High-Intensity Focused Ultrasound Ablation With the Neurolyser XR Device for the Treatment of Chronic Low Back Pain: a Prospective Randomized Double-Blind Sham-Controlled Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 19
- 主要终点
- Procedure and Device Safety up to six months post procedure
研究概览
简要总结
Double arm pivotal study to evaluate the Neurolyser XR as a non-invasive treatment of axial chronic low back pain
详细描述
Study design: Prospective, Double Arm Timeline: Twelve months enrollment period and 6 months follow-up period. Sites: The study will be conducted at 10 sites in the USA Study population: 80 adult subjects diagnosed with facet related low back pain with an additional 10 roll in subjects.
Arms: 40 patients would be treated by the NeurolyserXR and 40 would get a sham treatment Crossover: blinded crossover between the two arms could be done between 1 and 3 months Primary study objective: Safety and efficacy of the Neurolyser XR for the treatment of chronic low back pain secondary to zygapophyseal joint syndrome.
Safety is measured by the incidence and severity of treatment related adverse events.
Efficacy is measured by pain numerical rating scale
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The sham procedure would be done using the same system and setup. Randomization would be done using an EDC system and no person at the room would know if the procedure is a treat or sham procedure.
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 50 to 85 years old, legally able and willing to participate in the study and all follow-up visits
- •Able and willing to complete the research questionnaires and to communicate with investigator and research team
- •Individual with current bilateral or unilateral low back pain of > 6 months duration
- •Individual whose back pain is alleviated by recumbency or comfortable sitting position
- •Individual presenting with a) a positive (>80% pain relief) to a previous, double, lumbar medial branch block (within the last 12 months) and/or b) with a positive (>70% pain relief lasting more than 6 months) to the most recent lumbar facet thermal radiofrequency denervation
- •Average low back pain score of 6 or higher in the last month (on 0-10 scale) with activity
排除标准
- •Individuals who are pregnant or breastfeeding
- •Individuals younger than 50 or older than 85 years
- •BMI greater than 40, or individuals with at least one of the planned targets outside the Neurolyser XR treatment envelope as seen on treatment day on a lateral X-ray scan taken before the treatment.
- •Individuals presenting with neurological deficits (including lumbosacral radiculopathy but not solitary radicular pain)
- •Individuals with history of lumbar or lumbosacral spine surgery
- •Individuals who have had lumbar radiofrequency neurotomy in the past 6 months
- •Individuals with history of lumbar spine pathology that may increase procedural risk and/or influence symptoms and/or generate unrelated adverse event (per investigator's discretion)
- •Individuals presenting with any severe medical condition preventing them from participation (per investigator's discretion) (Example: inability to lay prone)
- •Individuals with extensive scarring of the skin and tissue overlying the treatment area
- •Individuals enrolled in or planned to be enrolled in another clinical trial during the duration of this research project
- •Any Individuals with an uncontrolled coagulopathy
- •Individuals with known osteoporosis with absolute risk of spinal fracture of > 10% over 10 years
- •Any Individuals with a history of malignant disease in the past five years or any individuals with clinical history suggestive of new/previously unknown malignancy and pathological pain who require further work up or is currently undergoing work up
- •Individuals with rheumatologic diseases causing spine pain that are currently receiving active treatment including steroids, disease modifying drugs, biological agents or immunosuppressants
- •Individuals known for concomitant psychiatric disorders, excluding compensated mood disorders
- •Individuals with first-degree family member already enrolled in this study
- •Individual who is scheduled for any interventional/surgical procedure within 6 months from the treatment date excluding trivial surgeries (e.g., cataract, carpal tunnel release)
- •Individuals diagnosed with co-morbid multifocal chronic pain (e.g. fibromyalgia, generalized osteoarthritis)
- •Individuals with other chronic pain that is 2 or more points higher on the NRS score than the participants low back pain
- •Individuals who have had a steroid injection within the last 2 months from date of enrollment at the location of the planned treatment
- •Any individuals with clinical or radiographic evidence of dynamic instability of the lumbar spine
结局指标
主要结局
Procedure and Device Safety up to six months post procedure
时间窗: 6 months after procedure
Safety will be measured by the incidence and severity of treatment related adverse events
NRS
时间窗: 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
次要结局
- Oswestry Disability Index (ODI)(Time Frame: Base line, 1, & 4 weeks, 3 & 6 months after procedure)
- Patient Global Impression of Change (PGIC)(Time Frame: Base line, 1, & 4 weeks, 3 & 6 months after procedure)