This study will determine the effectiveness of acupuncture versus a placebo in altering brain activity and relieving pain due to fibromyalgia.

Condition	Intervention	Phase
Fibromyalgia	Device: Acupuncture	Phase I Phase II

Further Study Details: 

Primary Outcomes: Change in mu-opioid receptor occupancy; measured from baseline to Week 5; Change in fMRI BOLD signal; measured from baseline to Week 5
Secondary Outcomes: Change in clinical pain as assessed by the McGill Pain Questionnaire; measured from baseline to Week 5
Expected Total Enrollment:  80

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 placebo. The placebo will consist of a simulation of acupuncture, performed with a toothpick. 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. 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. 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. 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. 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. After this first session, participants will have 7 additional treatment sessions outside of the scanner over a 4-week period. 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.

Ages Eligible for Study:  18 Years   -   75 Years,  Genders Eligible for Study:  Female

Criteria

Inclusion Criteria:

fMRI Inclusion Criteria:

• 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

PET Inclusion Criteria:

• Meets fMRI inclusion criteria
• Willing to refrain from alcohol intake for 48 hours prior to PET studies

Exclusion Criteria:

fMRI Exclusion Criteria:

• 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

PET Exclusion Criteria:

• Meets any of the fMRI exclusion criteria
• Current major depression
• Condition that may make exposure to PET medically inadvisable

Please refer to this study by ClinicalTrials.gov identifier  NCT00142597

Ginny Leone      734-998-7110    vgracely@umich.edu

Michigan
      University of Michigan, Ann Arbor,  Michigan,  48109,  United States; Recruiting

Study chairs or principal investigators

Richard E. Harris, PhD,  Principal Investigator,  University of Michigan   

Study ID Numbers:  1-K01-AT01111-01; 1-K01-AT01111-01
Last Updated:  September 1, 2005
Record first received:  September 1, 2005
ClinicalTrials.gov Identifier:  NCT00142597
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-09-06