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Sponsors and Collaborators: |
University of Michigan The Dana Foundation Department of Defense |
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Information provided by: | University of Michigan |
ClinicalTrials.gov Identifier: | NCT00932061 |
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 series of acupuncture or "sham" acupuncture (something that resembles, but is not, active acupuncture) sessions. If the subject qualifies for the investigators' research and are subsequently enrolled in this study, they will be randomly assigned (like the flip of a coin) to one of these two groups. Acupuncture, as previously shown by this group, leads to improvements in both clinical and evoked pain associated with fibromyalgia. The study involves two magnetic resonance imaging (MRI) brain scans, one at the beginning and one at the end of the study. Another optional portion of the study would involve 2 PET (positron emission tomography) scans of the subject's brain, one at the beginning and one at the end of the study; this type of scan allows us to get more specific information about the subject's brain function during an acupuncture session.
Condition | Intervention |
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Fibromyalgia |
Other: Traditional Acupuncture Other: Sham Treatment |
Study Type: | Interventional |
Study Design: | Diagnostic, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment |
Official Title: | Developing Biomarkers for Fibromyalgia |
Estimated Enrollment: | 60 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | May 2010 |
Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Traditional Acupuncture: Active Comparator
Acupuncture sites will be used for active intervention.
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Other: Traditional Acupuncture
Fibromyalgia subjects will be randomized to receive 9 acupuncture treatments over the course of four weeks. Subjects enrolled in the study may have 1) only fMRI or 2) fMRI scans and PET scans, depending on their eligibility criteria.
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Sham Treatment: Sham Comparator
Sham acupuncture is used.
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Other: Sham Treatment
Fibromyalgia subjects will be randomized to receive 9 sham treatments over the course of four weeks. Subjects enrolled in the study may have 1) only fMRI or 2) fMRI scans and PET scans, depending on their eligibility criteria. |
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Inclusion Criteria for Fibromyalgia Volunteers:
Inclusion Criteria for Healthy Volunteers:
PET Inclusion Criteria:
Exclusion Criteria:
Exclusion Criteria for Fibromyalgia Volunteers:
Exclusion for Healthy Volunteers:
PET Exclusion Criteria:
Contact: Craig Urwin, B.S | 734-998-7023 | craijose@umich.edu |
Contact: Katherine Scott, BSN | 734-998-7022 | jrsj@umich.edu |
United States, Michigan | |
University of Michigan, Chronic Pain and Fatigue Research Center | Recruiting |
Ann Arbor, Michigan, United States, 48106 | |
Contact: Craig Urwin, B.S. 734-998-7023 craijose@umich.edu | |
Contact: Katherine Scott, BSN 734-998-7022 jrsj@umich.edu | |
Principal Investigator: Richard Harris, Ph.D. |
Principal Investigator: | Richard Harris, Ph.D. | Univeristy of Michigan, Chronic Pain & Fatigue Research Center |
Responsible Party: | Chronic Pain and Fatigue Research Center ( Richard Harris, Ph.D. ) |
Study ID Numbers: | Hum 00010061, F017513, Sponsor(DOD) W81XWH-07-20050 |
Study First Received: | June 25, 2009 |
Last Updated: | July 1, 2009 |
ClinicalTrials.gov Identifier: | NCT00932061 History of Changes |
Health Authority: | United States: Institutional Review Board |
Fibromyalgia Healthy controls Acupuncture |
Sham Acupuncture fMRI Biological marker |
Muscular Diseases Neuromuscular Diseases Musculoskeletal Diseases Myofascial Pain Syndromes |
Fibromyalgia Pain Healthy Rheumatic Diseases |
Muscular Diseases Neuromuscular Diseases Musculoskeletal Diseases Myofascial Pain Syndromes |
Fibromyalgia Nervous System Diseases Rheumatic Diseases |