Actively Recruiting
Auricular Neuromodulation in Veterans With Fibromyalgia
Led by VA Office of Research and Development · Updated on 2026-02-27
240
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Auricular Neuromodulation in Veterans With Fibromyalgia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- For MRI participants, age 20-60 years old
- For MRI participants, right-handedness
- Ability to safely tolerate MRI (for MRI participants)
- Diagnosis of fibromyalgia by American College of Rheumatology 2016 criteria
- Pain score of 4 or greater on DVPRS in the 3 months before enrollment
- Intact skin in the area of PENFS treatment
You will not qualify if you...
- Pregnancy (self-reported)
- History of seizures or neurological conditions that alter the brain
- Claustrophobia, MRI-incompatible implants, or conditions incompatible with MRI (for MRI participants)
- History of uncontrolled psychiatric illness
- Autoimmune diseases causing pain
- Skin conditions that increase infection risk at PENFS site
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, United States, 30033-4004
Actively Recruiting
Research Team
A
Anna Woodbury, MD
CONTACT
A
Anna M Ree, BA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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