
| City: |
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Cincinnati |
| State: |
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Ohio |
| Zip Code: |
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45229 |
| Conditions: |
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Fibromyalgia |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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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
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| NCT ID: |
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NCT00086047 |
| Primary Contact: |
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Principal Investigator
Susmita Kashikar-Zuck, PhD
Children's Hospital Medical Center, Cincinnati
Susmita Kashikar-Zuck, PhD
Phone: 513-636-6337
Email: Susmita.Kashikar-Zuck@cchmc.org
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| Backup Contact: |
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N/A |
| Location Contact: |
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Cincinnati, Ohio 45229
United States
Susmita Kashikar-Zuck, PhD
Phone: 513-636-6337
Email: Susmita.Kashikar-Zuck@cchmc.org
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 23, 2013 |
| Modifications to this listing: |
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