Safety and Initial Feasibility of Using the Neurolyser XR Device for the Treatment of Axial Chronic Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 10
- 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 high intensity focused ultrasound device, for non-invasive treatment of axial chronic low back pain
详细描述
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 Western, Silver Medical Group, Precision Sport & Spine, Kinetix Integrated Orthopaedic & Regenerative Medicine
Study population: Thirty adult patients diagnosed with facet related low back pain.
Primary study objective: Safety and efficacy of the Neurolyser XR for the treatment of chronic low back pain secondary to zygapophyseal joint syndrome.
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
- 55 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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)
结局指标
主要结局
NRS
时间窗: Time Frame: Base line, 2 days 1, 2 & 4 weeks, 3 & 6 months after procedure
Change in average pain score as measured by a numeric rating scale from 0 (no pain) to 10, worst possible pain
Procedure and Device Safety at six months as measured by measured by the incidence and severity of treatment related adverse events
时间窗: Time Frame: 6 months after procedure
Safety will be measured by the incidence and severity of treatment related adverse events
次要结局
- Patient Global Impression of Change (PGIC)(Time Frame: Base line, 1, & 4 weeks, 3 & 6 months after procedure)
- Lesion Size(2 days post procedure)
- Oswestry Disability Index (ODI)(Time Frame: Base line, 1, & 4 weeks, 3 & 6 months after procedure)
- Short Form 12 (SF-12)(Time Frame: Base line, 1, & 4 weeks, 3 & 6 months after procedure)
- Procedure and Device Safety as measured by 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)