No phaseRecruiting

taVNS in Veterans With Knee OA (AVAHCS)

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)

Sponsor
VA Office of Research and Development (US federal)
Enrolment
40 planned
Conditions
Knee Osteoarthritis
Interventions
Methylprednisolone acetate; taVNS
Ages
adults, older adults
Registry
NCT07804199

From the registry

The objectives of this study are to identify an optimal transcutaneous auricular vagus nerve stimulation (taVNS) dosing regimen for pain relief and anti-inflammatory effects in Veterans with knee osteoarthritis (OA), compared to corticosteroid injection (CSI), and lay the groundwork for future combinatorial therapies with cell-based approaches. The population for this study is Veterans with osteoarthritis (OA). This single-center, randomized pilot study will enroll participants with knee OA, who will be allocated to CSI (n=10), high-dose taVNS (n=15; 1-2 hours/day, 7 days/week), or low-dose taVNS (n=15; 30-60 min/day, 3 days/week) for 12 weeks. Synovial fluid and blood samples will be collected at baseline, 4, and 12 weeks for biomarker analysis (pro-inflammatory cytokines: TNF-, IL-6, IL-1 ; anti-inflammatory mediators: IL-10, TGF-). The approximate study duration for each individual participant is 12 weeks of treatment with assessment visits at baseline, one month, and three months. Participants will be recruited at the Atlanta VA. The anticipated total enrollment is 40…

Primary outcomes

  • Improvements in Clinical Pain (DVPRS)
  • Concentration of Pro-inflammatory Cytokines (Blood)
  • Concentration of Pro-inflammatory Cytokines (Synovial Fluid)
  • Concentration of Anti-inflammatory Mediators (Blood)
Full record on ClinicalTrials.gov