taVNS for knee osteoarthritis in Veterans

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a small, single-center randomized pilot trial enrolling about 40 Veterans with knee OA. Participants are assigned to either corticosteroid injections or 12 weeks of taVNS at high or low dosing, with assessments at baseline, 1 month, and 3 months. The study will measure pain and function outcomes as well as biomarkers of inflammation in blood and synovial fluid to see if taVNS can modulate inflammatory signals differently than CSI. The taVNS device used is designed for home use and has prior safety data in other conditions. The aim is to identify an effective taVNS dosing strategy and to lay groundwork for future combination therapies in the Veteran population.

Why it matters

Who can join: the full rules

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:

  * Metal implants above the neck
  * Active ear infection, recent ear trauma, or chronic ear/facial pain
  * Prior vagus nerve surgery (including vagotomy) or ongoing vagus nerve stimulation (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

Where it's running

• Atlanta VA Medical and Rehab Center, Decatur, GA
  Decatur, Georgia, United States Recruiting

Study contacts

• Principal investigator: Anna Woodbury, MD — Atlanta VA Medical and Rehab Center, Decatur, GA
• Study coordinator: Anna Woodbury, MD
• Email: Anna.Woodbury@va.gov
• Phone: (404) 321-6111

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.