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Tailored Treatments of Fibromyalgia
This study has been completed.
Sponsored by: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
ClinicalTrials.gov Identifier: NCT00000422
  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 II
Phase III

MedlinePlus related topics: Fibromyalgia
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Active Control, Single Group Assignment, Efficacy Study
Official Title: Subgroups of FMS: Symptoms, Beliefs and Tailored Treatments

Further study details as provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):

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

Ages Eligible for Study:   21 Years to 65 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00000422

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

Fibromyalgia Research Program Home Page. Click here for more information about this study.  This link exits the ClinicalTrials.gov site

Publications of Results:
Burwinkle T, Robinson JP, Turk DC. Fear of movement: factor structure of the tampa scale of kinesiophobia in patients with fibromyalgia syndrome. J Pain. 2005 Jun;6(6):384-91.
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.
Turk DC, Robinson JP, Burwinkle T. Prevalence of fear of pain and activity in patients with fibromyalgia syndrome. J Pain. 2004 Nov;5(9):483-90.
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: Department of Anesthesiology - University of Washington ( Dennis C. Turk, Ph.D. )
Study ID Numbers: R01 AR44724, NIAMS-036
Study First Received: November 3, 1999
Last Updated: March 28, 2008
ClinicalTrials.gov Identifier: NCT00000422  
Health Authority: United States: Federal Government

Keywords provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):
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

Study placed in the following topic categories:
Muscular Diseases
Neuromuscular Diseases
Musculoskeletal Diseases
Myofascial Pain Syndromes
Fibromyalgia
Pain
Rheumatic Diseases

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on January 15, 2009