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

Last updated: November 28, 2022
Sponsor: FUSMobile Inc.
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Chronic Pain

Treatment

N/A

Clinical Study ID

NCT04129034
LBP-002
  • Ages 55-85
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Adult male and females >55 years of age legally able and willing to participate in thestudy and come for follow-up visits
  2. Able and willing to fill the research questionnaires and to communicate withinvestigator 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 ordouble, 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 lumbarfacet thermal radiofrequency denervation.
  6. Average pain score of 6 or higher in the last month, (on 0-10 scale).

Exclusion

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 radiculopathybut not solitary radicular pain).
  4. Patients with history of lumbosacral spine surgery excluding previous lumbarradiofrequency 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 thelumbosacral 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 discretionof the study PI)
  8. Patients unable to understand and complete the research questionnaires in the officiallanguage used within the particular sites' location.
  9. Patients presenting with any severe medical condition preventing the patient fromsafely and effectively being treated in the study or reporting study outcome per PIdecision.
  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 theduration 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 10years 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 receivingactive treatment including steroids, disease modifying drugs, biological agents orimmunosuppressants.
  16. Patients known for concomitant psychiatric disorders, excluding mood disorders.
  17. Patients presenting with concomitant mood disorders (deemed severe by the researchphysician).
  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 monthsfrom screening date
  20. Patients diagnosed with co-morbid multifocal chronic pain (e.g., fibromyalgia)

Study Design

Total Participants: 30
Study Start date:
September 24, 2019
Estimated Completion Date:
March 26, 2023

Study 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.

Connect with a study center

  • Kinetix Medicine

    Vancouver, British Columbia BC V6K 2E4
    Canada

    Site Not Available

  • Precision Sport & Spine

    Oakville, Ontario L6L 1H5
    Canada

    Site Not Available

  • Silver Medical Group

    Toronto, Ontario M3H 5S4
    Canada

    Site Not Available

  • Toronto Western

    Toronto, Ontario M5T 2S8
    Canada

    Site Not Available

  • Alan Edwards Pain Management Unit - Montreal General Hospital

    Montréal, Quebec H3G 1A4
    Canada

    Site Not Available

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