Coping Skills Training for Adolescents With Fibromyalgia
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| ClinicalTrials.gov Identifier: NCT00086047 |
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Recruitment Status :
Completed
First Posted : June 23, 2004
Results First Posted : November 6, 2013
Last Update Posted : September 20, 2017
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Fibromyalgia | Behavioral: Coping Skills Training Behavioral: Education | Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 114 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | Randomized Clinical Trial in Juvenile Fibromyalgia |
| Study Start Date : | July 2004 |
| Actual Primary Completion Date : | July 2010 |
| Actual Study Completion Date : | July 2010 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Coping Skills
Patients will receive 8 weeks of behavioral training in pain coping strategies
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Behavioral: Coping Skills Training
8 weekly sessions of behavioral treatment
Other Name: cognitive-behavioral therapy |
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Active Comparator: Education
Patient will receive 8 weekly sessions of education about fibromyalgia syndrome.
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Behavioral: Education
8 weekly sessions of fibromyalgia education |
- Change in FDI (Functional Disability Inventory) Scores at End of Study [ Time Frame: Baseline and 6 months (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)
- Pain Intensity [ Time Frame: 9 weeks and 6 months ]
- Depressive Symptoms [ Time Frame: 9 weeks and 6 months ]
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| Ages Eligible for Study: | 11 Years to 18 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00086047
| United States, Kentucky | |
| Kosair Charities Pediatric Center | |
| Louisville, Kentucky, United States, 40202 | |
| United States, Ohio | |
| Cincinnati Children's Hospital Medical Center | |
| Cincinnati, Ohio, United States, 45229 | |
| Cleveland Clinic Foundation, Division of Pediatrics | |
| Cleveland, Ohio, United States, 44195 | |
| Principal Investigator: | Susmita Kashikar-Zuck, PhD | Children's Hospital Medical Center, Cincinnati |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Children's Hospital Medical Center, Cincinnati |
| ClinicalTrials.gov Identifier: | NCT00086047 |
| Other Study ID Numbers: |
R01AR050028 ( U.S. NIH Grant/Contract ) R01AR050028 ( U.S. NIH Grant/Contract ) |
| First Posted: | June 23, 2004 Key Record Dates |
| Results First Posted: | November 6, 2013 |
| Last Update Posted: | September 20, 2017 |
| Last Verified: | August 2017 |
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Juvenile Fibromyalgia Syndrome JPFS Fibromyalgia |
Chronic Pain Pediatric Pain Juvenile Fibromyalgia |
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Fibromyalgia Myofascial Pain Syndromes Muscular Diseases Musculoskeletal Diseases |
Rheumatic Diseases Neuromuscular Diseases Nervous System Diseases |