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Neurolysis for the Treatment of Medial Chronic Knee Pain Due to Osteoarthritis

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Trial details

Who runs it
FUSMobile Inc.
Trial code
NCT07178951
Record updated
9 November 2026
Original description
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.Read full original descriptionShow less

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

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.

Inclusion: Moderate to severe, predominantly medial chronic knee pain; Age adult >18 years old; WOMAC Score of 30 or higher; NRS>6 with ambulation; Radiological confirmation of knee osteoarthritis (Kellgren-Lawrence Scale: 2-4); Participants in whom the measured skin to bone depth is 2-6 cm using imaging ultrasound and ultrasound gel pad in the upper medial and lower medial joint capsule targets.

Exclusion: Individuals after any surgery associated with altered integrity of bone structure; Individuals with concomitant mental health disorders, excluding compensated mood disorders; Individuals who are scheduled for any interventional/surgical procedure within 3 months from the screening date, excluding trivial surgeries (e.g., cataract, skin tumors); Individuals presenting with any severe medical condition preventing the participant from safely and effectively being treated in the study or reporting study outcomes, per PI decision; Symptomatic multifocal nociplastic chronic pain (e.g., fibromyalgia, generalized osteoarthritis) or any other chronic pain condition that could influence symptoms; Individuals meeting any of the following criteria are not eligible for participation in this study:; Individuals with severe pain in the second knee; Individuals unable to understand and complete the research questionnaires in the official language; Individuals with extensive scarring of the skin and tissue overlying the treatment area; Individuals enrolled in or planned to be enrolled in another clinical trial during the duration of this research project; Individuals with active inflammatory (e.g., rheumatoid) arthritis; Individuals with altered perception and processing of pain: Average NRS > 9, PCS>30, SSS-8 > 11, CSI>40 [46], [47], [48]; Individuals with a first-degree family member already enrolled in this study; Inability to attend follow-up visits and physiotherapy due to travel distance or other restrictions; Participants who have undergone radiofrequency ablation of the genicular nerves in the planned treatment limb within the preceding 6 months.

ClinicalTrials.gov NCT07178951