Safety and Initial Feasibility of Using the Neurolyser XR Device for the Treatment of Axial Chronic Low Back Pain
Unknown statusNot applicableNCT04129034
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Brief summary (from the registry)
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 details
- Official title
- Safety and Initial Feasibility of Using the Neurolyser XR Device for the Treatment of Axial Chronic Low Back Pain
- Conditions
- Facet Syndrome of Lumbar Spine
- Interventions
- Device: Neurolyser XR
- Sponsor
- FUSMobile Inc.
- Start date
- 2019-09-24
- Primary completion
- 2022-10-26
- Sex
- All
- Age range
- from 55 Years to 85 Years
- Results posted
- No results posted in this snapshot
- Countries
- Canada
- Total sites listed
- 5
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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 p…
Canadian sites (5)
| Facility | City | Province |
|---|---|---|
| Kinetix Medicine | Vancouver | British Columbia |
| Precision Sport & Spine | Oakville | Ontario |
| Silver Medical Group | Toronto | Ontario |
| Toronto Western | Toronto | Ontario |
| Alan Edwards Pain Management Unit - Montreal General Hospital | Montreal | Quebec |
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04129034