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Nondrug Treatment Programs for Adults with Fibromyalgia
This study is not yet open for patient recruitment.
Sponsored by: | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
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Information provided by: | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
Purpose
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.
Condition | Treatment or Intervention | Phase |
---|---|---|
Fibromyalgia |
Behavior: Behavioral coping skills training Behavior: Stress management education Behavior: Fibromyalgia education Procedure: Physical therapy Behavior: Physical education |
Phase II |
MedlinePlus related topics: Fibromyalgia
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title: Behavioral Preparation for Treating Fibromyalgia
Expected Total Enrollment: 300
Study start: January 2005
FM is a chronic pain condition causing discomfort and disability; there is no known cure. Research suggests that combination treatment of physical therapy, fibromyalgia education, and stress management education is helpful for many patients with this condition. However, how much benefit patients get from such therapies varies greatly. This study will evaluate the effectiveness of behavioral preparation, stress management education, and fibromyalgia and coping education each in combination with physical therapy and physical education, in relieving the symptoms of FM.
The study will last approximately 15 months. Participants will undergo a comprehensive assessment including medical, physical, and psychological evaluations. Blood will be collected to measure participants' serotonin levels; participants will also be asked to complete several questionnaires to assess their FM symptoms and joint function. For a 7-day period prior to starting behavioral interventions, participants will be asked to carry a personal-size digit assistant (PDA) that will ask them questions about their quality of life three times a day . During this time, they will also continuously wear a wristwatch-like device to measure functional movement and quality of sleep.
For 10 weeks, participants will undergo therapy sessions of one of the behavioral interventions (behavioral preparation, stress management education, or fibromyalgia and coping education) along with physical therapy and physical education. During Weeks 1 through 4, participants will receive 2 hours of their assigned intervention. During Weeks 5 and 6, they will receive 1 hour of their assigned intervention and 1 hour of physical therapy. During Weeks 7 through 9, they will receive 1 hour of physical therapy and 1 hour of physical education. During Week 10, they will receive 1 hour of their assigned intervention and 1 hour of physical therapy.
There will be 3 study visits after the end of treatment. One week and 6 months post-treatment, participants will be re-evaluated with exams similar to those conducted at baseline. Participants will also complete questionnaires and undergo the 7-day PDA and wristwatch monitoring procedures. Prior to the 6 month evaluation, participants will be contacted by phone monthly and asked about the severity of their FM symptoms. Twelve months post-treatment, participants will again complete questionnaires and undergo the 7-day PDA and wristwatch monitoring procedures.
Eligibility
Ages Eligible for Study: 21 Years - 65 Years, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
Exclusion Criteria:
Location Information
More Information
U.S. National Library of Medicine, Contact NLM Customer Service | ||||||||||||||
National Institutes of Health, Department of Health & Human Services | ||||||||||||||
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