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Behavioral Treatment of Fibromyalgia

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Coping skills training
Physical exercise training
Coping skills training plus physical exercise training
Sponsored by
Ohio University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring Fibromyalgia, Pain, Coping skills training, Physical exercise training, Combined coping skills training and exercise training

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ohio University
  • Ohio State University

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 3, 1999
Last Updated
November 26, 2013
Sponsor
Ohio University
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
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1. Study Identification

Unique Protocol Identification Number
NCT00000398
Brief Title
Behavioral Treatment of Fibromyalgia
Official Title
Behavioral Treatment of Fibromyalgia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2000
Overall Recruitment Status
Completed
Study Start Date
July 1996 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2000 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Ohio University
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Fibromyalgia, Pain, Coping skills training, Physical exercise training, Combined coping skills training and exercise training

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Coping skills training
Intervention Type
Behavioral
Intervention Name(s)
Physical exercise training
Intervention Type
Behavioral
Intervention Name(s)
Coping skills training plus physical exercise training

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher France, PhD
Organizational Affiliation
Ohio University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ohio University
City
Athens
State/Province
Ohio
ZIP/Postal Code
45701
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43221
Country
United States

12. IPD Sharing Statement

Citations:
Citation
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.
Results Reference
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PubMed Identifier
10030175
Citation
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.
Results Reference
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Citation
Keefe, F.J., France, C. Pain: Biopsychosocial mechanisms and management. Current Directions in Psychological Science 1999; 8:137-141.
Results Reference
background
PubMed Identifier
10083960
Citation
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.
Results Reference
background
PubMed Identifier
9186016
Citation
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.
Results Reference
background
Citation
Keefe, F.J. "Cognitive Processes and the Pain Experience." In Journal of Musculoskeletal Pain, edited by S.R. Pillemer. 1998; 6:41-45.
Results Reference
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Behavioral Treatment of Fibromyalgia

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