Pain Management Techniques for Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional
Phase: Phase 1/Phase 2

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.
    

Intervention name(s): Exercise regimen; Relaxation training; Standard Care
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): 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.; 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Internal-External Control; Magnetic Resonance Imaging; fMRI; Exercise; Relaxation