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

Further Study Details: 

Expected Total Enrollment:  300

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.

Ages Eligible for Study:  21 Years   -   65 Years,  Genders Eligible for Study:  Both

Criteria

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-injurous 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)

Utah
      University of Utah, Pain Research and Management Center, Salt Lake City,  Utah,  84108,  United States; Recruiting

Study chairs or principal investigators

Akiko Okifuji, PhD,  Principal Investigator,  University of Utah, Pain Research and Management Center   

Study ID Numbers:  NIAMS-119; R01 AR048888-01A2
Record last reviewed:  March 2005
Last Updated:  March 2, 2005
Record first received:  August 4, 2004
ClinicalTrials.gov Identifier:  NCT00088777
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08