A Randomized Controlled Study to Evaluate the Safety and Effectiveness of the Precision Spinal Cord Stimulator Systems Adapted for High-Rate Spinal Cord Stimulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 383
- 试验地点
- 20
- 主要终点
- Proportion of Responders as Determined by the Cumulative Distribution Function (CDF) of Response Rates
研究概览
简要总结
To evaluate the safety and effectiveness of the Precision Spinal Cord Stimulator Systems Adapted for High-Rate Spinal Cord Stimulation as an aid in the management of chronic intractable pain
详细描述
To evaluate the safety and effectiveness of high rate spinal cord stimulation (HR-SCS) therapy as an aid in the management of chronic intractable pain of the trunk using the Boston Scientific (BSC) PRECISION Spinal Cord Stimulator Systems Adapted for High-Rate Spinal Cord Stimulation
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
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have been diagnosed with chronic, intractable pain of the trunk (NRS ≥ 5) which has been refractory to conservative therapy for a minimum of 90 days.
- •Be an appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the implanting physician
- •Be 22 years of age or older at the time of enrollment
- •Be willing and capable of giving informed consent
- •Be willing and able to comply with study-related requirements, procedures, and visits
排除标准
- •Have a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the Investigator
- •Have evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance of intervention and/or ability to evaluate treatment outcome, as determined by a psychologist
- •Have previous spinal cord stimulation trial or is already implanted with an active implantable device(s) (e.g. pacemaker, drug pump, implantable pulse generator)
- •Have a current systemic infection, or local infection in close proximity to anticipated surgical field
- •Pregnant or plan to get pregnant during the course of the study or not using adequate contraception.
- •Be participating in another clinical study that may influence the data collected for the study
研究组 & 干预措施
High Rate Spinal Cord Stimulation
PRECISION SCS Adapted for High-Rate SCS
干预措施: PRECISION SCS Adapted for High-Rate SCS (Device)
Commercial Rate Spinal Cord Stimulation
PRECISION SCS Adapted for High-Rate SCS
干预措施: PRECISION SCS Adapted for High-Rate SCS (Device)
结局指标
主要结局
Proportion of Responders as Determined by the Cumulative Distribution Function (CDF) of Response Rates
时间窗: 3 months post-activation
Cummulative distribution function (CDF) of response rates from 0% - 100% numerical rating score (NRS) to derive the entire range of possible responder definitions. This allows us to determine the range of success for all responder rates without the need to identify a certain cutoff (for example, use a 50% responder rate). A comparison between the two CDF's was performed by comparing the area under the curves since area between CDFs is equal to the mean difference in low back pain reduction for CR-SCS and HR-SCS. Hence, it can be used to estimate the true underlying difference in responder rates between CR-SCS and HR-SCS
次要结局
未报告次要终点