Behavioral Treatment of Fibromyalgia

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Ohio University
ClinicalTrials.gov Identifier:
NCT00000398
First received: November 3, 1999
Last updated: November 26, 2013
Last verified: June 2000
  Purpose

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.


Condition Intervention Phase
Fibromyalgia
Behavioral: Coping skills training
Behavioral: Physical exercise training
Behavioral: Coping skills training plus physical exercise training
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Behavioral Treatment of Fibromyalgia

Resource links provided by NLM:


Further study details as provided by Ohio University:

Estimated Enrollment: 180
Study Start Date: July 1996
Estimated Study Completion Date: June 2000
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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000398

Locations
United States, Ohio
Ohio University
Athens, Ohio, United States, 45701
Ohio State University
Columbus, Ohio, United States, 43221
Sponsors and Collaborators
Ohio University
Investigators
Principal Investigator: Christopher France, PhD Ohio University
  More Information

Publications:
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.
Keefe, F.J., France, C. Pain: Biopsychosocial mechanisms and management. Current Directions in Psychological Science 1999; 8:137-141.
Keefe, F.J. "Cognitive Processes and the Pain Experience." In Journal of Musculoskeletal Pain, edited by S.R. Pillemer. 1998; 6:41-45.

ClinicalTrials.gov Identifier: NCT00000398     History of Changes
Other Study ID Numbers: R01 AR44064, R01AR044064, NIAMS-032
Study First Received: November 3, 1999
Last Updated: November 26, 2013
Health Authority: United States: Federal Government

Keywords provided by Ohio University:
Fibromyalgia
Pain
Coping skills training
Physical exercise training
Combined coping skills training and exercise training

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on July 22, 2014