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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Facet Syndrome of Lumbar Spine
• Intervention / Treatment: Device: Neurolyser XR

Detailed Description

Study design: Prospective, single arm

Timeline: six month enrollment period and 6 months follow-up period.

Sites: The study will be conducted at five sites in Canada: McGill University, Toronto Western, Silver Medical Group, Precision Sport & Spine, Kinetix Integrated Orthopaedic & Regenerative Medicine

Study population: Thirty adult patients diagnosed with facet related low back pain.

Primary study objective: Safety and efficacy of the Neurolyser XR for the treatment of chronic low back pain secondary to zygapophyseal joint syndrome.

Safety is measured by the incidence and severity of treatment related adverse events.

Efficacy is measured by the changes in pain severity at the treatment area, using a numerical rating scale (NRS), of 0 to 10 between baseline and 6 months.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, BC V6K 2E4
      • Kinetix Medicine
  • Ontario
    • Oakville, Ontario, Canada, L6L 1H5
      • Precision Sport & Spine
    • Toronto, Ontario, Canada, M3H 5S4
      • Silver Medical Group
    • Toronto, Ontario, Canada, M5T 2S8
      • Toronto Western
  • Quebec
    • Montréal, Quebec, Canada, H3G 1A4
      • Alan Edwards Pain Management Unit - Montreal General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Adult male and females >55 years of age legally able and willing to participate in the study and come for follow-up visits
2. Able and willing to fill the research questionnaires and to communicate with investigator and research team
3. Patient with bilateral or unilateral low back pain of > 6 months duration
4. Patients whose back pain is alleviated by recumbency or comfortable sitting position
5. 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.
6. Average pain score of 6 or higher in the last month, (on 0-10 scale).

Exclusion Criteria:

1. Pregnant or breastfeeding patient
2. Patients younger than 55 or older than 85 years
3. Patients presenting with neurological deficits (including lumbosacral radiculopathy but not solitary radicular pain).
4. Patients with history of lumbosacral spine surgery excluding previous lumbar radiofrequency neurotomy
5. Patients who have had lumbar radiofrequency neurotomy in the past 6 months
6. Patients with the presence of metal hardware or other foreign objects at the lumbosacral spine
7. 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)
8. Patients unable to understand and complete the research questionnaires in the official language used within the particular sites' location.
9. 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.
10. Patient with extensive scarring of the skin and tissue overlying the treatment area.
11. Patients enrolled in or planned to be enrolled in another clinical trial during the duration of this research project
12. Any patients with an uncontrolled coagulopathy
13. Patients with known osteoporosis with absolute risk of spinal fracture of >10% over 10 years will be excluded
14. Any patients with a history of malignant disease in the past five years
15. Patients with rheumatologic diseases causing spine pain that are currently receiving active treatment including steroids, disease modifying drugs, biological agents or immunosuppressants.
16. Patients known for concomitant psychiatric disorders, excluding mood disorders.
17. Patients presenting with concomitant mood disorders (deemed severe by the research physician).
18. Patients with a first-degree family member already enrolled in this study.
19. Patient who is scheduled for any interventional/surgical procedure within 3 months from screening date
20. Patients diagnosed with co-morbid multifocal chronic pain (e.g., fibromyalgia)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Treatment; Thermal ablation of the medial nerve branch using High Intensity Focused Ultrasound	Device: Neurolyser XR; Non-Invasive Thermal Ablation of the Medial Branch Nerves

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oswestry Disability Index (ODI)	Low Back Pain Questionnaire (Range: 0% to 100%)	Time Frame: Base line, 1, & 4 weeks, 3 & 6 months after procedure
Patient Global Impression of Change (PGIC)	Patient Global Impression of Change (Range: 1 to 7)	Time Frame: Base line, 1, & 4 weeks, 3 & 6 months after procedure
Lesion Size	Lesion size and location as shown in MRI Image, 2 days post treatment.	2 days post procedure
Short Form 12 (SF-12)	A multipurpose short form survey with 12 questions (Range: 0 to 100)	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	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 months after procedure

Collaborators and Investigators

• Sponsor: FUSMobile Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 24, 2019
• Primary Completion (ACTUAL): October 26, 2022
• Study Completion (ANTICIPATED): March 26, 2023

Study Registration Dates

• First Submitted: October 11, 2019
• First Submitted That Met QC Criteria: October 14, 2019
• First Posted (ACTUAL): October 16, 2019

Study Record Updates

• Last Update Posted (ACTUAL): December 1, 2022
• Last Update Submitted That Met QC Criteria: November 28, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: chronic low back pain; zygapophyseal joint syndrome; Facet syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Disease; Syndrome; Back Pain; Low Back Pain
• Other Study ID Numbers: LBP-002

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