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

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

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

Study Overview

• Status: Completed
• Conditions: Facet Related Low Back Pain
• Intervention / Treatment: Device: Focused Ultrasound Thermal ablation

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H3G 1A4
      • Alan Edwards Pain Management Unit - Montreal General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test Arm; Focused Ultrasound Thermal ablation of the Medial Nerve Branch	Device: Focused Ultrasound Thermal ablation; Focused Ultrasound Thermal ablation of the Medial Nerve Branch

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: FUSMobile Inc.
• Collaborators: Focused Ultrasound Foundation

Publications and helpful links

General Publications

• Perez J, Gofeld M, Leblang S, Hananel A, Aginsky R, Chen J, Aubry JF, Shir Y. Fluoroscopy-Guided High-Intensity Focused Ultrasound Neurotomy of the Lumbar Zygapophyseal Joints: A Clinical Pilot Study. Pain Med. 2022 Jan 3;23(1):67-75. doi: 10.1093/pm/pnab275.

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2017
• Primary Completion (Actual): February 28, 2019
• Study Completion (Actual): February 19, 2020

Study Registration Dates

• First Submitted: October 18, 2017
• First Submitted That Met QC Criteria: October 22, 2017
• First Posted (Actual): October 25, 2017

Study Record Updates

• Last Update Posted (Actual): January 25, 2021
• Last Update Submitted That Met QC Criteria: January 22, 2021
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: LBP-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No