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Behavioral Treatment of Fibromyalgia

This study has been completed.
Information provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

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Descriptive Information Fields
Brief Title  Behavioral Treatment of Fibromyalgia
Official Title  Behavioral Treatment of Fibromyalgia
Brief Summary

Fibromyalgia (FM) is one of the most common rheumatic diseases (conditions or disorders that cause pain or stiffness in the joints, muscles, or bones). It affects 6 million Americans and up to 20 percent of patients seen by doctors who specialize in treating rheumatic diseases. This study will evaluate the effects of two of the most promising nondrug treatments for FM: coping skills training and physical exercise training. We will randomly assign each of 180 patients diagnosed with FM to one of four groups: coping skills training (CST), physical exercise training alone, CST plus physical exercise training, or a waiting list (nontreatment group). We will look at the separate and combined effects of CST and physical exercise training and evaluate how changes in aerobic fitness, self-effectiveness (a person's belief in his or her ability to reach a goal, such as managing one's own disease), and negative pain-related thoughts relate to improvements in pain and disability.

Detailed Description

Fibromyalgia (FM) is characterized by diffuse musculoskeletal pain, discrete tender points at typical soft-tissue sites, fatigue, stiffness, and sleep problems. Of these symptoms, pain is often the primary concern of FM patients and their physicians. Traditional medical approaches to managing FM have limitations (side effects) and have not been effective in managing pain. Given these limitations, treatments that involve nonpharmacologic interventions may represent a valuable addition to patient care. This study will evaluate the effects of two of the most promising nonpharmacologic interventions for FM: coping skills training (CST) for pain management and physical exercise training.

The study is designed to test the hypothesis that an intervention that combines CST and physical exercise training will be more effective than CST or exercise alone. In this study, we will randomly assign each of 180 patients diagnosed with FM to one of four conditions: CST alone, physical exercise training alone, CST plus physical exercise training, or a waiting list control. We will evaluate study participants on four occasions: pre-treatment, post-treatment, 3-month followup, and 6-month followup.

The study will look at the separate and combined effects of CST and physical exercise training and evaluate how changes in aerobic fitness, self-effectiveness, and negative pain-related thoughts relate to improvements in pain and disability. Physicians could use this information in matching FM patients to treatment interventions. In addition, our findings may have implications for treatment selection for a broad range of patients suffering from persistent pain.

Study Phase Phase II
Study Type  Interventional
Study Design  Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Fibromyalgia
Intervention  Behavioral: Coping skills training
Behavioral: Physical exercise training
Behavioral: Coping skills training plus physical exercise training
MEDLINE PMIDs 10030175,   10083960,   9186016
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  180
Start Date  July 1996
Completion Date June 2000
Eligibility Criteria 

Inclusion Criteria:

  • Complaints of pain persisting for 6 months
  • Meet diagnostic criteria for fibromyalgia (American College of Rheumatology criteria)

Exclusion Criteria:

  • A significant adverse medical condition that would expose the individual to increased risk of an adverse experience during the course of the trial (e.g. a recent (<6 months) myocardial infarction)
  • An abnormal cardiac response to exercise
  • Other significant rheumatic disease
  • Receiving or applying for disability or compensation benefits because of fibromyalgia
Gender Both
Ages 21 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00000398
Organization ID R01 AR44064
Secondary IDs †† NIAMS-032
Study Sponsor  National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborators ††
Investigators 
Principal Investigator:     Christopher France, PhD     Ohio University    
Information Provided By National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Verification Date June 2000
First Received Date  November 3, 1999
Last Updated Date December 28, 2006

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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