Safety and Initial Feasibility of Using the Neurolyser XR Device for the Treatment of Axial Chronic Low Back Pain

NCT04129034 | Unknown

• 1 other identifier: LBP-002
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 5

Brief Summary

Single arm pilot study to evaluate the safety and initial feasibility of the Neurolyser XR, a high intensity focused ultrasound device, for non-invasive treatment of axial chronic low back pain

Conditions

Facet Syndrome of Lumbar Spine

Keywords

chronic low back pain; zygapophyseal joint syndrome; Facet syndrome

Outcome Measures

Primary Outcomes (2)

• NRS

  Change 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 months after procedure

• Procedure and Device Safety at six months as measured by measured by the incidence and severity of treatment related adverse events

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

  Time Frame: 6 months after procedure

Secondary Outcomes (5)

• Lesion Size

  2 days post procedure

• Oswestry Disability Index (ODI)

  Time Frame: Base line, 1, & 4 weeks, 3 & 6 months after procedure

• Short Form 12 (SF-12)

  Time Frame: Base line, 1, & 4 weeks, 3 & 6 months after procedure

• Patient Global Impression of Change (PGIC)

  Time Frame: Base line, 1, & 4 weeks, 3 & 6 months after procedure

• Procedure and Device Safety as measured by 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 months after procedure

Study Arms (1)

Treatment

EXPERIMENTAL

Thermal ablation of the medial nerve branch using High Intensity Focused Ultrasound

Device: Neurolyser XR

Interventions

Neurolyser XR DEVICE

Non-Invasive Thermal Ablation of the Medial Branch Nerves

Treatment

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult male and females \>55 years of age legally able and willing to participate in the study and come for follow-up visits
• Able and willing to fill the research questionnaires and to communicate with investigator and research team
• Patient with bilateral or unilateral low back pain of \> 6 months duration
• Patients whose back pain is alleviated by recumbency or comfortable sitting position
• Patients presenting with a) a positive (\>70% pain relief) to a previous, single or double, L1 to L5 lumbar medial branch block (within the last 12 months) and / or b) with a positive (\>70% pain relief lasting more than 6 months) to a previous lumbar facet thermal radiofrequency denervation.
• Average pain score of 6 or higher in the last month, (on 0-10 scale).

You may not qualify if:

• Pregnant or breastfeeding patient
• Patients younger than 55 or older than 85 years
• Patients presenting with neurological deficits (including lumbosacral radiculopathy but not solitary radicular pain).
• Patients with history of lumbosacral spine surgery excluding previous lumbar radiofrequency neurotomy
• Patients who have had lumbar radiofrequency neurotomy in the past 6 months
• Patients with the presence of metal hardware or other foreign objects at the lumbosacral spine
• Patients with history of 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 the official language used within the particular sites' location.
• Patients presenting with any severe medical condition preventing the patient from safely and effectively being treated in the study or reporting study outcome per PI decision.
• Patient with extensive scarring of 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
• Any patients with an uncontrolled coagulopathy
• Patients with known osteoporosis with absolute risk of spinal fracture of \>10% over 10 years will be excluded
• Any patients with a history of malignant disease in the past five years
• Patients with rheumatologic diseases causing spine pain that are currently receiving active treatment including steroids, disease modifying drugs, biological agents or immunosuppressants.

Sponsors & Collaborators

• FUSMobile Inc.: lead

Study Sites (5)

Kinetix Medicine

Vancouver, British Columbia, BC V6K 2E4, Canada

Location

Precision Sport & Spine

Oakville, Ontario, L6L 1H5, Canada

Location

Silver Medical Group

Toronto, Ontario, M3H 5S4, Canada

Location

Toronto Western

Toronto, Ontario, M5T 2S8, Canada

Location

Alan Edwards Pain Management Unit - Montreal General Hospital

Montreal, Quebec, H3G 1A4, Canada

Location

Related Publications (1)

• Gofeld M, Smith KJ, Bhatia A, Djuric V, Leblang S, Rebhun N, Aginsky R, Miller E, Skoglind B, Hananel A. Fluoroscopy-guided high-intensity focused ultrasound neurotomy of the lumbar zygapophyseal joints: a prospective, open-label study. Reg Anesth Pain Med. 2025 Jun 10;50(6):464-470. doi: 10.1136/rapm-2024-105345.

  PMID: 38580339 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 11, 2019
• First Posted: October 16, 2019
• Study Start: September 24, 2019
• Primary Completion: October 26, 2022
• Study Completion: March 26, 2023
• Last Updated: December 1, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (5)