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

Not Applicable

Completed

• Conditions: Facet Related Low Back Pain
• Interventions: Device: Focused Ultrasound Thermal ablation

• Registration Number: NCT03321344
• Lead Sponsor: FUSMobile Inc.

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 branches of painful lumbar facet joint/s

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 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.

Study Timeline

• Study First Submitted: 2017-10-18
• Study First Submitted QC: 2017-10-22
• Study First Posted: 2017-10-25
• Study Start: 2017-12-05
• Primary Completion: 2019-02-28
• Study Completion: 2020-02-19
• Status Verified: 2020-07
• Last Update Submitted: 2021-01-22
• Last Update Posted: 2021-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1. Adult male and females, legally able and willing to participate in the study and come for follow-up visits
2. Able and willing to fill the study forms and to communicate with investigator
3. Patient with uni or bilateral lumbar facetogenic pain of > 6 months duration
4. 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)
5. Average pain score of 4 or higher in the last month, (on a scale of 0 to 10)

Exclusion Criteria

1. Pregnant or breastfeeding patient
2. Patients younger than 18 or older than 80 years
3. Patients presenting with neurological deficits (including lumbosacral radiculopathy but not radicular pain).
4. History of spine surgery
5. Presence of metal hardware at the lumbosacral spine
6. 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)
7. Patients unable to understand and complete the research questionnaires in English or French
8. Any severe medical condition preventing the patient from safely and effectively being treated in the study or reporting study outcome.
9. Patient with extensive scarring in the skin and tissue overlying the treatment area.
10. Patients enrolled in or planned to be enrolled in another clinical trial during the duration of this research project

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Test Arm	Focused Ultrasound Thermal ablation	Focused Ultrasound Thermal ablation of the Medial Nerve Branch

Primary Outcome Measures

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

Trial Locations

Locations (1)

Alan Edwards Pain Management Unit - Montreal General Hospital; 🇨🇦 Montréal, Quebec, Canada