Michigan Trial of Acupuncture Effect on FM Pain Now Recruiting

A study to investigate the mechanisms by which acupuncture might relieve pain due to Fibromyalgia is recruiting diagnosed adult female FM patients who suffer pain at least 50 percent of days; have not previously undergone acupuncture therapy; and are located within about 1 – !/2 hours’ traveling distance of Ann Arbor, Michigan.

The study (ClinicalTrials.gov number NCT00142597) is being conducted by researchers at the University of Michigan’s Chronic Pain and Fatigue Research Center and is sponsored the National Center for Complementary and Alternative Medicine (NCCAM). Its objective: to “Determine the effectiveness of acupuncture versus a placebo [simulated acupuncture] in altering brain activity and relieving pain due to Fibromyalgia” – and possibly “lead to acupuncture’s acceptance by the Western medical and scientific communities as a practical treatment option.”

Study details, basic eligibility guidelines, specifics of the multiple inclusion & exclusion criteria, and contact information for interested patients are as follows.

Study Objectives & Design

As the investigators, led by Principal Investigator Richard E. Harris, PhD, explain it:
n 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.
n 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.
n Participants in this single-blind study will be randomly assigned to receive either acupuncture or placebo. The placebo will consist of a simulation of acupuncture, performed with a toothpick.
n Functional magnetic resonance imaging (fMRI) and positron emission tomography (PET) will be used to assess activity of the mu-opioid receptors. These receptors are located in the brain and are involved in the body’s ability to perceive pain. All participants will be scanned using the fMRI scanner. Only those participants who meet certain inclusion criteria will also receive a PET scan.
n Participants who do qualify, however, may elect not to receive a PET scan. Participants’ assigned treatments will be performed while they are inside the scanner.
n Baseline measures during the initial fMRI session will involve applying pressure to the thumb to elicit a pain response in the brain and assessing the corresponding fMRI blood oxygen level dependent (BOLD) signal.
n Participants will then receive 9 treatments of acupuncture or placebo outside the scanner over a 4-week period. The final session will be performed in the fMRI scanner to assess changes in the BOLD signal over the 4 weeks.
n During the first session in the PET scanner, baseline measurements will determine brain activity prior to the intervention. Participants will then receive their assigned treatments while in the scanner.
n After this first session, participants will have 7 additional treatment sessions outside of the scanner over a 4-week period.
n The last session will be performed in the scanner to assess changes in mu-opioid receptor activity that may have occurred over the 4 weeks.”

Eligibility Guidelines
Female FM patients between the ages of 18 and 75 may be eligible to participate in this study.

Inclusion Criteria for fMRI
1. Has met American College of Rheumatology (1990) criteria for the diagnosis of Fibromyalgia for at least 1 year
2. Chronic pain more than 50% of days
3. Willing to limit introduction of any new medications or treatments for fibromyalgia during the study
4. Able to attend study visits up to three times weekly
5. Right-handed

Inclusion Criteria for PET
1. Meets fMRI inclusion criteria
2. Willing to refrain from alcohol intake for 48 hours prior to PET studies

Exclusion Criteria for fMRI
Factors that will rule out participation include:
1. Knowledge that could prevent "blinding" of the participant to the study interventions (including previous acupuncture treatment)
2. Presence of a known coagulation abnormality, thrombocytopenia, or bleeding diathesis that may preclude the safe use of acupuncture
3. Autoimmune or inflammatory disease (in addition to fibromyalgia) that causes pain (e.g., rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease)
4. Daily use of narcotic pain-relievers
5. History of substance abuse
6. Simultaneous participation in other therapeutic trials
7. Pregnant or breastfeeding
8. Current severe psychiatric illness (e.g., schizophrenia, major depression with suicidal ideation)
9. Condition that may make exposure to fMRI medically inadvisable
10. Any condition that may prevent satisfactory completion of the study protocol

Exclusion Criteria for PET
Factors that will rule out participation include:
1. Meets any of the fMRI exclusion criteria
2. Current major depression
3. Condition that may make exposure to PET medically inadvisable.

Contact Information & Location
Contact Ginny Leone at 734-998-7110 or e-mail vgracely@umich.edu
Please refer to this study by ClinicalTrials.gov identifier NCT00142597

Study ID Numbers: K01 AT01111-01; 1-K01-AT01111-01
Health Authority: United States: Federal Government

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