RECRUITING

Auricular Neuromodulation in Veterans With Fibromyalgia

Description

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

Study Overview

Study Details

Study overview

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.

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

Auricular Neuromodulation in Veterans With Fibromyalgia

Condition
Fibromyalgia
Intervention / Treatment

-

Contacts and Locations

Decatur

Atlanta VA Medical and Rehab Center, Decatur, GA, Decatur, Georgia, United States, 30033-4004

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Age 20-60 years old (limit set to minimize brain structural changes due to aging).
  • * Diagnosis of fibromyalgia by the American College of Rheumatology 2016 criteria.71
  • * Right-handedness, to provide consistency in brain structure and function.
  • * Pain score of 4 or greater on DVPRS53 in the 3 months prior to enrollment.
  • * Intact skin in area of PENFS treatment
  • * For those who elect to participate in the MRI portion, the ability to safely tolerate MRI
  • * pregnancy
  • * history of seizures or neurologic conditions that alter the brain
  • * claustrophobia
  • * MRI-incompatible implants, or other conditions incompatible with MRI (only for those who elect to perform MRI)
  • * history of uncontrolled psychiatric illness
  • * autoimmune disease that leads to pain
  • * skin conditions that can increase risk of infection at PENFS site

Ages Eligible for Study

20 Years to 60 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

VA Office of Research and Development,

Anna Woodbury, MD, PRINCIPAL_INVESTIGATOR, Atlanta VA Medical and Rehab Center, Decatur, GA

Study Record Dates

2028-11-01