Status:
UNKNOWN
Safety and Initial Feasibility of Using the Neurolyser XR Device for the Treatment of Axial Chronic Low Back Pain
Lead Sponsor:
FUSMobile Inc.
Conditions:
Facet Syndrome of Lumbar Spine
Eligibility:
All Genders
55-85 years
Phase:
NA
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
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 West...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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.
- Patients known for concomitant psychiatric disorders, excluding mood disorders.
- Patients presenting with concomitant mood disorders (deemed severe by the research physician).
- Patients with a first-degree family member already enrolled in this study.
- Patient who is scheduled for any interventional/surgical procedure within 3 months from screening date
- Patients diagnosed with co-morbid multifocal chronic pain (e.g., fibromyalgia)
Key Trial Info
Start Date :
September 24 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 26 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04129034
Start Date
September 24 2019
End Date
March 26 2023
Last Update
December 1 2022
Active Locations (5)
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1
Kinetix Medicine
Vancouver, British Columbia, Canada, BC V6K 2E4
2
Precision Sport & Spine
Oakville, Ontario, Canada, L6L 1H5
3
Silver Medical Group
Toronto, Ontario, Canada, M3H 5S4
4
Toronto Western
Toronto, Ontario, Canada, M5T 2S8