Auricular Neuromodulation in Veterans With Fibromyalgia
PENFS
2 other identifiers
interventional
240
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2024
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 8, 2024
CompletedFirst Posted
Study publicly available on registry
May 16, 2024
CompletedStudy Start
First participant enrolled
November 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2028
May 22, 2026
May 1, 2026
3.8 years
May 8, 2024
May 19, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Improvements in Clinical Pain (DVPRS)
The investigators will assess whether pain and functional improvements occur with the application of PENFS. Clinical pain, as measured by the Defense Veterans Pain Rating Scale (DVPRS), will be our primary outcome. This measure is rated on a scale of 0 to 10, with 0 being "no pain" and 10 being "as bad as it could be, nothing else matters". Assessments will be administered at baseline, immediately pre- and post-treatment (the device is replaced every 5 days for a total of 4 device applications), 12 weeks post-treatment, and 24 weeks post-treatment.
Through study completion, an average of 1 year
Improvements in Clinical Pain (Self-reported analgesic consumption)
The investigators will assess whether pain and functional improvements occur with the application of PENFS. Changes in clinical pain will also be assessed for this outcome via self-reported analgesic consumption. This measure is not rated on a scale - it is self-reported use. Assessments will be administered at baseline, immediately pre- and post-treatment (the device is replaced every 5 days for a total of 4 device applications), 12 weeks post-treatment, and 24 weeks post-treatment.
Through study completion, an average of 1 year
Secondary Outcomes (7)
PENFS effects on parasympathetic tone as measured by heart rate variability (HRV)
Baseline, 12 weeks post-treatment
Changes in Fibromyalgia Severity (FIQ-R)
Through study completion, an average of 1 year
Functional Improvements (Arm curls)
Through study completion, an average of 1 year
Changes in Fibromyalgia Severity (PSD)
Through study completion, an average of 1 year
Patient Reported Improvements (PROMIS change)
Through study completion, an average of 1 year
- +2 more secondary outcomes
Study Arms (2)
True PENFS
ACTIVE COMPARATORPercutaneous electrical nerve stimulation applied to the ear x 4 over a 4 week period. The device is placed over the area of the ear and worn home continuously for a 5-day period, during which time it stimulates at a pre-set on/off duty cycle. At each in-person visit, the device is replaced until the device has been placed 4 times. The stimulation delivered is below the threshold of sensory perception.
Sham PENFS
SHAM COMPARATORA device is placed at the same points for the same amount of time and at the same intervals as the true device. This device will not deliver electrical stimulation.
Interventions
FDA-approved 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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, 30033-4004, United States
Related Publications (1)
Vernon M, Rapsas B, Krishnamurthy LC, Krishnamurthy V, Stevens J, Woodbury A. Percutaneous Electrical Nerve Field Stimulation and White Matter Integrity in a Randomized Trial of Veterans With Fibromyalgia. Anesth Analg. 2026 May 1;142(5):1004-1008. doi: 10.1213/ANE.0000000000007785. Epub 2026 Apr 14. No abstract available.
PMID: 41134340DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anna Woodbury, MD
Atlanta VA Medical and Rehab Center, Decatur, GA
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Double-blind, sham placebo controlled. Randomization will be performed by a research coordinator, who will assign each participant a study number and keep a record of whether they are receiving true or sham PENFS, thus maintaining blinding of the participant, the study physicians, the research assistant, and the data analysis team including the P.I. (A.W.) until completion of the follow-up period and data analyses can be performed.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 8, 2024
First Posted
May 16, 2024
Study Start
November 1, 2024
Primary Completion (Estimated)
September 1, 2028
Study Completion (Estimated)
November 1, 2028
Last Updated
May 22, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share