Fibromyalgia Clinical Trial
Official title:
Behavioral Preparation for Treating Fibromyalgia
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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