Ear stimulation vs. steroid shots: a new test for knee pain relief

NCT ID NCT07804199

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This trial is taking on new participants right now.
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The trial has finished. Results may not be published yet.
Stopped early
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Cancelled before anyone took part.

Expanded access (not trials)

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Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
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Not a trial. The treatment could once be requested outside a study, but no longer can.
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First seen Sep 04, 2026 · Last updated Sep 04, 2026

Summary

This pilot study tests whether a home-based device that stimulates the vagus nerve through the ear can reduce pain and inflammation in veterans with knee osteoarthritis. Researchers will compare two different daily doses of this nerve stimulation against a standard steroid injection. Participants will use the device or receive the injection for 12 weeks, with blood and joint fluid samples taken to measure inflammatory markers. The goal is to find the best dose for pain relief and to lay groundwork for future combination treatments.

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 (taVNS), a non-invasive device that stimulates the vagus nerve through the ear, compared with a corticosteroid injection (methylprednisolone acetate).
What this could lead to
If it works, this could offer veterans a drug-free, home-based option for knee osteoarthritis pain and inflammation, and possibly reduce the need for steroid injections.
What could go wrong
This is a small pilot study with 40 participants, so results may not apply broadly. The optimal dose is unknown, and the treatment may not outperform the standard steroid injection.

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

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a US federal agency other than the NIH.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

45 to 75 years

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Clinical diagnosis of knee osteoarthritis according to the American College of Rheumatology (ACR) criteria, confirmed by radiologic evidence of the same. * Moderate to severe knee pain, as assessed by the Defense Veterans Pain Rating Scale (DVPRS), a validated pain scale (score ≥4) * Willingness to discontinue current knee osteoarthritis (OA) pain medications (except permitted rescue medication such as acetaminophen/paracetamol) during the trial * Ability to provide informed consent and comply with all study procedures * Ambulatory and able to attend all study visits Exclusion Criteria: * History or evidence of inflammatory joint disease (e.g., rheumatoid arthritis, spondyloarthropathy), secondary or metabolic causes of arthritis, or significant trauma to the knee within 3 months prior to screening * Recent or planned major knee surgery on the index knee (arthroplasty or arthroscopy within 6 months) * Received intra-articular corticosteroid or hyaluronic acid injections in the index knee within 12 weeks prior to screening, or systemic corticosteroids within 30 days * Contraindications to transcutaneous auricular vagus nerve stimulation (taVNS), such as: oMetal implants above the neck oActive ear infection, recent ear trauma, or chronic ear/facial pain oPrior vagus nerve surgery (including vagotomy) or ongoing VNS therapy for another condition * Severe comorbidities (e.g., uncontrolled liver/kidney disease, active malignancy, uncontrolled hypertension or cardiovascular disease, uncontrolled diabetes with neuropathy) * Participation in another interventional clinical trial within the past 2 months * Inability to provide informed consent or comply with protocol requirements (e.g., significant cognitive impairment) * Any unstable or severe psychiatric disorder that, in the investigator's opinion, would compromise safety or compliance

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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.

How to take part

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  1. The places running it

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  2. The official record

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  3. A doctor treating you

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Contacts and locations

Locations

  • Atlanta VA Medical and Rehab Center, Decatur, GA

    Decatur, Georgia, 30033-4004, United States

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