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| ID | Type | Description | Link |
|---|---|---|---|
| F017513 | |||
| Sponsor(DOD) W81XWH-07-20050 |
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| Name | Class |
|---|---|
| The Dana Foundation | OTHER |
| United States Department of Defense | FED |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Traditional Acupuncture | Active Comparator | Acupuncture sites will be used for active intervention. |
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| Sham Treatment | Sham Comparator | Sham acupuncture is used. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Traditional Acupuncture | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| fMRI signal | pre treatment - week 1 | |
| PET signal | pre treatment - week 1 | |
| H-MRS Glutamate | pre treatment - week 1 | |
| fMRI signal | post treatment - week 5 | |
| PET signal | post treatment - week 5 | |
| H-MRS - Glutamate | post treatment - week 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Pain | pre treatment - week 1 | |
| Pain | post treatment - week 5 |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Harris, Ph.D. | Univeristy of Michigan, Chronic Pain & Fatigue Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan, Chronic Pain and Fatigue Research Center | Ann Arbor | Michigan | 48106 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19501658 | Result | Harris RE, Zubieta JK, Scott DJ, Napadow V, Gracely RH, Clauw DJ. Traditional Chinese acupuncture and placebo (sham) acupuncture are differentiated by their effects on mu-opioid receptors (MORs). Neuroimage. 2009 Sep;47(3):1077-85. doi: 10.1016/j.neuroimage.2009.05.083. Epub 2009 Jun 6. | |
| 18311814 | Result | Harris RE, Sundgren PC, Pang Y, Hsu M, Petrou M, Kim SH, McLean SA, Gracely RH, Clauw DJ. Dynamic levels of glutamate within the insula are associated with improvements in multiple pain domains in fibromyalgia. Arthritis Rheum. 2008 Mar;58(3):903-7. doi: 10.1002/art.23223. |
| Label | URL |
|---|---|
| Chronic Pain and Fatigue Research Center | View source |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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| Sham Treatment | Other | 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. |
|
| 17855614 | Result | Harris RE, Clauw DJ, Scott DJ, McLean SA, Gracely RH, Zubieta JK. Decreased central mu-opioid receptor availability in fibromyalgia. J Neurosci. 2007 Sep 12;27(37):10000-6. doi: 10.1523/JNEUROSCI.2849-07.2007. |
| 19790053 | Result | Harris RE, Sundgren PC, Craig AD, Kirshenbaum E, Sen A, Napadow V, Clauw DJ. Elevated insular glutamate in fibromyalgia is associated with experimental pain. Arthritis Rheum. 2009 Oct;60(10):3146-52. doi: 10.1002/art.24849. |
| 20506181 | Result | Napadow V, LaCount L, Park K, As-Sanie S, Clauw DJ, Harris RE. Intrinsic brain connectivity in fibromyalgia is associated with chronic pain intensity. Arthritis Rheum. 2010 Aug;62(8):2545-55. doi: 10.1002/art.27497. |
| D009422 |
| Nervous System Diseases |