Behavioral Treatment of Fibromyalgia

NCT ID: NCT00000398

Last Updated: 2013-11-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1996-07-31
• Study Completion Date: 2000-06-30

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.

Conditions

Fibromyalgia

Keywords

Fibromyalgia; Pain; Coping skills training; Physical exercise training; Combined coping skills training and exercise training

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Coping skills training

Intervention Type: BEHAVIORAL

Physical exercise training

Intervention Type: BEHAVIORAL

Coping skills training plus physical exercise training

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

Sponsor Role: collaborator

Ohio University

OTHER

Sponsor Role: lead

Principal Investigators

Christopher France, PhD

Role: PRINCIPAL_INVESTIGATOR

Ohio University

Locations

Ohio University

Athens, Ohio, United States

Ohio State University

Columbus, Ohio, United States

Countries

United States

References

Lester, N., and F.J. Keefe. "Coping With Chronic Pain." In Cambridge Handbook of Psychology, Health and Medicine, edited by A. Baum, C. McManus, S. Newman, J. Weinman, and R. West. Cambridge, England: Cambridge University Press, 1997.

Reference Type: BACKGROUND

Sandstrom MJ, Keefe FJ. Self-management of fibromyalgia: the role of formal coping skills training and physical exercise training programs. Arthritis Care Res. 1998 Dec;11(6):432-47. doi: 10.1002/art.1790110603.

Reference Type: BACKGROUND

PMID: 10030175 (View on PubMed)

Keefe, F.J., France, C. Pain: Biopsychosocial mechanisms and management. Current Directions in Psychological Science 1999; 8:137-141.

Reference Type: BACKGROUND

Keefe FJ, Bonk V. Psychosocial assessment of pain in patients having rheumatic diseases. Rheum Dis Clin North Am. 1999 Feb;25(1):81-103. doi: 10.1016/s0889-857x(05)70056-9.

Reference Type: BACKGROUND

PMID: 10083960 (View on PubMed)

Keefe FJ, Jacobs M, Underwood-Gordon L. Biobehavioral pain research: a multi-institute assessment of cross-cutting issues and research needs. Clin J Pain. 1997 Jun;13(2):91-103. doi: 10.1097/00002508-199706000-00003.

Reference Type: BACKGROUND

PMID: 9186016 (View on PubMed)

Keefe, F.J. "Cognitive Processes and the Pain Experience." In Journal of Musculoskeletal Pain, edited by S.R. Pillemer. 1998; 6:41-45.

Reference Type: BACKGROUND

Other Identifiers

R01AR044064

Identifier Type: NIH

Identifier Source: secondary_id

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NIAMS-032

Identifier Type: -

Identifier Source: secondary_id

R01AR044064

Identifier Type: NIH

Identifier Source: org_study_id

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