Effectiveness of Acupuncture in Relieving Pain Due to Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional
Phase: Phase 1/Phase 2

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.
    

Intervention name(s): Acupuncture; Sham treatment
Intervention type(s): Device; Other
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: acupuncture; analgesia; pain; fibromyalgia; fMRI; PET