Behavioral Treatment of Fibromyalgia
Completed · Phase 2
Conditions studied: Fibromyalgia
In brief
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.
Key facts
- Study ID
- NCT00000398
- Run by
- Ohio University
- People needed
- 180
- Starts
- 1996-07-01
- Expected to finish
- 2000-06-01
- Last updated by the study team
- 2013-11-27
Who can join
Age: 21 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Complaints of pain persisting for 6 months
- Meet diagnostic criteria for fibromyalgia (American College of Rheumatology criteria)
You may not qualify if…
- 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
Where it is running
- Ohio University — Athens, Ohio, United States
- Ohio State University — Columbus, Ohio, United States
Full record on ClinicalTrials.gov
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