Fibromyalgia
Conditions
Keywords
acupuncture, analgesia, pain, fibromyalgia, fMRI, PET
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.
Interventions
DEVICEAcupuncture
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.
OTHERSham 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.
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Mu-opioid Receptor Occupancy | measured from baseline to week 5 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 23 |
| 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. | 23 |
| Total | 46 |
Baseline characteristics
| Characteristic | Total | Traditional Acupuncture | Sham Treatment |
|---|---|---|---|
| Age, Continuous | 46.70 years STANDARD_DEVIATION 13.95 | 48.52 years STANDARD_DEVIATION 12.85 | 44.87 years STANDARD_DEVIATION 15.03 |
| Region of Enrollment United States | 46 participants | 23 participants | 23 participants |
| Sex: Female, Male Female | 46 Participants | 23 Participants | 23 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 23 | 0 / 23 |
| serious Total, serious adverse events | 0 / 23 | 0 / 23 |
Outcome results
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.
Time frame: measured from baseline to week 5
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Traditional Acupuncture | Change in Mu-opioid Receptor Occupancy | 0.2352 Unitless: binding potential is Bmax/Kd | Standard Deviation 0.1911 |
| Sham Treatment | Change in Mu-opioid Receptor Occupancy | .0015 Unitless: binding potential is Bmax/Kd | Standard Deviation 0.1197 |