Nondrug Treatment Programs for Adults With Fibromyalgia
|ClinicalTrials.gov Identifier: NCT00088777|
Recruitment Status : Completed
First Posted : August 5, 2004
Last Update Posted : August 12, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Fibromyalgia||Behavioral: Behavioral coping skills training plus physical therapy Behavioral: Stress management education plus physical therapy||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Behavioral Preparation for Treating Fibromyalgia|
|Study Start Date :||January 2005|
|Primary Completion Date :||April 2010|
|Study Completion Date :||April 2010|
Behavioral: Behavioral coping skills training plus physical therapy
10 hours coping sessions, 6 hours activating physical therapy, 4 hours physical therapy education
Behavioral: Stress management education plus physical therapy
10 hours stress management education, 6 hours activating physical therapy, 4 hours physical therapy education
- Major FM syndrome symptoms immediately following treatment and at 6- and 12-month follow-up evaluations [ Time Frame: post-treatment, 6 month and 12 month follow-ups ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00088777
|United States, Utah|
|University of Utah, Pain Research and Management Center|
|Salt Lake City, Utah, United States, 84108|
|Principal Investigator:||Akiko Okifuji, PhD||University of Utah, Pain Research and Management Center|