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Auricular Vagus Nerve Stimulation for Chronic Pain

CompletedNot applicableNCT03959111
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
Transcutaneous Auricular Vagus Nerve Stimulation for Chronic Pain
Conditions
Interventions
  • Other: Stimulation at Location 1
  • Other: Stimulation at Location 2
Sponsor
Massachusetts General Hospital
Start date
2019-10-17
Primary completion
2024-04-30
Sex
All
Age range
from 18 Years to 65 Years
Results posted
Yes, on ClinicalTrials.gov
Countries
United States
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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. * Presence of any other acute or chronic pain disorder. * Any medical conditions, such as peripheral neuropathy, that could affect the results of QST.

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03959111