Focused ultrasound nerve treatment for medial knee osteoarthritis pain

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

This study will try focused ultrasound delivered through the skin to disrupt a small medial knee nerve and reduce chronic osteoarthritis pain in adults with moderate-to-severe medial knee pain.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: FUSMobile Inc. (Industry-sponsored)
• Locations: 1 site (North York, Ontario)
• Trial ID: NCT07178951 on ClinicalTrials.gov

What this trial studies

This interventional study uses a focused ultrasound device to create targeted neurolysis of the medial sensory articular branches that carry knee pain signals, without needles or incisions. The procedure is done under imaging guidance (standard X-ray) and takes about one hour, with patients typically taking their usual pain medications beforehand. Participants will have baseline and follow-up onsite visits including knee physical exams, pressure algometry, pain ratings, medication histories, and quality-of-life questionnaires. The protocol plans to treat ten participants at a single Canadian site to characterize safety and initial pain response.

Who should consider this trial

Good fit: Adults (≥18) with radiographic knee osteoarthritis (Kellgren-Lawrence grade 2–4), predominantly medial chronic knee pain with WOMAC ≥30 and NRS >6 with ambulation, and a measured skin-to-bone depth of 2–6 cm at the medial joint targets are ideal candidates.

Not a fit: Patients who have altered bone integrity from prior surgery, severe pain in the opposite knee, a skin-to-bone depth outside 2–6 cm, inability to complete study questionnaires in the site language, or other serious medical conditions are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the procedure could provide meaningful pain relief for medial knee osteoarthritis without needles or surgery.

How similar studies have performed: The same device has regulatory approvals in Health Canada and Europe for lower back pain and prior work supports focused ultrasound neurolysis in spine-related pain, but its use for knee osteoarthritis is novel and not yet proven.

Eligibility criteria

Inclusion Criteria:

1. Moderate to severe, predominantly medial chronic knee pain
2. Age adult \>18 years old
3. WOMAC Score of 30 or higher
4. NRS\>6 with ambulation
5. Radiological confirmation of knee osteoarthritis (Kellgren-Lawrence Scale: 2-4)
6. 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:

1. Individuals meeting any of the following criteria are not eligible for participation in this study:
2. Individuals after any surgery associated with altered integrity of bone structure
3. Individuals with severe pain in the second knee
4. Individuals unable to understand and complete the research questionnaires in the official language
5. 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
6. Individuals with extensive scarring of the skin and tissue overlying the treatment area
7. Individuals enrolled in or planned to be enrolled in another clinical trial during the duration of this research project
8. Individuals with active inflammatory (e.g., rheumatoid) arthritis
9. Individuals with concomitant mental health disorders, excluding compensated mood disorders
10. Individuals with altered perception and processing of pain: Average NRS \> 9, PCS\>30, SSS-8 \> 11, CSI\>40 \[46\], \[47\], \[48\]
11. Individuals with a first-degree family member already enrolled in this study
12. Individuals who are scheduled for any interventional/surgical procedure within 3 months from the screening date, excluding trivial surgeries (e.g., cataract, skin tumors)
13. Inability to attend follow-up visits and physiotherapy due to travel distance or other restrictions
14. Symptomatic multifocal nociplastic chronic pain (e.g., fibromyalgia, generalized osteoarthritis) or any other chronic pain condition that could influence symptoms.
15. Participants who have undergone radiofrequency ablation of the genicular nerves in the planned treatment limb within the preceding 6 months.

Where this trial is running

North York, Ontario

• Unika Medical Centre — North York, Ontario, Canada (Recruiting)

Study contacts

• Study coordinator: Melissa Diep Research Coordinator

Conditions Osteoarthritis of the Knee; Knee Pain Arthritis; Chronic Knee Pain; osteoarthritis; knee pain; focused ultrasound; nerve ablation