Nondrug Treatment Programs for Adults With Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Behavioral coping skills training plus physical therapy; Stress management education plus physical therapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 10 hours coping sessions, 6 hours activating physical therapy, 4 hours physical therapy education; 10 hours stress management education, 6 hours activating physical therapy, 4 hours physical therapy education
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment