NCT00000398

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 1996

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1996

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 1999

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2000

Completed
Last Updated

November 27, 2013

Status Verified

June 1, 2000

First QC Date

November 3, 1999

Last Update Submit

November 26, 2013

Conditions

Fibromyalgia

Keywords

FibromyalgiaPainCoping skills trainingPhysical exercise trainingCombined coping skills training and exercise training

Interventions

Coping skills trainingBEHAVIORAL
Physical exercise trainingBEHAVIORAL
Coping skills training plus physical exercise trainingBEHAVIORAL

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ohio University

Athens, Ohio, 45701, United States

Location

Ohio State University

Columbus, Ohio, 43221, United States

Location

Related Publications (6)

  • 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.

    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.

    PMID: 10030175BACKGROUND

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

    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.

    PMID: 10083960BACKGROUND

  • 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.

    PMID: 9186016BACKGROUND

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

    BACKGROUND

MeSH Terms

Conditions

FibromyalgiaPain

Interventions

Exercise

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Christopher France, PhD

    Ohio University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 3, 1999

First Posted

November 4, 1999

Study Start

July 1, 1996

Study Completion

June 1, 2000

Last Updated

November 27, 2013

Record last verified: 2000-06

Locations

US(2)