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

NCT03321344 | Completed

• 1 other identifier: LBP-001
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Conditions

Facet Related Low Back Pain

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Test Arm

EXPERIMENTAL

Focused Ultrasound Thermal ablation of the Medial Nerve Branch

Device: Focused Ultrasound Thermal ablation

Interventions

Focused Ultrasound Thermal ablation DEVICE

Focused Ultrasound Thermal ablation of the Medial Nerve Branch

Test Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• FUSMobile Inc.: lead
• Focused Ultrasound Foundation: collaborator

Study Sites (1)

Alan Edwards Pain Management Unit - Montreal General Hospital

Montreal, Quebec, H3G 1A4, Canada

Location

Related Publications (1)

• 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.

  PMID: 34534337 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single arm, non-randomized

Study Record Dates

• First Submitted: October 18, 2017
• First Posted: October 25, 2017
• Study Start: December 5, 2017
• Primary Completion: February 28, 2019
• Study Completion: February 19, 2020
• Last Updated: January 25, 2021

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)