Testing Neurotomy of the medial sensory for osteoarthritis (OA) of the knee
Official title: Neurolysis for the Treatment of Medial Chronic Knee Pain Due to Osteoarthritis
Safety and Feasibility of the Neurolyser XR Device for the Treatment of Predominantly Medial Chronic Knee Pain Due to Osteoarthritis
Interventions
Neurotomy of the medial sensory articular branches
Non-invasive thermal ablation of the medial sensory articular branches of the knee joint
Canadian Sites (1)
Unika Medical Centre
North York, Ontario, Canada
Eligibility Criteria
See who this study is looking for21 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Radiological confirmation of knee osteoarthritis (Kellgren-Lawrence Scale: 2-4)
- +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.
- +Moderate to severe, predominantly medial chronic knee pain
- +Age adult \>18 years old
- +WOMAC Score of 30 or higher
- +NRS\>6 with ambulation
Exclusion
- −Individuals meeting any of the following criteria are not eligible for participation in this study:
- −Individuals with severe pain in the second knee
- −Individuals unable to understand and complete the research questionnaires in the official language
- −Individuals presenting with any severe medical condition preventing the participant from safely and effectively being treated in the study or reporting study outcomes, per PIPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → decision
- −Individuals with extensive scarring of the skin and tissue overlying the treatment area
- −Individuals enrolledEnrolmentThe number of participants a study plans to include, or has included.Read more → in or planned to be enrolled in another clinical trialInterventional studyA study where participants are given something to see what happens.Read more → during the duration of this research project
- −Individuals with active inflammatory (e.g., rheumatoid) arthritis
- −Individuals with concomitant mental health disorders, excluding compensated mood disorders
- −Individuals with altered perception and processing of pain: Average NRS \> 9, PCS\>30, SSS-8 \> 11, CSI\>40 \[46\], \[47\], \[48\]
- −Individuals with a first-degree family member already enrolled in this study
- −Individuals who are scheduled for any interventional/surgical procedure within 3 months from the screeningScreeningThe checks done before joining, to see whether a study fits.Read more → date, excluding trivial surgeries (e.g., cataract, skin tumors)
- −Inability to attend follow-upFollow-upContinued check-ins after the treatment part is finished.Read more → visits and physiotherapy due to travel distance or other restrictions
- −Symptomatic multifocal nociplastic chronic pain (e.g., fibromyalgia, generalized osteoarthritis) or any other chronic pain condition that could influence symptoms.
- −Participants who have undergone radiofrequency ablation of the genicular nerves in the planned treatment limb within the preceding 6 months.
- −Individuals after any surgery associated with altered integrity of bone structure
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
What is being given or done in this study: Neurotomy of the medial sensory articular branches.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
There is only one group in this study, so there is no assignment to different treatments.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
There is one group in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 10 people.
The study is currently expected to finish around December 2026.
The main measurement is taken over: BaselineBaselineYour starting measurements, taken before treatment begins.Read more → score will be compared to post procedure intervals at 2 days, 7 days, 1 month, 3 months, and 6 months.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
A positive clinical outcome will be measured by a 2-point reduction in the Numerical Rating Score (NRS) — measured over BaselineBaselineYour starting measurements, taken before treatment begins.Read more → 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 eventsAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → — measured over Adverse events will be evaluated at baseline and post procedure - 2 days, 7 days, 1 month, 3 months, and 6 months.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07178951 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Neurotomy of the medial sensory articular branchesDevice
Non-invasive thermal ablation of the medial sensory articular branches of the knee joint
From the trial registry — its own words, unedited.
What a device is here: A physical instrument, implant, app or piece of equipment being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
There is only one group in this study, so there is no assignment to different treatments.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: BaselineBaselineYour starting measurements, taken before treatment begins.Read more → score will be compared to post procedure intervals at 2 days, 7 days, 1 month, 3 months, and 6 months..
The study as a whole is currently expected to finish around 2026-12.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 10 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: North York, Ontario, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
Think this trial might be right for you?
Complete a quick intake form and we will match you with this and other relevant trials based on your medical profile.
See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.