Actively Recruiting
Safety and Feasibility of the Neurolyser XR Device for Treatment of Medial Chronic Knee Pain Due to Osteoarthritis
Led by FUSMobile Inc. · Updated on 2026-01-07
10
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new treatment using focused sound waves to block pain signals in people with knee pain caused by osteoarthritis. The study aims to test a device that has been approved for lower back pain but is now being studied for knee pain in Canada. This research focuses on safety and feasibility for people with chronic medial knee pain. The purpose is to see if the device can reduce pain by interrupting nerve signals without surgery or needles. The treatment involves using the Neurolyser XR device to deliver ultrasound waves targeted at the sensory nerves in the knee that cause pain. The procedure lasts about one hour and uses X-ray imaging to guide the device to the correct nerve area without any incisions. Participants will receive this non-invasive thermal ablation treatment once during the study. Some participants may also have an MRI between 5 and 7 days after treatment if possible. During the study, participants will have regular visits for physical exams and pain assessments using numerical rating scales, questionnaires, and medication history reviews. Researchers will measure pain reduction, safety, and changes in sensation at various times up to six months after treatment. They will also track procedure time, radiation exposure, and medication needs during the procedure. The study involves close monitoring to evaluate both pain relief and any treatment-related side effects.
CONDITIONS
Brief Title
Neurolysis for the Treatment of Medial Chronic Knee Pain Due to Osteoarthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Moderate to severe, predominantly medial chronic knee pain
- Age adult >18 years old
- WOMAC Score of 30 or higher
- Numerical Rating Score (NRS) greater than 6 with walking
- Radiological confirmation of knee osteoarthritis (Kellgren-Lawrence Scale: 2-4)
- Skin to bone depth between 2 and 6 cm measured by ultrasound at specific knee areas
You will not qualify if you...
- Previous surgery altering bone structure in the knee
- Severe pain in the other knee
- Inability to understand and complete questionnaires in the official language
- Severe medical conditions preventing safe treatment or outcome reporting
- Extensive scarring over the treatment area
- Participation in another clinical trial during this study
- Active inflammatory arthritis (e.g., rheumatoid arthritis)
- Certain mental health disorders excluding stabilized mood disorders
- Altered pain perception with very high pain scores or symptom severity
- First-degree family member already enrolled in this study
- Planned interventional or surgical procedure within 3 months, excluding minor surgeries
- Inability to attend follow-up visits or physiotherapy due to distance or other reasons
- Multifocal nociplastic chronic pain conditions (e.g., fibromyalgia) or other chronic pain that could affect symptoms
- Radiofrequency ablation of genicular nerves in the treated limb within the last 6 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo a non-invasive procedure using ultrasound waves to ablate the sensory nerves in the knee causing pain. The procedure lasts approximately 1 hour and is performed using X-ray guidance to locate the targeted nerve.
1 visit (in-person)
Duration - 6 months
Participants have several follow-up visits to monitor knee health, pain levels, medication use, and quality of life. Assessments include physical exams, pressure algometry tests, pain rating scales, and questionnaires. For those eligible, an MRI exam of the knee will be performed between days 5 and 7 post-procedure.
Visits at 2 days, 7 days, 1 month, 3 months, and 6 months post-procedure; plus MRI visit between days 5 and 7 when feasible
Trial Site Locations
Total: 1 location
1
Unika Medical Centre
North York, Ontario, Canada, M3B3S6
Actively Recruiting
Research Team
M
Melissa Diep Research Coordinator
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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