Neurolysis for the Treatment of Medial Chronic Knee Pain Due to Osteoarthritis
Recruiting · NCT07178951 · Interventional (participants receive a specific treatment) · Lead sponsor: FUSMobile Inc.
View the official record on ClinicalTrials.gov →Interventions studied
Neurotomy of the medial sensory articular branches
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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.
Where it is running
1 location listed.
- Unika Medical Centre - North York, Ontario, Canada