Knee Osteoarthritis study: Methylprednisolone acetate vs TaVNS
Official title taVNS in Veterans With Knee OA (AVAHCS)
ClinicalTrials.gov ID: NCT07804199
What this study is testing
What is Methylprednisolone acetate?
This is an FDA-approved corticosteroid injection being studied as a comparison treatment for knee osteoarthritis pain. It is designed to reduce inflammation and swelling in the knee joint.
Also referred to as Depo-Medrol, Depo-Medrate, Depo-Medrone.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to find the best settings for a nerve-stimulating device to reduce pain and swelling in the knee. It compares this device to a common steroid injection.
- Who it's for
- The study is looking for veterans who have knee osteoarthritis.
- What's involved
- Participants will receive either a steroid injection or use a small device on their ear to stimulate a nerve. They will also have blood and knee fluid tests at the start, after one month, and after three months.
- Time commitment
- The study lasts 12 weeks and requires visits at the start, after one month, and after three months.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 to 75
You may be able to join if
- Clinical diagnosis of knee osteoarthritis according to the American College of Rheumatology (ACR) criteria, confirmed by radiologic evidence of the...
- 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)...
- Ability to provide informed consent and comply with all study procedures
- Ambulatory and able to attend all study visits
You likely can't join if
- History or evidence of inflammatory joint disease (e.g., rheumatoid arthritis, spondyloarthropathy), secondary or metabolic causes of arthritis, or...
- 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...
- Metal implants above the neck
- Active ear infection, recent ear trauma, or chronic ear/facial pain
- Prior vagus nerve surgery (including vagotomy) or ongoing vagus nerve stimulation (VNS) therapy for another condition
See the full eligibility 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
- 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
- Metal implants above the neck
- Active ear infection, recent ear trauma, or chronic ear/facial pain
- Prior vagus nerve surgery (including vagotomy) or ongoing vagus nerve stimulation (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 treatment 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
The study team makes the final eligibility decision.
Where it is enrolling
- Decatur, Georgia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 45 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Decatur, Georgia, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.