Ear nerve stimulation at home for knee osteoarthritis pain in Veterans

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for Veterans with knee osteoarthritis and moderate to severe knee pain. It compares home ear nerve stimulation (taVNS) at two doses with a steroid injection in the knee.

Age

45 Years to 75 Years

Sex

All sexes can join.

Disease stage

Knee osteoarthritis diagnosed by ACR criteria and confirmed on X-ray or other imaging. Moderate to severe knee pain, a score of 4 or more on the DVPRS pain scale. Must be able to walk and attend all visits.

Earlier treatment

Must be willing to stop current knee OA pain medicines during the trial, except allowed rescue medicine such as acetaminophen/paracetamol. No corticosteroid or hyaluronic acid injection in the study knee within 12 weeks, and no systemic corticosteroids within 30 days. No knee arthroplasty or arthroscopy on the study knee within 6 months.

Main reasons for not taking part

• Inflammatory joint disease such as rheumatoid arthritis, other causes of arthritis, or major knee injury within 3 months.
• Metal implants above the neck, active ear infection, recent ear injury, or long-term ear or face pain.
• Past vagus nerve surgery or ongoing vagus nerve stimulation for another condition.
• Severe uncontrolled illness, such as liver or kidney disease, active cancer, high blood pressure, heart disease or diabetes with nerve damage.
• Another interventional trial within the past 2 months, or a severe unstable mental health disorder.

The registry criteria, word for word

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

• Are you between 45 and 75 years old?YesNo

What the trial wants to find out

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 participants. No specimens or data will be banked for future research use. Informed consent will be obtained from participants in person via signatures on written informed consent forms.

The 3 groups in the trial

• Standard-of-care CSIOther group

  Participants allotted to this group will receive gold-standard corticosteroid injection (CSI), a standard-of-care option for treating and managing knee osteoarthritis (KOA) pain.

  Treatment: Methylprednisolone acetate

• Low-dose taVNSExisting treatment, for comparison

  Transcutaneous auricular vagus nerve stimulation (taVNS) is a self-administered, home-based, non-invasive therapy with minimal risk of side effects. Mechanistically, taVNS targets auricular vagal afferents and requires afferent signaling to the nucleus tractus solitarius (NTS) to activate downstream efferent pathways in the central nervous system, including higher brain regions involved in pain processing (Fig 1), exerting anti-nociceptive effects. Participants allocated to this group will receive low-dose taVNS (n=15; 30-60 min/day, 3 days/week) for 12 weeks.

  Treatment: taVNS

• High-dose taVNSExisting treatment, for comparison

  Transcutaneous auricular vagus nerve stimulation (taVNS) is a self-administered, home-based, non-invasive therapy with minimal risk of side effects. Mechanistically, taVNS targets auricular vagal afferents and requires afferent signaling to the nucleus tractus solitarius (NTS) to activate downstream efferent pathways in the central nervous system, including higher brain regions involved in pain processing (Fig 1), exerting anti-nociceptive effects. Participants allocated to this group will receive high-dose taVNS (n=15; 1-2 hours/day, 7 days/week) for 12 weeks.

  Treatment: taVNS