Facet Related Low Back Pain
Conditions
Brief summary
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
Detailed description
Study design: Prospective, single arm Timeline: six month enrollment period and 12 months follow-up period. Sites: The study will be conducted at McGill University. Study population: Ten adult patients diagnosed with facet related low back pain. Primary study objective: Safety and efficacy of the Neurolyser XR for the treatment of facet related low back pain. Safety would be evaluated by the incidence and severity of treatment related adverse events Efficacy would be evaluated by the changes in average pain score and Rolland Morris Disability Questionnaire between baseline and 6 months.
Interventions
DEVICEFocused Ultrasound Thermal ablation
Focused Ultrasound Thermal ablation of the Medial Nerve Branch
Sponsors
Focused Ultrasound Foundation
FUSMobile Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single arm, non-randomized
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| NRS | Base line, 2 days 1, 2 & 4 weeks, 3, 6 & 12 months after procedure | Reduction in average pain score as measured by a numeric rating scale from 0 (no pain) to 10, worst possible pain |
| RMD | Base line, 1 & 4 weeks, 3, 6 & 12 months after procedure | Reduction in Rolland Morris Disability Questionnaire score |
| Saftey | Base line, Procedure day, 2 days 1, 2 & 4 weeks, 3, 6 & 12 months after procedure | Safety will be measured by the incidence and severity of treatment related adverse events |
Countries
Canada
Outcome results
None listed