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| ID | Type | Description | Link |
|---|---|---|---|
| K01AT001111-01 | U.S. NIH Grant/Contract | View source | |
| 1K01AT001111-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
This study will determine the effectiveness of acupuncture versus a placebo in altering brain activity and relieving pain due to fibromyalgia.
Fibromyalgia is one of the most common rheumatic diseases, second only to osteoarthritis. It causes chronic muscle pain and fatigue. Acupuncture functions by targeting specific nerve pathways to different organs or parts of the body. Research has shown that acupuncture is effective in decreasing or eliminating people's sensitivity to pain in targeted regions. However, some believe that the reduction in pain is due to a placebo response rather than acupuncture itself. This study will use two brain-imaging techniques to determine the brain response to acupuncture versus a simulation of acupuncture, thereby assessing whether acupuncture is actually effective in relieving pain.
Participants in this single-blind study will be randomly assigned to receive either acupuncture or a placebo treatment. The placebo will consist of a simulation of acupuncture. Functional magnetic resonance imaging (fMRI) and positron emission tomography (PET) will be used to assess activity of brain mu-opioid receptors. These receptors are involved in the body's ability to perceive pain. All participants will be scanned twice using the fMRI scanner, once before any treatment sessions and once at the conclusion of all treatment sessions. Both fMRI sessions will involve applying pressure to the thumb to elicit a response in the brain in order to assess the corresponding fMRI blood oxygen level dependent (BOLD) signal and whether this activation changes after treatment intervention. Participants will then receive nine treatments of acupuncture or placebo outside the scanner over a 4-week period. The PET portion of this study is optional, and, if you elect to participate, your first treatment session will be performed in the PET scanner. After this first session, participants will have seven additional treatment sessions outside of the scanner over a 4-week period. The last session will be performed in the PET scanner to assess changes in mu-opioid receptor activity that may have occurred over the 4 weeks. A baseline visit to determine eligibility and a close-out visit at week 8 are also part of the participation schedule. It is very important that participants live within driving distance of Ann Arbor, MI due to the significant number of visits to our Center.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Traditional Acupuncture | Active Comparator | Acupuncture sites will be used for active intervention. |
|
| Sham Treatment | Sham Comparator | Sham acupuncture is used. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture | Device | Involves the insertion and manual stimulation of thin acupuncture needles into specific points in the body. Fibromyalgia participants will be randomized to receive 9 acupuncture treatments over the course of four weeks. All participants will be scanned twice using the fMRI scanner. The PET portion of the study is optional. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mu-opioid Receptor Occupancy | Here we report the change (post - pre) in mu-opioid receptor binding potential (BP) for the perigenual anterior cingulate. BP is a unitless measure and reflects the total maximum binding of receptors divided by the dissociation constant. BP = Bmax/Kd. | measured from baseline to week 5 |
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Inclusion Criteria:
fMRI Inclusion Criteria:
PET Inclusion Criteria:
Exclusion Criteria:
fMRI Exclusion Criteria:
PET Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard E. Harris, PhD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18311814 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Traditional Acupuncture | Acupuncture sites will be used for active intervention. Acupuncture: Involves the insertion and manual stimulation of thin acupuncture needles into specific points in the body. Fibromyalgia participants will be randomized to receive 9 acupuncture treatments over the course of four weeks. All participants will be scanned twice using the fMRI scanner. The PET portion of the study is optional. |
| FG001 | Sham Treatment | Sham acupuncture is used. Sham treatment: Fibromyalgia participants will be randomized to receive 9 sham treatments over the course of four weeks. All participants will be scanned twice using the fMRI scanner. The PET portion of the study is optional. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Traditional Acupuncture | Acupuncture sites will be used for active intervention. Acupuncture: Involves the insertion and manual stimulation of thin acupuncture needles into specific points in the body. Fibromyalgia participants will be randomized to receive 9 acupuncture treatments over the course of four weeks. All participants will be scanned twice using the fMRI scanner. The PET portion of the study is optional. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Mu-opioid Receptor Occupancy | Here we report the change (post - pre) in mu-opioid receptor binding potential (BP) for the perigenual anterior cingulate. BP is a unitless measure and reflects the total maximum binding of receptors divided by the dissociation constant. BP = Bmax/Kd. | Posted | Mean | Standard Deviation | Unitless: binding potential is Bmax/Kd | measured from baseline to week 5 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Traditional Acupuncture | Acupuncture sites will be used for active intervention. Acupuncture: Involves the insertion and manual stimulation of thin acupuncture needles into specific points in the body. Fibromyalgia participants will be randomized to receive 9 acupuncture treatments over the course of four weeks. All participants will be scanned twice using the fMRI scanner. The PET portion of the study is optional. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Richard E. Harris | University of Michigan | 734-998-6996 | reharris@med.umich.edu |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| D000377 | Agnosia |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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|
| Sham treatment | Other | Fibromyalgia participants will be randomized to receive 9 sham treatments over the course of four weeks. All participants will be scanned twice using the fMRI scanner. The PET portion of the study is optional. |
|
| BG001 | Sham Treatment | Sham acupuncture is used. Sham treatment: Fibromyalgia participants will be randomized to receive 9 sham treatments over the course of four weeks. All participants will be scanned twice using the fMRI scanner. The PET portion of the study is optional. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Sham Treatment |
Sham acupuncture is used. Sham treatment: Fibromyalgia participants will be randomized to receive 9 sham treatments over the course of four weeks. All participants will be scanned twice using the fMRI scanner. The PET portion of the study is optional. |
|
|
| 0 |
| 23 |
| 0 |
| 23 |
| EG001 | Sham Treatment | Sham acupuncture is used. Sham treatment: Fibromyalgia participants will be randomized to receive 9 sham treatments over the course of four weeks. All participants will be scanned twice using the fMRI scanner. The PET portion of the study is optional. | 0 | 23 | 0 | 23 |
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| D009422 |
| Nervous System Diseases |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |