Feasibility Study: fMRI Evaluation of Auricular PENFS for Fibromyalgia

NCT03008837 | Completed Results FDA Device

• 2 other identifiers: F2113-M1IK1RX002113-01A2
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fibromyalgia

Outcome Measures

Primary Outcomes (1)

• fcMRI as a Biomarker to Investigate Functionally Correlated Neural Substrates of Pain in Patients Undergoing PENFS

  2 weeks following the final treatment, subjects in the PENFS group were be evaluated for changes in functional connectivity between the right posterior insula seed and other areas of the DMN as evaluated by fcMRI relative to standard treatment controls, using whole brain analysis. The measurement is increase/decrease of signal in a given region, thresholded at p \<0.05, summarized into a value representing 'size of region of increase' or 'size of region of decrease' after subjects scans were combined/mapped onto a standard MNI brain. Only clusters of over 40 voxels were included, and the size of the region is reported in voxel size. The averaged brains for baseline fcMRI was subtracted from post-treatment for each group, and then these averaged differences were subtracted from each other. While other areas of the brain met threshold criteria in the analysis, only areas belonging to the DMN are reported.

  baseline and 2 weeks post-treatment

Secondary Outcomes (5)

• Change in Defense Veterans Pain Rating Scale (DVPRS) From Baseline

  2, 6 and 12 weeks follow-up

• Change in Pain Interference With "Activity," "Sleep," "Mood", and "Stress" From Baseline

  2, 6 and 12 weeks follow-up

• Change in Number of Bicep Curls From Baseline (Left Arm)

  2, 6 and 12 weeks follow-up

• Change in Number of Bicep Curls From Baseline (Right Arm)

  2, 6 and 12 weeks follow-up

• Change in Sit-to Stand Test From Baseline

  2, 6 and 12 weeks follow-up

Study Arms (2)

PENFS

EXPERIMENTAL

Veterans with fibromyalgia who meet study criteria and are randomized to the experimental group will receive standard therapy in addition to percutaneous electrical neural field stimulation (PENFS), which involves placement of small electrodes through a similar process to ear acupuncture to the ear. These electrodes are attached to a battery pack that is taped behind the ear and worn for 5-day intervals. The intention of this FDA-approved device is to relieve pain, though data on its effectiveness is still limited. Device placement (series of 4, weekly) will be performed by an Anesthesiology Pain Clinic provider. fMRI evaluation of neural changes, assessment of function and quality of life improvements will be performed at the beginning and end of the study.

Device: Military Field Stimulator

Standard Therapy

ACTIVE COMPARATOR

Veterans with fibromyalgia who meet study criteria and are randomized to standard therapy will receive physical therapy, medication management through the Anesthesiology Pain Clinic, and referral to a pain psychologist. fMRI evaluation of neural changes, assessment of function and quality of life improvements will be performed at the beginning and end of the study.

Other: Standard Therapy

Interventions

Military Field Stimulator DEVICE

The Military Field Stimulator (MFS/Neuro-Stim System), a percutaneous electrical neural field stimulation (PENFS) device evolved from PENS, is currently employed by the United States (US) military and used in the VA (contract number V797D-50453). There is some evidence based on a small trial of 20 postoperative patients that suggests PENS may have greater benefit than acupuncture for acute pain.

Also known as: MFS, Neuro-Stim System, PENFS

PENFS

Standard Therapy OTHER

Standard therapy for fibromyalgia will include physical therapy, medication management through the Anesthesiology Pain Clinic, and referral to a pain psychologist.

Standard Therapy

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia, 30033, United States

Location

Related Publications (2)

• Gebre M, Woodbury A, Napadow V, Krishnamurthy V, Krishnamurthy LC, Sniecinski R, Crosson B. Functional Magnetic Resonance Imaging Evaluation of Auricular Percutaneous Electrical Neural Field Stimulation for Fibromyalgia: Protocol for a Feasibility Study. JMIR Res Protoc. 2018 Feb 6;7(2):e39. doi: 10.2196/resprot.8692.

  PMID: 29410385 BACKGROUND

• Woodbury A, Krishnamurthy V, Gebre M, Napadow V, Bicknese C, Liu M, Lukemire J, Kalangara J, Cui X, Guo Y, Sniecinski R, Crosson B. Feasibility of Auricular Field Stimulation in Fibromyalgia: Evaluation by Functional Magnetic Resonance Imaging, Randomized Trial. Pain Med. 2021 Mar 18;22(3):715-726. doi: 10.1093/pm/pnaa317.

  PMID: 33164085 DERIVED

Related Links

• Peri-Auricular PENFS for Chronic Pain

MeSH Terms

Conditions

Fibromyalgia

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Dr. Anna Woodbury
• Organization: VAORD

anna.woodbury@va.gov

404-321-6111

Study Officials

• Anna Woodbury, MD

  Atlanta VA Medical and Rehab Center, Decatur, GA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Percutaneous electrical neural field stimulator (PENFS) using the military field stimulator, a device that uses small needles inserted in the ear (like auricular acupuncture), which are connected by electrodes to a battery pack that is attached externally using adhesive to the back of the ear. The stimulator is meant to stimulate branches of the cranial nerves via the ear.

Study Record Dates

• First Submitted: December 14, 2016
• First Posted: January 4, 2017
• Study Start: June 1, 2017
• Primary Completion: May 31, 2019
• Study Completion: May 31, 2019
• Last Updated: July 27, 2020
• Results First Posted: July 27, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)