10 Participants Needed

Neurolysis for Knee Arthritis

MD
Overseen ByMelissa Diep Research Coordinator
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: FUSMobile Inc.
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 a new method to manage knee pain from osteoarthritis using sound waves. The treatment, called neurotomy of the medial sensory articular branches, targets specific nerves with sound waves to block pain signals, eliminating the need for needles. Already used for back pain in Canada and Europe, this trial tests its effectiveness for knee pain. Individuals with moderate to severe knee pain from osteoarthritis who experience significant discomfort while walking might be suitable candidates. As an unphased trial, this study provides a unique opportunity to investigate an innovative treatment option for knee pain relief.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this device is safe for treating knee arthritis?

Research has shown that using sound waves to treat knee pain from osteoarthritis appears promising. Studies indicate that targeting the nerves in the knee with sound waves is generally well-tolerated. One study found that this treatment causes fewer side effects than common pain treatments like NSAIDs (non-steroidal anti-inflammatory drugs) and steroid injections.

The device used for this treatment has approval in Canada and Europe for treating lower back pain, suggesting its safety. This treatment avoids needles, directing sound waves at the nerves to block pain signals, which most people find manageable.

In summary, current evidence supports the safety of this treatment for most people, with minimal side effects.12345

Why are researchers excited about this trial?

Unlike traditional treatments for knee arthritis, which often involve medications like NSAIDs or corticosteroid injections to reduce inflammation, the treatment being studied here, thermal ablation with Neurolyser XR, offers a different approach. It targets the sensory nerves in the knee joint directly by using controlled heat to disrupt pain signals. This precise method could provide longer-lasting pain relief without the need for ongoing medication. Researchers are excited about this treatment because it potentially offers a non-pharmacological option that directly addresses the source of pain, potentially reducing side effects associated with long-term drug use.

What evidence suggests that this device is effective for knee arthritis?

Research has shown that sound wave therapy, similar to the approach used in this trial, effectively manages pain in other conditions. The device used in this trial already has approval in Canada and Europe for treating lower back pain, indicating its ability to block pain signals in that area. The sound waves aim to stop pain signals from traveling through the nerves in the knee, potentially reducing osteoarthritis pain. Although this approach is new for knee arthritis, its success in treating lower back pain suggests it could also help manage knee pain.

Are You a Good Fit for This Trial?

This trial is for adults over 18 with moderate to severe knee pain, mainly on the inside of the knee due to osteoarthritis. They should have a WOMAC score of 30+ and an NRS score above 6 when walking, plus X-ray evidence of arthritis (Kellgren-Lawrence Scale: 2-4). Their skin-to-bone depth at certain knee points must be between 2-6 cm.

Inclusion Criteria

I have moderate to severe knee pain mostly on the inside.
I am over 18 years old.
My pain and joint function score is 30 or more.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a procedure using the Neurolyser XR device to ablate sensory nerves in the knee joint

1 hour
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including MRI and pain assessments

6 months
Multiple visits at 2 days, 7 days, 1 month, 3 months, and 6 months (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Neurotomy of the medial sensory articular branches

Trial Overview

The study tests a sound wave device that blocks nerve pain signals in the knee caused by osteoarthritis. The non-invasive procedure takes about an hour and has been approved elsewhere for back pain. This Canadian study aims to evaluate its effectiveness specifically for knee pain from osteoarthritis.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Thermal ablation with Neurolyser XRExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

FUSMobile Inc.

Lead Sponsor

Trials
7
Recruited
170+

Citations

Neurolysis for the Treatment of Medial Chronic Knee Pain ...

Safety and Feasibility of the Neurolyser XR Device for the Treatment of Predominantly Medial Chronic Knee Pain Due to Osteoarthritis.

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40054598/

Efficacy and safety of minimally invasive interventions ...

Efficacy and safety of minimally invasive interventions targeting the genicular nerves for knee osteoarthritis: A meta-analysis. Osteoarthritis ...

Minimally Invasive Therapies for Knee Osteoarthritis

This article explores the mechanisms of action, efficacy, and complications associated with intra-articular steroid, hyaluronic acid, and platelet-rich plasma ...

Motor-Sparing Neural Ablation with Modified Techniques ...

Radiofrequency (RF) neurotomy is a therapeutic alternative for chronic pain. We investigated whether RF neurotomy applied to articular nerve ...

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/32701684/

Thermal Nerve Radiofrequency Ablation for the ...

These results demonstrate geniculate nerve thermal RFA to be a superior nonsurgical treatment of knee OA compared with NSAIDs and IA corticosteroid injections.