Fibromyalgia
Conditions
Keywords
Fibromyalgia, Healthy controls, Acupuncture, Sham Acupuncture, fMRI, Biological marker
Brief summary
The hypothesis of this study is that biological markers are present in the body that are good indicators of chronic pain. Eligible participants will be assessed at baseline and after receiving a series of acupuncture or sham acupuncture (something that resembles, but is not, active acupuncture) sessions. If the subject qualifies for the investigators' research and are subsequently enrolled in this study, they will be randomly assigned (like the flip of a coin) to one of these two groups. Acupuncture, as previously shown by this group, leads to improvements in both clinical and evoked pain associated with fibromyalgia. The study involves two magnetic resonance imaging (MRI) brain scans, one at the beginning and one at the end of the study. Another optional portion of the study would involve 2 PET (positron emission tomography) scans of the subject's brain, one at the beginning and one at the end of the study; this type of scan allows us to get more specific information about the subject's brain function during an acupuncture session.
Interventions
Fibromyalgia subjects will be randomized to receive 9 acupuncture treatments over the course of four weeks. Subjects enrolled in the study may have 1) only fMRI or 2) fMRI scans and PET scans, depending on their eligibility criteria.
OTHERSham Treatment
Fibromyalgia subjects will be randomized to receive 9 sham treatments over the course of four weeks. Subjects enrolled in the study may have 1) only fMRI or 2) fMRI scans and PET scans, depending on their eligibility criteria.
Sponsors
The Dana Foundation
United States Department of Defense
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
Inclusion Criteria for Fibromyalgia Volunteers: * 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 * Be capable of giving written informed consent Inclusion Criteria for Healthy Volunteers: * Willing to refrain from alcohol intake for 48 hours prior to brain scans * Be right handed * Be capable of giving written informed consent PET Inclusion Criteria: * Willing to refrain from alcohol intake 48 hours prior to brain scans * Capable of giving written consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| fMRI signal | pre treatment - week 1 |
| PET signal | pre treatment - week 1 |
| H-MRS Glutamate | pre treatment - week 1 |
| H-MRS - Glutamate | post treatment - week 5 |
Secondary
| Measure | Time frame |
|---|---|
| Pain | pre treatment - week 1 |
Countries
United States
Outcome results
None listed