Auricular neuromodulation for veterans with fibromyalgia
Auricular Neuromodulation in Veterans With Fibromyalgia: A Randomized, Sham-Controlled Study
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (Decatur, Georgia) |
| Trial ID | NCT06415591 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include veterans aged 18 and older with a diagnosis of fibromyalgia and a pain score of 4 or greater.
Not a fit: Patients who are pregnant, have a history of seizures or neurological conditions, or are claustrophobic may not benefit from this study.
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 performed: Previous studies have shown promising results for similar non-pharmacologic approaches, indicating potential for success in this trial.
Eligibility criteria
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 this trial is running
Decatur, Georgia
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.