Safety and Initial Feasibility of Using the Neurolyser XR Device for the Treatment of Sacroiliac Joint Related Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Effectiveness per pain score using numerical rating scale of 0 to 10
研究概览
简要总结
Pilot study to evaluate the safety and the effectiveness of the Neurolyser XR as a treatment for sacroiliitis
详细描述
Pilot, Interventional, Prospective, Open label, Single Arm study to evaluate Non-invasive thermal ablation of the posterior sacral nerve branches as a treatment of painful sacroiliac joint (SIJ) using High Intensity Focused Ultrasound delivered by the Neurolyser XR.
Patient would be treated and then followed for up to 6 months. Primary safety endpoint will be measured by the incidence and severity of treatment related adverse events Primary effectiveness endpoint will be measured by the changes in average pain score and Rolland Morris Disability Questionnaire between baseline and 6 and 12 months
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 research questionnaires and to communicate with investigator and research team
- •Patient with bilateral or unilateral sacroiliac joint pain of > 6 months duration
- •Patients presenting with a) a positive (>70% pain relief) to a previous nerve ablation procedure of the sacroiliac joint and / or b) with a positive (>70% pain relief) to a previous nerve block procedure of the sacroiliac joint within the last six months)
- •Average pain score of 4 or higher in the last month, (on 0-10 scale).
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 solitary radicular pain).
- •Patients with history of lumbar and / or sacral spine surgery
- •Patients with the presence of metal hardware at the lumbosacral spine
- •Patients with history of pelvic 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 Hebrew.
- •Patients presenting with 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
Effectiveness per pain score using numerical rating scale of 0 to 10
时间窗: Baseline throughout the follow-up period of six months
Pain reduction would be measured using numerical rating scale of 0 to 10 to evaluate pain and brief pain inventory questioner
Safety per adverse events
时间窗: Baseline throughout the follow-up period of six months
Measured by the incidence and severity of treatment related adverse events
次要结局
- Assess self-rated physical disability caused by low back pain(Baseline throughout the follow-up period of six months)
- Opioid intake dosage using morphine equivalency conversion(Baseline throughout the follow-up period of six months)