taVNS for Osteoarthritis

(taVNS Trial)

AW
AM
Overseen ByAnna M Ree, BA
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how transcutaneous auricular vagus nerve stimulation (taVNS) can help manage pain and inflammation in veterans with knee osteoarthritis. It compares two different doses of taVNS with a standard corticosteroid injection (methylprednisolone acetate) to determine which best relieves knee pain. The goal is to identify an effective treatment plan that might complement future therapies. Veterans with knee osteoarthritis, who experience moderate to severe knee pain and can discontinue their current pain medications, might be suitable candidates for this trial. As an unphased trial, it offers veterans the opportunity to contribute to innovative research that could lead to new pain management solutions.

What prior data suggests that taVNS is safe for Veterans with osteoarthritis?

Research has shown that transcutaneous auricular vagus nerve stimulation (taVNS) is generally safe and well-tolerated. In studies, participants using taVNS for knee osteoarthritis (OA) reported only mild side effects, typically minor and occurring where the device contacts the skin. Additionally, taVNS may help reduce pain for those with OA.

Overall, evidence suggests that taVNS is a promising and safe option for managing knee OA pain. It works by gently stimulating a nerve in the ear, which can help lessen pain and swelling.12345

Why are researchers excited about this trial?

Unlike the standard of care, which typically involves corticosteroid injections, taVNS (transcutaneous auricular vagus nerve stimulation) offers a unique approach to managing knee osteoarthritis pain. Researchers are excited about taVNS because it is a non-invasive, home-based therapy with minimal risk of side effects, making it more accessible and convenient for patients. This treatment works by targeting auricular vagal afferents to activate pathways in the central nervous system, including areas involved in pain processing, potentially reducing pain through anti-nociceptive effects. The ability to self-administer taVNS at home could significantly enhance patient comfort and compliance compared to more invasive options.

What evidence suggests that this trial's treatments could be effective for osteoarthritis?

This trial will compare different treatments for knee osteoarthritis. One treatment arm involves transcutaneous auricular vagus nerve stimulation (taVNS), which research has shown can reduce knee pain in people with osteoarthritis. Studies found that taVNS lowered knee pain scores by about 1.27 points immediately after treatment and by about 1.87 points 15 minutes later. These findings suggest that taVNS might be a good option for pain relief. Additionally, taVNS is non-invasive and appears safe, with no serious side effects reported. While early results are promising, more research is needed to confirm its long-term benefits. Another arm of this trial will involve the standard-of-care corticosteroid injection (CSI) for managing knee osteoarthritis pain.12367

Who Is on the Research Team?

MA

Mercy A Udoji, MD

Principal Investigator

Atlanta VA Medical and Rehab Center, Decatur, GA

AW

Anna Woodbury, MD

Principal Investigator

Atlanta VA Medical and Rehab Center, Decatur, GA

Are You a Good Fit for This Trial?

This trial is for Veterans with knee osteoarthritis who are able to participate in a 12-week study at the Atlanta VA. Participants must be willing to attend assessment visits and follow treatment instructions.

Inclusion Criteria

Ability to provide informed consent and comply with all study procedures
I have knee osteoarthritis confirmed by X-ray or similar imaging.
I have moderate to severe knee pain with a pain score of 4 or higher.
See 2 more

Exclusion Criteria

Participation in another interventional clinical trial within the past 2 months
Any unstable or severe psychiatric disorder that would compromise safety or compliance in the investigator's opinion
I have had joint disease or a serious knee injury in the past 3 months.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either corticosteroid injection (CSI) or taVNS (high-dose or low-dose) for 12 weeks

12 weeks
3 visits (in-person) at baseline, 4 weeks, and 12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months
1 visit (in-person) at 6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Methylprednisolone acetate
  • taVNS

Trial Overview

The study compares two treatments for knee osteoarthritis pain: transcutaneous auricular vagus nerve stimulation (taVNS) given in either high or low doses, and corticosteroid injection (methylprednisolone acetate). Participants are randomly assigned to one of these groups.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Active Control

Group I: Standard-of-care CSIExperimental Treatment1 Intervention
Group II: Low-dose taVNSActive Control1 Intervention
Group III: High-dose taVNSActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials
1,691
Recruited
3,759,000+

Citations

Safety and preliminary efficacy of transcutaneous auricular ...

Our preliminary data demonstrated that tVNS may be a safe pain-relieving treatment for people with knee OA. Our findings suggest that ...

Transcutaneous Auricular Vagus Nerve Stimulation May ...

“Our preliminary data demonstrated that tVNS may be a safe pain-relieving treatment for people with knee OA,” the authors write. “Our findings ...

Transcutaneous auricular vagus nerve stimulation (taVNS ...

Researchers observed an average pain reduction of 1.27 points immediately after treatment and 1.87 points after 15 minutes, with over one-third ...

Feasibility and Efficacy of Transcutaneous Vagus Nerve ...

Compared to baseline, knee pain was reduced by 1.27 (95% CI, -1.74, -0.80, p<0.001) immediately after and by 1.87 (-2.33, -1.40, p<0.001) 15 minutes after tVNS; ...

Transcutaneous auricular vagus nerve stimulation of ...

At week 12, VAS hand pain had reduced by a median of 16 mm in the taVNS group compared with a median of 6 mm reduction in the sham group. The ...

Transcutaneous auricular vagus nerve stimulation

Safety assessments consistently report that taVNS is generally well-tolerated, with adverse events typically being mild and localized to the stimulation site,

Transcutaneous auricular vagus nerve stimulation versus ...

In participants with erosive hand osteoarthritis, taVNS was safe and well tolerated. Although the primary endpoint was not met, the consistent pain reduction ...