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Nondrug Treatment Programs for Adults With Fibromyalgia

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Behavioral coping skills training plus physical therapy
Stress management education plus physical therapy
Sponsored by
University of Utah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Diagnosis of fibromyalgia Have not been actively exercising (e.g., aerobic activity such as cycling, jogging, climbing, rowing, and muscle strengthening activity) for more than 30 minutes per week Exclusion Criteria: Other progressive disease Plan to have surgery during the next year Pregnancy or planning to become pregnant during the next year Resting diastolic blood pressure greater than 115 mm Hg or resting systolic blood pressure greater than 200 mg Hg Cardiovascular diseases Serious psychopathology (e.g., diagnoses of psychosis, organic mental disorder, or dissociative disorder; active suicidal intent; inpatient admission to psychiatric ward or incidence of self-injurious behaviors in the past year) Non-IV substance abuse within the last 2 years, or history of recreational IV drug use Other rheumatologic disorder (e.g., rheumatoid arthritis) Neuropathic pain Pain associated with terminal illness, acute pain, or pain associated with specific organ damage (e.g., stomach ulcer)

Sites / Locations

  • University of Utah, Pain Research and Management Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

MET

CSE

Arm Description

Outcomes

Primary Outcome Measures

Major FM syndrome symptoms immediately following treatment and at 6- and 12-month follow-up evaluations

Secondary Outcome Measures

Full Information

First Posted
August 4, 2004
Last Updated
August 10, 2011
Sponsor
University of Utah
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
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1. Study Identification

Unique Protocol Identification Number
NCT00088777
Brief Title
Nondrug Treatment Programs for Adults With Fibromyalgia
Official Title
Behavioral Preparation for Treating Fibromyalgia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

Brief Summary
Fibromyalgia (FM) syndrome is a common chronic pain disorder that may benefit from nondrug treatment. This study will compare the effectiveness of behavioral preparation, stress management education, and fibromyalgia and coping education in relieving the symptoms of FM. Each of these nondrug treatments will be combined with physical therapy and physical education. Specific aims: 1) Evaluate the efficacy of behavioral preparation programs on attrition, compliance, and treatment outcomes of self-management rehabilitation for FM syndrome. 2) Determine factors that mediate clinical efficacy. 3) Evaluate individual differences in treatment responses to delineate who will benefit most from each type of the behavioral preparation programs.
Detailed Description
FM is a chronic pain condition causing discomfort and disability; there is no known cure. Research suggests that combination treatment of physical therapy, fibromyalgia education, and stress management education is helpful for many patients with this condition. However, how much benefit patients get from such therapies varies greatly. This study will evaluate the effectiveness of behavioral preparation, stress management education, and fibromyalgia and coping education each in combination with physical therapy and physical education, in relieving the symptoms of FM. The study will last approximately 15 months. Participants will undergo a comprehensive assessment including medical, physical, and psychological evaluations. Blood will be collected to measure participants' serotonin levels; participants will also be asked to complete several questionnaires to assess their FM symptoms and joint function. For a 7-day period prior to starting behavioral interventions, participants will be asked to carry a personal-size digit assistant (PDA) that will ask them questions about their quality of life three times a day . During this time, they will also continuously wear a wristwatch-like device to measure functional movement and quality of sleep. For 10 weeks, participants will undergo therapy sessions of one of the behavioral interventions (behavioral preparation, stress management education, or fibromyalgia and coping education) along with physical therapy and physical education. During Weeks 1 through 4, participants will receive 2 hours of their assigned intervention. During Weeks 5 and 6, they will receive 1 hour of their assigned intervention and 1 hour of physical therapy. During Weeks 7 through 9, they will receive 1 hour of physical therapy and 1 hour of physical education. During Week 10, they will receive 1 hour of their assigned intervention and 1 hour of physical therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MET
Arm Type
Experimental
Arm Title
CSE
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Behavioral coping skills training plus physical therapy
Intervention Description
10 hours coping sessions, 6 hours activating physical therapy, 4 hours physical therapy education
Intervention Type
Behavioral
Intervention Name(s)
Stress management education plus physical therapy
Intervention Description
10 hours stress management education, 6 hours activating physical therapy, 4 hours physical therapy education
Primary Outcome Measure Information:
Title
Major FM syndrome symptoms immediately following treatment and at 6- and 12-month follow-up evaluations
Time Frame
post-treatment, 6 month and 12 month follow-ups

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of fibromyalgia Have not been actively exercising (e.g., aerobic activity such as cycling, jogging, climbing, rowing, and muscle strengthening activity) for more than 30 minutes per week Exclusion Criteria: Other progressive disease Plan to have surgery during the next year Pregnancy or planning to become pregnant during the next year Resting diastolic blood pressure greater than 115 mm Hg or resting systolic blood pressure greater than 200 mg Hg Cardiovascular diseases Serious psychopathology (e.g., diagnoses of psychosis, organic mental disorder, or dissociative disorder; active suicidal intent; inpatient admission to psychiatric ward or incidence of self-injurious behaviors in the past year) Non-IV substance abuse within the last 2 years, or history of recreational IV drug use Other rheumatologic disorder (e.g., rheumatoid arthritis) Neuropathic pain Pain associated with terminal illness, acute pain, or pain associated with specific organ damage (e.g., stomach ulcer)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Akiko Okifuji, PhD
Organizational Affiliation
University of Utah, Pain Research and Management Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Utah, Pain Research and Management Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States

12. IPD Sharing Statement

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Nondrug Treatment Programs for Adults With Fibromyalgia

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