Recruiting

Sound Wave Therapy

Sponsor:

FUSMobile Inc.

Code:

NCT07178951

Conditions

Osteoarthritis (OA) of the Knee

Knee Pain Arthritis

Chronic Knee Pain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Neurotomy of the medial sensory articular branches

Study Details

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 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.

Conditions

Osteoarthritis (OA) of the Knee

Knee Pain Arthritis

Chronic Knee Pain

Study ID

NCT07178951

Start date

Sep 9, 2026

Status verified date

Sep, 2025

Completion date

Mar 30, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Thermal ablation with Neurolyser XR

Ablation of sensory nerves in the knee joint

Interventions

Neurotomy of the medial sensory articular branches

Non-invasive thermal ablation of the medial sensory articular branches of the knee joint

Primary outcome measure

  • A positive clinical outcome will be measured by a 2-point reduction in the Numerical Rating Score (NRS) [ Time Frame: Baseline score will be compared to post procedure intervals at 2 days, 7 days, 1 month, 3 months, and 6 months. ]
  • Safety will be measured by the incidence and severity of treatment-related adverse events. [ Time Frame: Adverse events will be evaluated at baseline and post procedure - 2 days, 7 days, 1 month, 3 months, and 6 months. ]

Central Contacts and Locations

Central contacts

Melissa Diep Research Coordinator

647-740-0160 Canadaassistant@unikamed.com

Locations

Unika Medical Centre

Recruiting

North York, Ontario, Canada, M3J 0H1

Contacts

Melissa Diep, Research Coordinator

647-740-0160assistant@unikamed.com

Principal Investigator:

Michael Gofeld, MD

More Information

Sponsor

FUSMobile Inc.

Last update posted

Sep 17, 2026

Last verified

Sep, 2025

Keywords

  • osteoarthritis
  • knee pain
  • focused ultrasound
  • nerve ablation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-22. This information was provided to ClinicalTrials.gov by FUSMobile Inc. on 2026-09-17. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.