Auricular neuromodulation for veterans with fibromyalgia
Official title: Auricular Neuromodulation in Veterans With Fibromyalgia: A Randomized, Sham-Controlled Study
Run by VA Office of Research and Development · NCT06415591 · Data updated 2026-11-12
This study is testing if a new ear-based treatment can help veterans with fibromyalgia feel less pain and move better compared to a fake treatment.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 240 (estimated) |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (Decatur, Georgia) |
| Status | Recruiting |
| Started | November 1, 2024 |
| Main results expected | September 1, 2028 |
| Study ends | November 1, 2028 |
| Registry record updated | May 22, 2026 |
| Trial ID | NCT06415591 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include veterans aged 18 and older with a diagnosis of fibromyalgia and a pain score of 4 or greater.
✕Probably not a fit
Patients who are pregnant, have a history of seizures or neurological conditions, or are claustrophobic may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the effectiveness of percutaneous electrical nerve field stimulation (PENFS), a non-pharmacologic therapy, in treating fibromyalgia among veterans. The approach targets cranial nerve branches through the external ear to alleviate pain and improve physical function. The study will utilize resting state functional connectivity MRI to assess changes in brain activity associated with treatment. By comparing PENFS to a sham treatment, the study aims to rigorously test its efficacy and understand the underlying mechanisms of its effects.
Why it matters
Potential benefit: If successful, this treatment could significantly improve pain management and quality of life for veterans suffering from fibromyalgia.
How similar studies have gone: Previous studies have shown promising results for similar non-pharmacologic approaches, indicating potential for success in this trial.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Pregnancy (self-reported) * History of seizures or neurologic conditions that alter the brain * Claustrophobia, MRI-incompatible implants, or other conditions incompatible with MRI (only for those who participate in MRI) * History of uncontrolled psychiatric illness, autoimmune disease that leads to pain, or skin conditions that can increase risk of infection at PENFS site
Where it's running
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Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, United States Recruiting
Study contacts
- Principal investigator: Anna Woodbury, MD — Atlanta VA Medical and Rehab Center, Decatur, GA
- Study coordinator: Anna Woodbury, MD
- Email: Anna.Woodbury@va.gov
- Phone: (404) 321-6111
Similar studies
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.