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

Primary Purpose

Facet Related Low Back Pain

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Focused Ultrasound Thermal ablation

About this trial

This is an interventional treatment trial for Facet Related Low Back Pain

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Alan Edwards Pain Management Unit - Montreal General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Test Arm

Arm Description

Focused Ultrasound Thermal ablation of the Medial Nerve Branch

Outcomes

Primary Outcome Measures

NRS

Reduction in average pain score as measured by a numeric rating scale from 0 (no pain) to 10, worst possible pain

RMD

Reduction in Rolland Morris Disability Questionnaire score

Saftey

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

Secondary Outcome Measures

Full Information

NCT ID

NCT03321344

First Posted

October 18, 2017

Last Updated

January 22, 2021

Sponsor

FUSMobile Inc.

Collaborators

Focused Ultrasound Foundation

1. Study Identification

Unique Protocol Identification Number

NCT03321344

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Completed

Study Start Date

December 5, 2017 (Actual)

Primary Completion Date

February 28, 2019 (Actual)

Study Completion Date

February 19, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

FUSMobile Inc.

Collaborators

Focused Ultrasound Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Facet Related Low Back Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Single arm, non-randomized

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Test Arm

Arm Type

Experimental

Arm Description

Focused Ultrasound Thermal ablation of the Medial Nerve Branch

Intervention Type

Device

Intervention Name(s)

Focused Ultrasound Thermal ablation

Intervention Description

Focused Ultrasound Thermal ablation of the Medial Nerve Branch

Primary Outcome Measure Information:

Title

NRS

Description

Reduction in average pain score as measured by a numeric rating scale from 0 (no pain) to 10, worst possible pain

Time Frame

Base line, 2 days 1, 2 & 4 weeks, 3, 6 & 12 months after procedure

Title

RMD

Description

Reduction in Rolland Morris Disability Questionnaire score

Time Frame

Base line, 1 & 4 weeks, 3, 6 & 12 months after procedure

Title

Saftey

Description

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

Time Frame

Base line, Procedure day, 2 days 1, 2 & 4 weeks, 3, 6 & 12 months after procedure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Alan Edwards Pain Management Unit - Montreal General Hospital

City

Montréal

State/Province

Quebec

ZIP/Postal Code

H3G 1A4

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

34534337

Citation

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.

Results Reference

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

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