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Pain Management Techniques for Fibromyalgia

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Exercise regimen
Relaxation training
Standard Care
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring Internal-External Control, Magnetic Resonance Imaging, fMRI, Exercise, Relaxation

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Note: Given that this study requires participation in a number of appointments and reimbursement will not be made for travel expenses, individuals residing more than 100 miles from Ann Arbor are not encouraged to participate in this project. Inclusion Criteria for Arms 1, 2, and 3: Diagnosis of fibromyalgia based on the criteria outlined by the American College of Rheumatology Standard medical care for fibromyalgia with the referring physician for at least the past 3 months Exclusion Criteria for All Participants: Severe physical impairment that would prevent the participant from receiving either of the nondrug interventions (e.g., complete blindness, deafness, paraplegia) or coexisting physical impairments that could be harmed by light exercise (e.g., sprained ankle, neck injury) Morbid obesity Autoimmune disease Cardiopulmonary disorders (e.g., angina, congestive heart failure, COPD, chronic asthma) Uncontrolled endocrine or allergic disorders (e.g., thyroid dysfunction, Type I diabetes) Cancer within the past 2 years Current psychiatric disorder involving a history of psychosis (e.g., schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder), current suicide risk or suicide attempt within 2 years of study entry, or substance abuse within 2 years of study entry. Participants with mood disorders will not be excluded. Any pending or active disability associated with fibromyalgia (e.g., SSI, Workers' Compensation)

Sites / Locations

  • Chronic Pain and Fatigue Research Center, University of Michigan

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

No Intervention

Arm Label

1 - Relaxation Training

2 Exercise Regimen

3 Standard Care

4 Health Controls

Arm Description

Participants will receive relaxation training and standard care for FM

Participants will receive an exercise regimen and standard care for FM

Participants will receive standard of care for FM

Health participants will act as a control

Outcomes

Primary Outcome Measures

Change in clinical pain
Change in activation pattern in fMRI
Change in locus of control

Secondary Outcome Measures

Improvement in symptoms
Improvement in function
Improvement in mood

Full Information

First Posted
June 22, 2004
Last Updated
October 6, 2011
Sponsor
University of Michigan
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
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1. Study Identification

