Status:
COMPLETED
Safety and Initial Feasibility of Using the Neurolyser for Facet Related Low Back Pain
Lead Sponsor:
FUSMobile Inc.
Collaborating Sponsors:
Focused Ultrasound Foundation
Conditions:
Facet Related Low Back Pain
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
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 br...
Detailed Description
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 pati...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 5 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 19 2020
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03321344
Start Date
December 5 2017
End Date
February 19 2020
Last Update
January 25 2021
Active Locations (1)
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1
Alan Edwards Pain Management Unit - Montreal General Hospital
Montreal, Quebec, Canada, H3G 1A4