Shock without drugs: nerve zap eases back pain?
NCT ID NCT03959111
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested a device that stimulates a nerve in the ear to treat chronic low back pain. 70 adults used the device daily for four weeks. Researchers measured changes in pain intensity and physical disability to see if this drug-free approach could help.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- transcutaneous auricular vagus nerve stimulation device
- What this could lead to
- If it works, this could offer a drug-free option to ease chronic low back pain and reduce reliance on painkillers like opioids.
- What could go wrong
- This was a small, early study with no control group, so results may not be reliable. The device may not work for everyone, and benefits could be due to a placebo effect.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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70 people
The number who actually took part.
- Started
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Oct 2019
- Finished
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Apr 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Massachusetts General Hospital
Charlestown, Massachusetts, 02129, United States
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