Unique Protocol Identification Number
NCT00086060
Brief Title
Pain Management Techniques for Fibromyalgia
Official Title
Locus of Pain Control: Neural Substrates and Modifiability
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Pain management techniques may influence how the brain processes pain and may help patients with fibromyalgia (FM), a chronic pain condition. This study will train patients with FM to use pain management techniques. Investigators will use brain scanning (functional magnetic resonance imaging, or fMRI) technology to identify changes in how a patient's brain processes pain over time. This study is primarily interested in examining cortical response to different behavioral interventions.
Detailed Description
FM is a chronic pain condition that has no cure, and drugs are only partially successful in managing its symptoms. Many people with FM utilize nondrug management methods, such as exercise, for symptom relief. Nondrug methods can be quite effective, but some patients find it difficult to use these methods consistently. This study will determine which nondrug methods relieve FM symptoms by examining patients' brains after exercise or relaxation techniques. Preliminary data indicate that beliefs about one's personal ability to control pain result in use of differential neural mechanisms to process pain. This study will use fMRI, a tool for visualizing pain-processing patterns, to gain insights into how exercise and relaxation techniques modify pain processing in patients with FM. There are four arms in this study. All participants with FM will be randomly assigned to one of three study arms. Participants in Arm 1 will receive relaxation training to supplement standard care for FM. Arm 2 participants will be prescribed an exercise regimen to supplement standard care. Participants in Arm 3 will receive standard care only. Arm 4 is a healthy control group, which will be followed during the 8-week intervention period. At baseline, all participants will undergo blood collection and physical examination and will complete questionnaires about demographics, treatment history, symptoms, functional status, affective status, and beliefs about pain. They will also undergo a baseline fMRI imaging study, combined with evoked pressure pain testing, to evaluate differences in neural mechanisms involved in pain processing. Patients in Arms 1 and 2 will then attend one face-to-face training session with a therapist, followed by phone contact over the next 8 weeks. Participants will be asked to record pain and adherence to treatment on an electronic diary. After 8 weeks, all study participants will undergo a second fMRI scan, blood collection, and physical examination, and will complete questionnaires similar to those completed at baseline.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Internal-External Control, Magnetic Resonance Imaging, fMRI, Exercise, Relaxation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
97 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1 - Relaxation Training
Arm Type
Experimental
Arm Description
Participants will receive relaxation training and standard care for FM
Arm Title
2 Exercise Regimen
Arm Type
Experimental
Arm Description
Participants will receive an exercise regimen and standard care for FM
Arm Title
3 Standard Care
Arm Type
Active Comparator
Arm Description
Participants will receive standard of care for FM
Arm Title
4 Health Controls
Arm Type
No Intervention
Arm Description
Health participants will act as a control
Intervention Type
Behavioral
Intervention Name(s)
Exercise regimen
Intervention Description
Aerobic Exercise is a self-management technique that increases personal control over pain by enhancing physical fitness. Patients will be encouraged to choose activities best suited to their tastes and current lifestyle, incorporating lifestyle physical activities (climbing stairs, household chores, etc) and more traditional exercise activities (walking, cycling, etc.). Subjects will use ratings of perceived exertion (RPE) to guide their effort. The intervention will consist of two-hours of face-to-face contact followed by weekly telephone contact for 8 weeks. Face-to-face contract will include receiving a standardized instruction manual for exercise, a demonstration on how to perform relaxation, and tailoring homework assignments to be monitored on the weekly phone call.
Intervention Type
Behavioral
Intervention Name(s)
Relaxation training
Intervention Description
Relaxation is a self-management technique that increases personal control over pain by relaxing tense muscles, allowing the body to rest, and improving mental clarity through concentration and attention and has a great deal of empirical research supporting its effectiveness as a means of pain management. A variety of relaxation skills will be taught with some being based on muscle relaxation, and others focused more on cognitive relaxation and imagery. The intervention will consist of two-hours of face-to-face contact followed by weekly telephone contact for 8 weeks. Face-to-face contract will include receiving a standardized instruction manual for relaxation, a demonstration on how to perform relaxation, and tailoring homework assignments to be monitored on the weekly phone call.
Intervention Type
Behavioral
Intervention Name(s)
Standard Care
Intervention Description
Participants in the standard care control group will not receive any additional intervention beyond that which they are receiving from their routine health care professional.
Primary Outcome Measure Information:
Title
Change in clinical pain
Time Frame
Measured at Week 8
Title
Change in activation pattern in fMRI
Time Frame
Measured at Week 8
Title
Change in locus of control
Time Frame
Measured at Week 8
Secondary Outcome Measure Information:
Title
Improvement in symptoms
Time Frame
Measured at Week 8
Title
Improvement in function
Time Frame
Measured at Week 8
Title
Improvement in mood
Time Frame
Measured at Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Note: Given that this study requires participation in a number of appointments and reimbursement will not be made for travel expenses, individuals residing more than 100 miles from Ann Arbor are not encouraged to participate in this project. Inclusion Criteria for Arms 1, 2, and 3: Diagnosis of fibromyalgia based on the criteria outlined by the American College of Rheumatology Standard medical care for fibromyalgia with the referring physician for at least the past 3 months Exclusion Criteria for All Participants: Severe physical impairment that would prevent the participant from receiving either of the nondrug interventions (e.g., complete blindness, deafness, paraplegia) or coexisting physical impairments that could be harmed by light exercise (e.g., sprained ankle, neck injury) Morbid obesity Autoimmune disease Cardiopulmonary disorders (e.g., angina, congestive heart failure, COPD, chronic asthma) Uncontrolled endocrine or allergic disorders (e.g., thyroid dysfunction, Type I diabetes) Cancer within the past 2 years Current psychiatric disorder involving a history of psychosis (e.g., schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder), current suicide risk or suicide attempt within 2 years of study entry, or substance abuse within 2 years of study entry. Participants with mood disorders will not be excluded. Any pending or active disability associated with fibromyalgia (e.g., SSI, Workers' Compensation)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David A. Williams, PhD
Organizational Affiliation
Chronic Pain and Fatigue Research Center, University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chronic Pain and Fatigue Research Center, University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States

12. IPD Sharing Statement

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Pain Management Techniques for Fibromyalgia

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