Pain Management Techniques for Fibromyalgia
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|ClinicalTrials.gov Identifier: NCT00086060|
Recruitment Status : Completed
First Posted : June 23, 2004
Last Update Posted : October 10, 2011
|Condition or disease||Intervention/treatment||Phase|
|Fibromyalgia||Behavioral: Exercise regimen Behavioral: Relaxation training Behavioral: Standard Care||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||97 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Locus of Pain Control: Neural Substrates and Modifiability|
|Study Start Date :||May 2004|
|Actual Primary Completion Date :||February 2008|
|Actual Study Completion Date :||February 2008|
Experimental: 1 - Relaxation Training
Participants will receive relaxation training and standard care for FM
Behavioral: Relaxation training
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.
Experimental: 2 Exercise Regimen
Participants will receive an exercise regimen and standard care for FM
Behavioral: Exercise regimen
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.
Active Comparator: 3 Standard Care
Participants will receive standard of care for FM
Behavioral: Standard Care
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.
No Intervention: 4 Health Controls
Health participants will act as a control
- Change in clinical pain [ Time Frame: Measured at Week 8 ]
- Change in activation pattern in fMRI [ Time Frame: Measured at Week 8 ]
- Change in locus of control [ Time Frame: Measured at Week 8 ]
- Improvement in symptoms [ Time Frame: Measured at Week 8 ]
- Improvement in function [ Time Frame: Measured at Week 8 ]
- Improvement in mood [ Time Frame: Measured at Week 8 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00086060
|United States, Michigan|
|Chronic Pain and Fatigue Research Center, University of Michigan|
|Ann Arbor, Michigan, United States, 48106|
|Principal Investigator:||David A. Williams, PhD||Chronic Pain and Fatigue Research Center, University of Michigan|