taVNS in Veterans With Knee OA (AVAHCS)

NCT ID
NCT07804199
Registry status
Not yet recruiting
Study type
Interventional
Phase
Not applicable
Sponsor
VA Office of Research and Development
Conditions
Knee Osteoarthritis

Overview

ClinicalTrials.gov lists this study as Not yet recruiting.

Official title: Optimizing Home-Based Auricular Vagus Nerve Stimulation for Pain, Function, and Inflammation in Veterans With Knee Osteoarthritis: A Randomized Pilot Dose-Finding Study (AVAHCS) (F4845-C)

Enrollment: 40 participants (Estimated).

What is being studied

  • Intervention: Fused-Ring Compounds
  • Intervention: Methylprednisolone
  • Drug: Methylprednisolone acetate
  • Intervention: Methylprednisolone Acetate
  • Intervention: Polycyclic Compounds
  • Intervention: Prednisolone
  • Intervention: Pregnadienes
  • Intervention: Pregnadienetriols
  • Intervention: Pregnanes
  • Intervention: Steroids
  • Device: taVNS

Who may be eligible

Ages
45 Years to 75 Years
Sex
All
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following eligibility criteria.

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

Study locations

1 study location is listed.

Site recruitment status is not specified in the registry data for these locations.

Countries: United States

  • Georgia, United States: 1

Sample of listed locations

  • Atlanta VA Medical and Rehab Center, Decatur, GA — Decatur, Georgia, 30033-4004, United States — Site recruitment status not specified in the registry data

Study details

Start date
October 1, 2026
Primary completion date
January 1, 2028
Completion date
January 1, 2028
First posted
September 4, 2026

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT07804199
Registry last updated
September 11, 2026
QualifiedStudies registry data refreshed
October 5, 2026
QualifiedStudies record fetched
October 5, 2026

View NCT07804199 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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