Safety and Initial Feasibility of Using the Neurolyser XR Device for the Treatment of Facet Related Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- NRS
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult male and females, legally able and willing to participate in the study and come for follow-up visits
- •Able and willing to fill the study forms and to communicate with investigator
- •Patient with uni or bilateral lumbar facetogenic pain of > 6 months duration
- •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)
- •Average pain score of 4 or higher in the last month, (on a scale of 0 to 10)
排除标准
- •Pregnant or breastfeeding patient
- •Patients younger than 18 or older than 80 years
- •Patients presenting with neurological deficits (including lumbosacral radiculopathy but not radicular pain).
- •History of spine surgery
- •Presence of metal hardware at the lumbosacral spine
- •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 English or French
- •Any severe medical condition preventing the patient from safely and effectively being treated in the study or reporting study outcome.
- •Patient with extensive scarring in 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
结局指标
主要结局
NRS
时间窗: 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
时间窗: Base line, 1 & 4 weeks, 3, 6 & 12 months after procedure
Reduction in Rolland Morris Disability Questionnaire score
Saftey
时间窗: 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
次要结局
未报告次要终点