A Multi-Center Controlled Study to Characterize the Real-world Outcomes of High Rate Spinal Cord Stimulation Therapy Using Boston Scientific (BSC) PRECISION Spinal Cord Stimulator System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 5
- 主要终点
- Percentage of Low Back Pain Responders
研究概览
简要总结
The primary objective of this study is to characterize the real-world outcomes of spinal cord stimulation (SCS) therapy as an aid in the management of chronic intractable pain of the trunk, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back pain using the Boston Scientific (BSC) PRECISION Spinal Cord Stimulator System with MultiWave Technology.
详细描述
The purpose of this study is to characterize the real-world outcomes of spinal cord stimulation (SCS) therapy as an aid in the management of chronic intractable pain of the trunk, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back pain using the Boston Scientific (BSC) PRECISION Spinal Cord Stimulator System with MultiWave Technology.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Complaint of persistent or recurrent low back pain for at least 180 days prior to Screening
- •Willing and able to comply with all protocol-required procedures and assessments/evaluations
- •Subject signed a valid, ethics committee (EC)-approved informed consent form (ICF) provided in local language
排除标准
- •High surgical risk
- •Previous spinal cord stimulation trial or is already implanted with an active implantable device(s) (e.g. pacemaker, drug pump, implantable pulse generator)
- •A female who is pregnant, is breastfeeding, or is of childbearing potential and planning to get pregnant during the course of the study or not using adequate contraception.
- •Participating (or intends to participate) in another drug or device clinical trial that may influence the data that will be collected for this study
- •Any diagnosis or condition that, in the clinician's best judgment, might confound reporting of study outcomes
结局指标
主要结局
Percentage of Low Back Pain Responders
时间窗: 3 months
Percentage of low back pain responders at 3 months post-activation with no increase in opioids from Baseline to 3 months post-activation
次要结局
未报告次要终点