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Auricular Vagus Nerve Stimulation for Chronic Pain | Clinical Trials | Clareo Health

COMPLETEDNA

Auricular Vagus Nerve Stimulation for Chronic Pain

Transcutaneous Auricular Vagus Nerve Stimulation for Chronic Pain

NCT03959111•Massachusetts General Hospital

Summary

This proposal aims to investigate the treatment effect and underlying mechanism of transcutaneous acupuncture stimulation on chronic low back pain. We believe that this study, if successful, will provide new treatment options for chronic low back pain, reduce the use of opioid analgesics in chronic pain management, and enhance our understanding of the underlying mechanism of nerve stimulation treatment, as well as the pathophysiology and development of chronic pain.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Volunteers 18-65 years of age.
•Meet the Classification Criteria of chronic LBP (having low back pain for more than 6 months), as determined by a referring physician.
•Received stable treatment or no treatment in the past month.
•At least a 10th grade English-reading level. English can be a second language provided that the patients feel they understand all the questions used in the assessment measures.

Exclusion Criteria

•Specific causes of back pain (e.g., epidural abscess, compression fracture, spondyloarthropathy, malignancy, cauda equina syndrome) or radicular pain, radiculopathy, or spinal canal stenosis. Complicated back problems (e.g., prior back surgery, medico-legal issues).
•Presence of headache/migraine, as well as widespread body pain such as fibromyalgia.
•The intent to undergo surgery during participation in the study.
•History of cardiac, respiratory, or nervous system disease that, in the investigator's judgment, precludes participation in the study because of a heightened potential for adverse outcomes (e.g., asthma or claustrophobia).
•Presence of any contraindications to MRI scanning (e.g., cardiac pacemaker, metal implants, fear of enclosed spaces, pregnancy, cannot lie still in fMRI scanner).
•Conditions that might confound longitudinal effects or interpretation of results (e.g. severe fibromyalgia, rheumatoid arthritis).
•Pregnant or lactating.
•Conditions making study participation difficult (e.g., paralysis, psychoses, or other severe psychological problems as per the judgment of a study investigator during Session 1).
•Active substance abuse disorders within the last 24 months (based on subject self-report).
•Use of prescription steroids for pain during the past six months.
+2 more criteria

Locations (1)

Massachusetts General Hospital

Charlestown, Massachusetts, United States

Key Dates

Start Date

October 17, 2019

Primary Completion Date

April 30, 2024

Completion Date

April 30, 2024

Last Updated

March 11, 2026

Enrollment

ACTUAL participants

Conditions

Low Back Pain

Interventions

Stimulation at Location 1

OTHER

Stimulation at Location 2

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 11, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Auricular Vagus Nerve Stimulation for Chronic Pain

Inclusion Criteria

Exclusion Criteria

Examination of Nociscan Impact on Discogenic Low Back Pain Surgical Outcomes

Study of the Contribution of Osteopathic Treatment to Classic Medical Management in Patients With Chronic Low Back Pain

Time to BBVNA Relief

The Effects of EXOPULSE Mollii Suit on Low Back Pain

The Effect of ESWT Added to Conservative Treatment on Pain, Disability, and Ultrasonographic Outcomes in Chronic Low Back Pain

Pilates Exercises on Nonspecific Low Back Pain in Postnatal Women