Feasibility Study: fMRI Evaluation of Auricular PENFS for Fibromyalgia

Completed · Not applicable

Conditions studied: Fibromyalgia

In brief

Given recent increasing opioid-related deaths and evidence showing against the use of opioids for non-malignant chronic pain, there is growing need for non-narcotic pain management. Fibromyalgia is a difficult to treat chronic pain condition that is often treated with opioids despite existing evidence. The prevalence of fibromyalgia is increased among Veterans returning from the gulf war and is already a significant burden in senior Veterans who may have suffered with chronic pain for decades already. Many treatment options for fibromyalgia carry intolerable side effects. PENFS (percutaneous electrical neural field stimulation) is a FDA-approved, non-pharmacologic therapy that is currently utilized within the military and VA system, but sufficient evidence regarding its outcomes and neural mechanisms have not been adequately investigated. An understanding of its neural underpinnings and analgesic effects could lead to 1) improvements in pain management and quality of life, 2) cost-savings and 3) development of new techniques to address pain.

Key facts

Study ID

NCT03008837

Run by

VA Office of Research and Development

People needed

27

Starts

2017-06-01

Expected to finish

2019-05-31

Last updated by the study team

2020-07-27

Who can join

Age: 20 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects must be male and female Veterans age 20-60 with a diagnosis of fibromyalgia as diagnosed by a clinician, by chart review, and by the most recent American College of Rheumatology 2010 criteria for the diagnosis of fibromyalgia. 70,71
• Subjects must self-report consistent, daily pain (greater than 5 on the VAS) >90 days.
• Subjects must have intact skin free of infection at the site of implantation.
• Subjects must be willing to participate and understand the consent.
• Subjects must be right-handed in order to provide consistency in brain structure and function.

You may not qualify if…

• Subjects must not be currently pregnant, since effects of fMRI and electrical current on the developing fetus are not well-known.
• Subjects must not have an implanted electrical device such as a vagal stimulator, pacemaker, or spinal pain pump, which are not compatible with MRI.
• Subjects must not have a history of seizures or neurologic condition that may alter the structure of the brain.
• Subjects must not have a history of drug abuse or severe, uncontrolled psychiatric illness such as schizophrenia or major depressive disorder with suicidal ideation.
• Subjects must not have psoriasis vulgaris or other skin conditions that may increase the risk of infection at the implantation site.
• Subjects must not have severe anxiety, claustrophobia, or other conditions that may prevent their ability to lie at rest in an MRI scanner. This will be determined after discussion with the patient regarding their own perceived ability to lie at rest in an MRI scanner without the use of additional sedating medications.
• Subjects must not introduce new medications or treatments for fibromyalgia symptoms during the course of the study to prevent confounding results.
• Subjects must not have a concurrent autoimmune or inflammatory disease that causes pain such as systemic lupus erythematosus, inflammatory bowel disease or rheumatoid arthritis, since this could decrease the effect of treatment.

Where it is running

• Atlanta VA Medical and Rehab Center, Decatur, GA — Decatur, Georgia, United States

Full record on ClinicalTrials.gov

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