Focused ultrasound nerve treatment for medial knee osteoarthritis pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Unika Medical Centre
  North York, Ontario, Canada Recruiting

Study contacts

• Study coordinator: Melissa Diep Research Coordinator
• Email: assistant@unikamed.com
• Phone: 647-740-0160 Canada

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.