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Auricular Neuromodulation in Veterans With Fibromyalgia
Sponsor: VA Office of Research and Development
Summary
PENFS (percutaneous electrical nerve field stimulation) is an FDA-cleared acupuncture-like therapy applied to the external ear targeting several cranial nerve branches including the auricular branch of the vagus nerve to improve pain, physical function, and reduce symptoms of opioid withdrawal. PENFS has been previously shown to provide improvements in fibromyalgia, a difficult to treat chronic pain syndrome, which correlate with changes observed using a special kind of MRI called resting state functional connectivity MRI (rs-fcMRI) that evaluates brain activity at rest. The goals of this study are to rigorously test the initial promising results of PENFS in a much larger group of Veterans suffering from fibromyalgia and to identify potential mechanisms of PENFS effects. Further developing non-pharmacologic therapies for pain can help to improve quality of life and function for those suffering from fibromyalgia and decrease reliance on opioids and other drugs that have numerous side effects for individuals suffering from chronic pain.
Official title: Auricular Neuromodulation in Veterans With Fibromyalgia: A Randomized, Sham-Controlled Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
240
Start Date
2024-11-01
Completion Date
2028-11-01
Last Updated
2026-02-27
Healthy Volunteers
No
Conditions
Interventions
Percutaneous electrical nerve field stimulation
FDA-approved acupuncture-like therapy applied to the external ear targeting several cranial nerve branches including the auricular branch of the vagus nerve to improve pain, physical function, and reduce symptoms of opioid withdrawal.
Locations (1)
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, United States