Auricular Neuromodulation in Veterans With Fibromyalgia
Recruiting · NCT06415591 · Interventional (participants receive a specific treatment) · Lead sponsor: VA Office of Research and Development
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
Inclusion criteria
- Age 18 years or older; for those who participate in the MRI portion, age 20-60 years old (limit specifically set for participants receiving an MRI scan; limit set to minimize brain structural changes due to aging)
- For those who participate in the MRI portion, right-handedness, to provide consistency in brain structure and function (limit specifically set for participants receiving an MRI scan; limit set to minimize brain structural changes due to aging)
- For those who participate in the MRI portion, the ability to safely tolerate MRI
- Diagnosis of fibromyalgia by the American College of Rheumatology 2016 criteria69
- Pain score of 4 or greater on DVPRS51 in the 3 months prior to enrollment
- Intact skin in area of PENFS treatment
Exclusion criteria
- Pregnancy (self-reported)
- History of seizures or neurologic conditions that alter the brain
- Claustrophobia, MRI-incompatible implants, or other conditions incompatible with MRI (only for those who participate in MRI)
- History of uncontrolled psychiatric illness, autoimmune disease that leads to pain, or skin conditions that can increase risk of infection at PENFS site
Where it is running
1 location listed across 1 US state.
- Atlanta VA Medical and Rehab Center, Decatur, GA - Decatur, Georgia, United States