Facet Syndrome of Lumbar Spine Clinical Trial
Official title:
Safety and Initial Feasibility of Using the Neurolyser XR Device for the Treatment of Axial Chronic Low Back Pain
Verified date | November 2022 |
Source | FUSMobile Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Active, not recruiting |
Enrollment | 30 |
Est. completion date | March 26, 2023 |
Est. primary completion date | October 26, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 55 Years to 85 Years |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
Canada | Alan Edwards Pain Management Unit - Montreal General Hospital | Montréal | Quebec |
Canada | Precision Sport & Spine | Oakville | Ontario |
Canada | Silver Medical Group | Toronto | Ontario |
Canada | Toronto Western | Toronto | Ontario |
Canada | Kinetix Medicine | Vancouver | British Columbia |
Lead Sponsor | Collaborator |
---|---|
FUSMobile Inc. |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | Lesion Size | Lesion size and location as shown in MRI Image, 2 days post treatment. | 2 days post procedure | |
Secondary | Oswestry Disability Index (ODI) | Low Back Pain Questionnaire (Range: 0% to 100%) | Time Frame: Base line, 1, & 4 weeks, 3 & 6 months after procedure | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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