Auricular Neuromodulation in Veterans With Fibromyalgia

Part of paid clinical trials in Decatur, Georgia.

Sponsor
VA Office of Research and Development
Study ID
NCT06415591
Status
Recruiting
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Conditions

  • Fibromyalgia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Percutaneous electrical nerve field stimulation — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Nov 1, 2024
Status verified
May 2026
Primary completion
Sep 1, 2028
Completion
Nov 1, 2028

Study Design

Enrollment
240 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: True PENFS
    Percutaneous 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 Comparator: Sham PENFS
    A 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.

Primary Outcome Measure

Improvements in Clinical Pain (DVPRS) [ Time Frame: Through study completion, an average of 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Atlanta VA Medical and Rehab Center, Decatur, GADecaturGeorgia30033-4004
Anna Woodbury, MD
[email protected]
404-321-6111
Anna Woodbury, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Decatur, GA

By research site
Atlanta VA Medical and Rehab Center, Decatur, GA· Decatur, GA

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