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 study involves the use of sound waves to block pain signals caused by osteoarthritis of the knee. The sound waves are tightly focused on a specific area of the nerve. The sound waves cause a break in the nerve which carries pain signals. Sound waves transmit through the skin so there is no need for needles. The procedure takes approximately one hour. The device has been approved in Health Canada and Europe for the treatment of lower back pain. This study is to evaluate the use of the same device for people in Canada who have knee pain related to osteoarthritis.

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.
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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+