Percutaneous Electrical Nerve Field Stimulation and White Matter Integrity in a Randomized Trial of Veterans With Fibromyalgia.
Mark Vernon, Benjamin Rapsas, Lisa C Krishnamurthy...
https://pubmed.ncbi.nlm.nih.gov/41134340Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID06415591
Auricular Neuromodulation in Veterans With Fibromyalgia: A Randomized, Sham-Controlled Study
Led by VA Office of Research and Development · Updated on 2026-05-22
240
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of percutaneous electrical nerve field stimulation (PENFS), a FDA-approved acupuncture-like device applied to the external ear, in Veterans suffering from fibromyalgia. This chronic pain syndrome is difficult to treat and affects millions of Americans, including many Gulf War Veterans. The study aims to rigorously test PENFS effects on pain relief, physical function, and opioid withdrawal symptoms, while exploring brain activity changes and heart rate variability as possible mechanisms behind the treatment effects. Participants will be randomly assigned to receive either true PENFS or a sham device that looks identical but does not deliver electrical stimulation. The treatment involves placing the device on the ear for a 5-day continuous period once a week, repeated 4 times over 4 weeks. The true device stimulates below the sensory threshold. A subset of participants will undergo brain imaging using resting state functional connectivity MRI (rs-fcMRI) before and after treatment to identify neural changes and biomarkers related to PENFS effects. Heart rate variability will also be measured to assess vagal nerve involvement. During the study, participants will have assessments at baseline, 1 week, and 12 weeks post-treatment. These include self-reported pain scores, physical function tests like arm curls and chair stands, and questionnaires measuring fibromyalgia severity and patient-reported improvements. Brain scans and cardiopulmonary data will be collected for those qualifying for MRI. The main outcomes are improvements in clinical pain and analgesic use, with follow-up extending up to one year. Safety and adherence will be monitored throughout the trial.
CONDITIONS
Brief Title
Auricular Neuromodulation in Veterans With Fibromyalgia
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosis of fibromyalgia by the American College of Rheumatology 2016 criteria
- Pain score of 4 or greater on Defense and Veterans Pain Rating Scale in the 3 months prior to enrollment
- Intact skin in area of PENFS treatment
- For MRI participants: age 20-60 years old
- For MRI participants: right-handedness
- For MRI participants: ability to safely tolerate MRI
You will not qualify if you...
- Pregnancy (self-reported)
- History of seizures or neurologic conditions that alter the brain
- Claustrophobia, MRI-incompatible implants, or other conditions incompatible with MRI (for MRI participants)
- History of uncontrolled psychiatric illness
- Autoimmune disease that leads to pain
- Skin conditions that can increase risk of infection at PENFS site
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 4 weeks
Participants receive either true or sham auricular percutaneous electrical nerve field stimulation (PENFS) applied to the ear once weekly for 4 weeks. The device is worn continuously for 5 days each week and replaced at each weekly visit.
4 weekly visits (in-person)
Follow-up
Duration - 12 weeks post-treatment
Participants are assessed for clinical pain, physical function, and neural changes at 1 and 12 weeks after completing treatment. A subset undergoes brain imaging and heart rate variability measurements to evaluate treatment effects.
2 visits (in-person) at 1 and 12 weeks post-treatment
Trial Site Locations
Total: 1 location
1
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, United States, 30033-4004
Actively Recruiting
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Research Team
A
Anna Woodbury, MD
A
Anna M Ree, BA
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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