Fibromyalgia Clinical Trial
Official title:
Behavioral Preparation for Treating Fibromyalgia
Verified date | August 2011 |
Source | University of Utah |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
Fibromyalgia (FM) syndrome is a common chronic pain disorder that may benefit from nondrug
treatment. This study will compare the effectiveness of behavioral preparation, stress
management education, and fibromyalgia and coping education in relieving the symptoms of FM.
Each of these nondrug treatments will be combined with physical therapy and physical
education.
Specific aims: 1) Evaluate the efficacy of behavioral preparation programs on attrition,
compliance, and treatment outcomes of self-management rehabilitation for FM syndrome. 2)
Determine factors that mediate clinical efficacy. 3) Evaluate individual differences in
treatment responses to delineate who will benefit most from each type of the behavioral
preparation programs.
Status | Completed |
Enrollment | 300 |
Est. completion date | April 2010 |
Est. primary completion date | April 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 21 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Diagnosis of fibromyalgia - Have not been actively exercising (e.g., aerobic activity such as cycling, jogging, climbing, rowing, and muscle strengthening activity) for more than 30 minutes per week Exclusion Criteria: - Other progressive disease - Plan to have surgery during the next year - Pregnancy or planning to become pregnant during the next year - Resting diastolic blood pressure greater than 115 mm Hg or resting systolic blood pressure greater than 200 mg Hg - Cardiovascular diseases - Serious psychopathology (e.g., diagnoses of psychosis, organic mental disorder, or dissociative disorder; active suicidal intent; inpatient admission to psychiatric ward or incidence of self-injurious behaviors in the past year) - Non-IV substance abuse within the last 2 years, or history of recreational IV drug use - Other rheumatologic disorder (e.g., rheumatoid arthritis) - Neuropathic pain - Pain associated with terminal illness, acute pain, or pain associated with specific organ damage (e.g., stomach ulcer) |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Utah, Pain Research and Management Center | Salt Lake City | Utah |
Lead Sponsor | Collaborator |
---|---|
University of Utah | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Major FM syndrome symptoms immediately following treatment and at 6- and 12-month follow-up evaluations | post-treatment, 6 month and 12 month follow-ups | No |
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