Health TrialsbyHealthPanel

Neurolysis for the Treatment of Medial Chronic Knee Pain Due to Osteoarthritis

ConditionsOsteoarthritis (OA) of the KneeKnee Pain ArthritisChronic Knee Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFUSMobile Inc.

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Moderate to severe, predominantly medial chronic knee pain

Age adult >18 years old

WOMAC Score of 30 or higher

NRS>6 with ambulation

Disqualifiers

Individuals after any surgery associated with altered integrity of bone structure

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 PI decision

Trial design

Design model

Single group

Treatments tested in this trial

  • Neurotomy of the medial sensory articular branches

    Device

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

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: Thermal ablation with Neurolyser XRExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

A positive clinical outcome will be measured by a 2-point reduction in the Numerical Rating Score (NRS)

The NRS score is a 10 point scale, 0 to 10, with 0 meaning "no pain" and 10 meaning "worst possible pain"; the NRS score will be measured at baseline and all follow-up intervals - 2 days, 7 days, 1 month, 3 months, and 6 months..

Time frame
Baseline score will be compared to post procedure intervals at 2 days, 7 days, 1 month, 3 months, and 6 months.
2

Safety will be measured by the incidence and severity of treatment-related adverse events.

Adverse events will be evaluated throughout the study.

Time frame
Adverse events will be evaluated at baseline and post procedure - 2 days, 7 days, 1 month, 3 months, and 6 months.

Secondary outcomes

1

Lesion size and location

Lesion size and location as shown in MRI images post treatment as available

Time frame
Participants will have an MRI 5-7 days post treatment when feasible and not contraindicated
2

Procedure time (in minutes)

Procedure time will be documented from start to finish

Time frame
The time of the procedure will be documented in minutes.
3

Radiation exposure (in seconds)

The procedure is completed using fluroscopy. The fluroscopy time is calculated by the C-Arm. This number will be documented.

Time frame
The fluoroscopy time will be calculated and documented during the procedure.
4

Periprocedural analgesic/sedative requirement

Analgesic/sedatives used during the procedure will be documented.

Time frame
During the procedure, analgesic/sedative use will be documented.

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Unika Medical CentreRecruitingM3J 0H1, North York, OntarioCanadaCanada

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

FUSMobile Inc.

Lead sponsor

Source ClinicalTrials.gov
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