Completed

Subgroups of FMS: Symptoms, Beliefs and Tailored Treatments

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Cognitive-behavioral psychotherapy and physical exercise

Behavioral
Who is being recruted

Behavior+11

+ Behavioral Symptoms

+ Muscular Diseases

From 21 to 65 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2 & 3
Interventional
Study Start: July 1998
See protocol details

Summary

Principal SponsorUniversity of Washington
Last updated: October 30, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 1998

Actual date on which the first participant was enrolled.

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.

NCT00000422
Principal SponsorUniversity of Washington
Last updated: October 30, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

312 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 21 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

BehaviorBehavioral SymptomsMuscular DiseasesNervous System DiseasesNeurologic ManifestationsNeuromuscular DiseasesPainRheumatic DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsFibromyalgiaMusculoskeletal DiseasesStress, PsychologicalChronic Pain

Criteria

3 inclusion criteria required to participate
Able to visit Seattle based clinic 9 times

Female

Meet ACR criteria for FMS

5 exclusion criteria prevent from participating
Cardiac problems

Do not meet FMS criteria

Exercise contraindicated by physician due to other medical conditions

Pregnancy

Show More Criteria

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

University of Washington

Seattle, United StatesOpen University of Washington in Google Maps
CompletedOne Study Center