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Tailored Treatments of Fibromyalgia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000422
First Posted: November 4, 1999
Last Update Posted: October 30, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dennis Turk, University of Washington
  Purpose
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.

Condition Intervention Phase
Fibromyalgia Behavioral: Cognitive-behavioral psychotherapy and physical exercise Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Subgroups of FMS: Symptoms, Beliefs and Tailored Treatments

Resource links provided by NLM:


Further study details as provided by Dennis Turk, University of Washington:

Estimated Enrollment: 312
Study Start Date: July 1998
Study Completion Date: May 2004
Primary Completion Date: May 2004 (Final data collection date for primary outcome measure)
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female
  • Able to visit Seattle based clinic 9 times
  • Meet ACR criteria for FMS

Exclusion Criteria:

  • Pregnancy
  • Exercise contraindicated by physician due to other medical conditions
  • Significant psychopathology
  • Do not meet FMS criteria
  • Cardiac problems
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000422


Locations
United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Dennis C. Turk, PhD University of Washington
  More Information

Publications:
Robinson JP, Turk DC. Relations between self-reports and physical performance among fibromyalgia syndrome patients. J Pain 4, Number 2 (Suppl 1): 15, 2002.
Turk DC, Robinson JP. Predictors of self-reported activity level and activity limitations in fibromyalgia syndrome. J Pain 4, Number 2 (Suppl 1): 16, 2003.
Burwinkle T, Robinson JP, Turk DC. The role of physical, demographic, and psychological factors in symptom reporting and treatments of fibromyalgia syndrome patients. J Pain 6 (Suppl 1), S79, 2005.
Robinson JP, Turk DC, Burwinkle T, Showlund M. Prevalence of fear in subgroups of Fibromyalgia Syndrome (FMS) Patients. J Pain 5 (Suppl 1): 1109, 2004.

Responsible Party: Dennis Turk, Study Principal Investigator, University of Washington
ClinicalTrials.gov Identifier: NCT00000422     History of Changes
Other Study ID Numbers: 14866-D
R01AR044724 ( U.S. NIH Grant/Contract )
NIAMS-036
First Submitted: November 3, 1999
First Posted: November 4, 1999
Last Update Posted: October 30, 2013
Last Verified: October 2013

Keywords provided by Dennis Turk, University of Washington:
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

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases