Status:
COMPLETED
Developing Biomarkers for Fibromyalgia
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
The Dana Foundation
United States Department of Defense
Conditions:
Fibromyalgia
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The hypothesis of this study is that biological markers are present in the body that are good indicators of chronic pain. Eligible participants will be assessed at baseline and after receiving a serie...
Eligibility Criteria
Inclusion
- Inclusion Criteria for Fibromyalgia Volunteers:
- Has met American College of Rheumatology (1990) criteria for the diagnosis of fibromyalgia for at least 1 year
- Chronic pain more than 50% of days
- Willing to limit introduction of any new medications or treatments for fibromyalgia during the study
- Able to attend study visits up to three times weekly
- Right-handed
- Be capable of giving written informed consent
- Inclusion Criteria for Healthy Volunteers:
- Willing to refrain from alcohol intake for 48 hours prior to brain scans
- Be right handed
- Be capable of giving written informed consent
- PET
- Willing to refrain from alcohol intake 48 hours prior to brain scans
- Capable of giving written consent
Exclusion
- Exclusion Criteria for Fibromyalgia Volunteers:
- Knowledge that could prevent "blinding" of the participant to the study interventions (including previous acupuncture treatment)
- Presence of a known coagulation abnormality, thrombocytopenia, or bleeding diathesis that may preclude the safe use of acupuncture
- Autoimmune or inflammatory disease (in addition to fibromyalgia) that causes pain (e.g., rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease)
- Daily use of narcotic pain-relievers
- History of substance abuse
- Simultaneous participation in other therapeutic trials
- Pregnant or breastfeeding
- Current severe psychiatric illness (e.g., schizophrenia, major depression with suicidal ideation)
- Condition that may make exposure to fMRI medically inadvisable
- Any condition that may prevent satisfactory completion of the study protocol
- Exclusion for Healthy Volunteers:
- Autoimmune or inflammatory disease (in addition to fibromyalgia) that causes pain (e.g., rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease)
- Having met the ACR criteria for FM
- Simultaneous participation in other therapeutic trials
- Pregnant or breastfeeding
- Current severe psychiatric illness (e.g., schizophrenia, major depression with suicidal ideation)
- Condition that may make exposure to fMRI medically inadvisable
- Any condition that may prevent satisfactory completion of the study protocol
- PET
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT00932061
Start Date
June 1 2008
End Date
December 1 2010
Last Update
July 30 2020
Active Locations (1)
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1
University of Michigan, Chronic Pain and Fatigue Research Center
Ann Arbor, Michigan, United States, 48106