Safety and Initial Feasibility of Using the Neurolyser for Facet Related Low Back Pain

Study Overview
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Brief Summary
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Single arm pilot study to evaluate the safety and initial feasibility of the Neurolyser XR, a new portable high intensity focused ultrasound device, for noninvasive thermal ablation of medial nerve branches of painful lumbar facet joint/s

Detailed Description
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Study design: Prospective, single arm Timeline: six month enrollment period and 12 months follow-up period. Sites: The study will be conducted at McGill University. Study population: Ten adult patients diagnosed with facet related low back pain. Primary study objective: Safety and efficacy of the Neurolyser XR for the treatment of facet related low back pain. Safety would be evaluated by the incidence and severity of treatment related adverse events Efficacy would be evaluated by the changes in average pain score and Rolland Morris Disability Questionnaire between baseline and 6 months.

Official Title
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Safety and Initial Feasibility of Using the Neurolyser XR Device for the Treatment of Facet Related Low Back Pain

Conditions
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Facet Related Low Back Pain

Intervention / Treatment
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* Device: Focused Ultrasound Thermal ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult male and females, legally able and willing to participate in the study and come for follow-up visits Able and willing to fill the study forms and to communicate with investigator Patient with uni or bilateral lumbar facetogenic pain of > 6 months duration Patients presenting with a) a positive (>70% pain relief) to a previous L1 to L5 lumbar medial branch block and / or b) with a positive (>70% pain relief) to a previous lumbar facet thermal RF denervation within the last 6 months) Average pain score of 4 or higher in the last month, (on a scale of 0 to 10) Exclusion Criteria: Pregnant or breastfeeding patient Patients younger than 18 or older than 80 years Patients presenting with neurological deficits (including lumbosacral radiculopathy but not radicular pain). History of spine surgery Presence of metal hardware at the lumbosacral spine Lumbar spine pathology that may increase procedural risk and / or influence symptoms and / or generate unrelated adverse event, (per the discretion of the study PI) Patients unable to understand and complete the research questionnaires in English or French Any severe medical condition preventing the patient from safely and effectively being treated in the study or reporting study outcome. Patient with extensive scarring in the skin and tissue overlying the treatment area. Patients enrolled in or planned to be enrolled in another clinical trial during the duration of this research project

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Single arm, non-randomized
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test Arm<br>Focused Ultrasound Thermal ablation of the Medial Nerve Branch | Device: Focused Ultrasound Thermal ablation<br>* Focused Ultrasound Thermal ablation of the Medial Nerve Branch<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NRS | Reduction in average pain score as measured by a numeric rating scale from 0 (no pain) to 10, worst possible pain | Base line, 2 days 1, 2 & 4 weeks, 3, 6 & 12 months after procedure | 
| RMD | Reduction in Rolland Morris Disability Questionnaire score | Base line, 1 & 4 weeks, 3, 6 & 12 months after procedure | 
| Saftey | Safety will be measured by the incidence and severity of treatment related adverse events | Base line, Procedure day, 2 days 1, 2 & 4 weeks, 3, 6 & 12 months after procedure |