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)