Randomized Controlled Trial of CES for Fibromyalgia

NCT04115033 | Completed Results FDA Device

• 2 other identifiers: B3227-W1IK2RX003227-01
• Study Type: interventional
• Target: 50
• 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. CES (Cranial Electrical 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

Keywords

Pain; Fibromyalgia; Magnetic Resonance Imaging; Cranial Electrical Stimulation; Myofascial Pain Syndromes; Veterans

Outcome Measures

Primary Outcomes (1)

• Clinical Pain Change

  For subjects with fibromyalgia, clinical pain was assessed in both groups using the Defense Veterans Pain Rating Scale (DVPRS), a validated measurement tool for pain, as well as analgesic consumption. Clinical pain was measured at baseline, 6 weeks following treatment, and 12 weeks following treatment completion in both groups. Mean differences were measured between the baseline score and the 12-week score. The DVPRS is a combination of several different pain scales including the VAS, verbal rating scale, FACES scale, and numerical rating scale. Measurements will be graded on a scale of 0-10 with 0 being "no pain" and 10 being "severe" or "worst pain."

  baseline, 6 weeks into treatment, and 12 weeks post treatment

Secondary Outcomes (5)

• Change in Rs-fcMRI Connectivity Effect Size

  baseline, 6 weeks into treatment, and 12 weeks post treatment (change from baseline to 12 weeks post reported)

• Sit-to-stand

  baseline, 6 weeks into treatment, and 12 weeks post treatment

• Bicep-curl

  baseline, 6 weeks into treatment, and 12 weeks post treatment

• Handgrip Strength

  baseline, 6 weeks into treatment, and 12 weeks post treatment

• PROMIS Change

  baseline visit and 12 weeks post treatment

Study Arms (2)

True CES

EXPERIMENTAL

Veterans with fibromyalgia who meet study criteria and are randomized to the experimental group will receive standard therapy in addition to cranial electrical stimulation (CES), which involves transfer of current from the alpha-stim device using earclip electrodes. The intention of this FDA-approved device is to relieve pain, though data on its effectiveness is still limited. The treatments can be self administered by the participants. The rs-fcMRI evaluation of neural changes and assessment of clinical pain, function, and quality of life will be performed at the beginning and end of the study.

Device: Alpha-stim

Sham CES

SHAM COMPARATOR

Veterans with fibromyalgia who meet study criteria and are randomized to the sham comparator group will receive standard therapy in addition to a CES device that does not deliver active electrical stimulation. The intention of this FDA-approved device is to relieve pain, though data on its effectiveness is still limited. The rs-fcMRI evaluation of neural changes and assessment of clinical pain, function, and quality of life will be performed at the beginning and end of the study.

Device: Alpha-stim

Interventions

Alpha-stim DEVICE

The device for both groups is the Alpha-stim, a FDA-approved device similar to the Military Field Stimulator (MFS/Neuro-Stim System), a cranial electrical stimulation (CES) device.

Also known as: Alpha-stim, CES

Sham CES; True CES

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.
• 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 electrode placement.
• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia, 30033-4004, United States

Location

Related Links

• Case report: Percutaneous electrical neural field stimulation in two cases of sympathetically-mediated pain
• CDC Fibromyalgia Description

MeSH Terms

Conditions

Fibromyalgia; Pain; Myofascial Pain Syndromes

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Anna Woodbury
• Organization: Atlanta VA Healthcare System, Decatur, GA

Anna.Woodbury@va.gov; anna.woodbury@emory.edu

(404) 277-9390

Study Officials

• Anna Woodbury, MD

  Atlanta VA Medical and Rehab Center, Decatur, GA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Cranial electrical stimulation (CES) using a FDA-approved device that uses earclip electrodes to deliver current through the earlobe. The stimulator is meant to stimulate branches of the cranial nerves via the external ear.

Study Record Dates

• First Submitted: October 2, 2019
• First Posted: October 3, 2019
• Study Start: March 2, 2020
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: May 22, 2026
• Results First Posted: February 27, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)