Tailored Treatments of Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study will evaluate the effects of matching treatments to people with fibromyalgia
      syndrome (FMS) on the basis of their psychosocial and behavioral characteristics. We will
      look at how patients respond to a rehabilitation program that includes physical therapy and
      information about fibromyalgia. We will combine this program with psychological treatments
      that are either matched or mismatched to the way patients cope with and adapt to symptoms of
      FMS. The second aim of our study is to better understand how different FMS symptoms may vary
      together and how these symptoms change as a result of treatment in a person's natural
      environment. People with FMS and healthy people of the same ages will record their moods,
      thoughts, symptoms, activities, and fatigue levels three times a day for 2 weeks.
      Participants will use palm-top computers to record these "real-time" assessments. This
      approach will permit people to rate how they feel at a particular time rather than looking
      back in time.
    

Detailed description: 
      Fibromyalgia syndrome (FMS) is a prevalent, chronic musculoskeletal pain disorder. Despite
      extensive study, researchers do not understand well the etiology and pathophysiologic
      mechanisms of FMS, and have not shown any treatment to be universally effective. We propose
      that FMS is a complex disorder involving multiple factors, both physical and
      psychosocial-behavioral.

      In our previous research, we demonstrated that FMS patients are heterogeneous in the
      psychosocial-behavioral axis and can be classified into three distinct subgroups on the basis
      of their psychosocial adaptation to symptoms. In this study we will extend our previous
      research and attempt to match treatments to patients' psychosocial-behavioral
      characteristics. Specifically, we will test the efficacy of uniquely tailored treatment for
      each psychosocial subgroup.

      We will treat three groups of FMS patients with one of three treatment protocols involving
      standard physical therapy and varying psychological treatments. A total of 312 FMS patients
      will undergo six half-day interdisciplinary treatment sessions consisting of psychological
      treatments and physical therapy emphasizing aerobic conditioning, pacing, and body mechanics.
      All protocols include a standardized physical therapy and either cognitive-behavioral pain
      management therapy, interpersonal skill training, or supportive counseling.

      In addition to the treatment outcome study, we will prospectively assess various symptoms of
      FMS in the patients' natural habitats to better understand covariations of FMS symptoms.
      Patients will do repeated daily monitoring using a palm-top computer (ecological momentary
      assessment), which will permit us to evaluate process ratings compared to retrospective
      reports.

      Overall, the results of these studies should establish the benefit of matching treatments to
      patient characteristics and enhance our understanding of the roles of
      cognitive-affective-behavioral adaptation by people with FMS.
    

Intervention name(s): Cognitive-behavioral psychotherapy and physical exercise
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Fibromyalgia Syndrome (FMS); Physical therapy; Psychotherapy; Group counseling; Human therapy relations; Interpersonal relations; Chronic pain; Cognition; Emotion; Memory; Musculoskeletal disorder; Psychological stressor; Psychological adaptation; Outcomes research