Auricular Nerve Stimulation to Reduce Pain in Veterans with Fibromyalgia A Large Randomized Study

What this Trial Is About

Researchers are evaluating the use of percutaneous electrical nerve field stimulation PENFS, a FDA-approved acupuncture-like device applied to the external ear, in Veterans suffering from fibromyalgia. This chronic pain syndrome is difficult to treat and affects millions of Americans, including many Gulf War Veterans. The study aims to rigorously test PENFS effects on pain relief, physical function, and opioid withdrawal symptoms, while exploring brain activity changes and heart rate variability as possible mechanisms behind the treatment effects. Participants will be randomly assigned to receive either true PENFS or a sham device that looks identical but does not deliver electrical stimulation. The treatment involves placing the device on the ear for a 5-day continuous period once a week, repeated 4 times over 4 weeks. The true device stimulates below the sensory threshold. A subset of participants will undergo brain imaging using resting state functional connectivity MRI rs-fcMRI before and after treatment to identify neural changes and biomarkers related to PENFS effects. Heart rate variability will also be measured to assess vagal nerve involvement. During the study, participants will have assessments at baseline, 1 week, and 12 weeks post-treatment. These include self-reported pain scores, physical function tests like arm curls and chair stands, and questionnaires measuring fibromyalgia severity and patient-reported improvements. Brain scans and cardiopulmonary data will be collected for those qualifying for MRI. The main outcomes are improvements in clinical pain and analgesic use, with follow-up extending up to one year. Safety and adherence will be monitored throughout the trial.

Auricular Neuromodulation in Veterans With Fibromyalgia