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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Georgia
Atlanta VA Medical and Rehab Center, Decatur, GA
RECRUITING
Decatur
Contact Information
Primary
Anna Woodbury, MD
Anna.Woodbury@va.gov
(404) 321-6111
Backup
Anna M Ree, BA
anna.ree@va.gov
(404) 321-6111
Time Frame
Start Date: 2024-11-01
Estimated Completion Date: 2028-11-01
Participants
Target number of participants: 240
Treatments
Active_comparator: True PENFS
Percutaneous electrical nerve stimulation applied to the ear x 4 over a 4 week period. The device is placed over the area of the ear and worn home continuously for a 5-day period, during which time it stimulates at a pre-set on/off duty cycle. At each in-person visit, the device is replaced until the device has been placed 4 times. The stimulation delivered is below the threshold of sensory perception.
Sham_comparator: Sham PENFS
A device is placed at the same points for the same amount of time and at the same intervals as the true device. This device will not deliver electrical stimulation.
Related Therapeutic Areas
Sponsors
Leads: VA Office of Research and Development

This content was sourced from clinicaltrials.gov