Note: This study is still recruiting participants with fibromyalgia and no longer recruiting
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.
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.
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
- 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
- Uncontrolled endocrine or allergic disorders (e.g., thyroid dysfunction, Type I
- 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'