Fibromyalgia Clinical Trial
Official title:
Subgroups of FMS: Symptoms, Beliefs and Tailored Treatments
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.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment
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