Sound waves zap knee pain without needles
NCT ID NCT07178951
First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 2 times
Summary
This study tests a device that uses focused sound waves to block pain signals in the knee, offering a needle-free option for people with chronic osteoarthritis pain. Ten adults with moderate to severe knee pain will receive a one-hour treatment and be followed for six months. The goal is to see if the procedure is safe and reduces pain by at least 2 points on a 10-point scale.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 10 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2026
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Unika Medical Centre
RECRUITINGNorth York, Ontario, M3J 0H1, Canada
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