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Tailored Treatments of Fibromyalgia

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cognitive-behavioral psychotherapy and physical exercise
Sponsored by
University of Washington
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring 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

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Washington

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 3, 1999
Last Updated
October 29, 2013
Sponsor
University of Washington
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1. Study Identification

Unique Protocol Identification Number
NCT00000422
Brief Title
Tailored Treatments of Fibromyalgia
Official Title
Subgroups of FMS: Symptoms, Beliefs and Tailored Treatments
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
July 1998 (undefined)
Primary Completion Date
May 2004 (Actual)
Study Completion Date
May 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
Single
Allocation
Randomized
Enrollment
312 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Cognitive-behavioral psychotherapy and physical exercise

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dennis C. Turk, PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15943960
Citation
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. doi: 10.1016/j.jpain.2005.01.355.
Results Reference
result
Citation
Robinson JP, Turk DC. Relations between self-reports and physical performance among fibromyalgia syndrome patients. J Pain 4, Number 2 (Suppl 1): 15, 2002.
Results Reference
result
Citation
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.
Results Reference
result
PubMed Identifier
15556826
Citation
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. doi: 10.1016/j.jpain.2004.08.002.
Results Reference
result
Citation
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.
Results Reference
result

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Tailored Treatments of Fibromyalgia

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