Clinical trial NCT00086060: Pain Management Techniques for Fibromyalgia
Official title: Locus of Pain Control: Neural Substrates and Modifiability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Fibromyalgia
Keywords: Internal-External Control
Magnetic Resonance Imaging
fMRI
Exercise
Relaxation
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2004-06-23
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Change in clinical pain
timeFrame: Measured at Week 8
measure: Change in activation pattern in fMRI
timeFrame: Measured at Week 8
measure: Change in locus of control
timeFrame: Measured at Week 8
Secondary outcomes:
measure: Improvement in symptoms
timeFrame: Measured at Week 8
measure: Improvement in function
timeFrame: Measured at Week 8
measure: Improvement in mood
timeFrame: Measured at Week 8
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Chronic Pain and Fatigue Research Center, University of Michigan
state: Michigan
Study officials:
affiliation: Chronic Pain and Fatigue Research Center, University of Michigan
name: David A. Williams, PhD
role: PRINCIPAL_INVESTIGATOR
References: