RECRUITING

Auricular Neuromodulation in Veterans With Fibromyalgia

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-11-01
Study Completion:2028-11-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06415591

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.

Ages Eligible for Study:20 Years to 60 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 20-60 years old (limit set to minimize brain structural changes due to aging).
  2. * Diagnosis of fibromyalgia by the American College of Rheumatology 2016 criteria.71
  3. * Right-handedness, to provide consistency in brain structure and function.
  4. * Pain score of 4 or greater on DVPRS53 in the 3 months prior to enrollment.
  5. * Intact skin in area of PENFS treatment
  6. * For those who elect to participate in the MRI portion, the ability to safely tolerate MRI
  1. * pregnancy
  2. * history of seizures or neurologic conditions that alter the brain
  3. * claustrophobia
  4. * MRI-incompatible implants, or other conditions incompatible with MRI (only for those who elect to perform MRI)
  5. * history of uncontrolled psychiatric illness
  6. * autoimmune disease that leads to pain
  7. * skin conditions that can increase risk of infection at PENFS site

Contacts and Locations

Study Contact

Anna Woodbury, MD
CONTACT
(404) 321-6111
Anna.Woodbury@va.gov
Anna M Ree, BA
CONTACT
(404) 321-6111
anna.ree@va.gov

Principal Investigator

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

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: VA Office of Research and Development

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-01
Study Completion Date2028-11-01

Study Record Updates

Study Start Date2024-11-01
Study Completion Date2028-11-01

Terms related to this study

Keywords Provided by Researchers

  • Pain
  • Fibromyalgia
  • Magnetic Resonance Imaging
  • Veterans
  • Percutaneous Electrical Nerve Field Stimulation
  • Vagus Nerve

Additional Relevant MeSH Terms

  • Fibromyalgia