Clinical trial NCT00142597: Effectiveness of Acupuncture in Relieving Pain Due to Fibromyalgia
Official title: Mechanisms of Acupuncture Analgesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Fibromyalgia
Keywords: acupuncture
analgesia
pain
fibromyalgia
fMRI
PET
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2005-09-02
Enrollment: 46
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility 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
* Must be within driving distance of Ann Arbor, MI

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

Primary outcomes:
measure: Change in Mu-opioid Receptor Occupancy
timeFrame: measured from baseline to week 5
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Richard E. Harris, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.