Auricular Neuromodulation in Veterans With Fibromyalgia, A Randomized, Sham-Controlled Study - Trial NCT06415591

Timeline & Enrollment

Primary Outcome

Improvements in Clinical Pain (DVPRS),Improvements in Clinical Pain (Self-reported analgesic consumption)

Summary

PENFS (percutaneous electrical nerve field stimulation) is an 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. 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.

ICD-10 Classifications