Facet Related Low Back Pain Clinical Trial
Official title:
Safety and Initial Feasibility of Using the Neurolyser XR Device for the Treatment of Facet Related Low Back Pain
| Verified date | July 2020 |
| 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 new portable high intensity focused ultrasound device, for noninvasive thermal ablation of medial nerve branches of painful lumbar facet joint/s
| Status | Completed |
| Enrollment | 10 |
| Est. completion date | February 19, 2020 |
| Est. primary completion date | February 28, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility | Inclusion Criteria: 1. Adult male and females, legally able and willing to participate in the study and come for follow-up visits 2. Able and willing to fill the study forms and to communicate with investigator 3. Patient with uni or bilateral lumbar facetogenic pain of > 6 months duration 4. Patients presenting with a) a positive (>70% pain relief) to a previous L1 to L5 lumbar medial branch block and / or b) with a positive (>70% pain relief) to a previous lumbar facet thermal RF denervation within the last 6 months) 5. Average pain score of 4 or higher in the last month, (on a scale of 0 to 10) Exclusion Criteria: 1. Pregnant or breastfeeding patient 2. Patients younger than 18 or older than 80 years 3. Patients presenting with neurological deficits (including lumbosacral radiculopathy but not radicular pain). 4. History of spine surgery 5. Presence of metal hardware at the lumbosacral spine 6. 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) 7. Patients unable to understand and complete the research questionnaires in English or French 8. Any severe medical condition preventing the patient from safely and effectively being treated in the study or reporting study outcome. 9. Patient with extensive scarring in the skin and tissue overlying the treatment area. 10. Patients enrolled in or planned to be enrolled in another clinical trial during the duration of this research project |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Alan Edwards Pain Management Unit - Montreal General Hospital | Montréal | Quebec |
| Lead Sponsor | Collaborator |
|---|---|
| FUSMobile Inc. | Focused Ultrasound Foundation |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | NRS | Reduction in average pain score as measured by a numeric rating scale from 0 (no pain) to 10, worst possible pain | Base line, 2 days 1, 2 & 4 weeks, 3, 6 & 12 months after procedure | |
| Primary | RMD | Reduction in Rolland Morris Disability Questionnaire score | Base line, 1 & 4 weeks, 3, 6 & 12 months after procedure | |
| Primary | Saftey | Safety will be measured by the incidence and severity of treatment related adverse events | Base line, Procedure day, 2 days 1, 2 & 4 weeks, 3, 6 & 12 months after procedure |