Status:
RECRUITING
Neurolysis for the Treatment of Medial Chronic Knee Pain Due to Osteoarthritis
Lead Sponsor:
FUSMobile Inc.
Conditions:
Osteoarthritis (OA) of the Knee
Knee Pain Arthritis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 brea...
Detailed Description
The research staff will provide a detailed description of the procedure to the study participant live, allowing time for the participant to ask questions. Once the participant agrees to be in the stud...
Eligibility Criteria
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 meeting any of the following criteria are not eligible for participation in this study:
- Individuals after any surgery associated with altered integrity of bone structure
- Individuals with severe pain in the second knee
- Individuals unable to understand and complete the research questionnaires in the official language
- 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
- 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 concomitant mental health disorders, excluding compensated mood disorders
- 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
- Individuals who are scheduled for any interventional/surgical procedure within 3 months from the screening date, excluding trivial surgeries (e.g., cataract, skin tumors)
- Inability to attend follow-up visits and physiotherapy due to travel distance or other restrictions
- Symptomatic multifocal nociplastic chronic pain (e.g., fibromyalgia, generalized osteoarthritis) or any other chronic pain condition that could influence symptoms.
- Participants who have undergone radiofrequency ablation of the genicular nerves in the planned treatment limb within the preceding 6 months.
Key Trial Info
Start Date :
January 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT07178951
Start Date
January 1 2026
End Date
December 1 2026
Last Update
January 7 2026
Active Locations (1)
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1
Unika Medical Centre
North York, Ontario, Canada, M3B3S6