Field Shape and Amplitude Sensitivity Exploratory Study (CONTOUR Study)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Patient Preferred Field Shape
研究概览
简要总结
The study aims to better understand how to program Spinal Cord Stimulation for the treatment of chronic low back and leg pain
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •Documented average low back pain intensity of at least 6 out of 10 and greater or equal than average leg pain intensity over 7 days during screening (Numerical Rating Scale)
- •Stable daily pain-related medication prescription and intake of ≤100mg morphine-equivalents
- •Capacity to describe and rate pain intensity, complete study measurements, and use the study device (e.g. patient remote control, charger, diary ratings) (physician discretion)
排除标准
- •Presence of pain or psychological condition that in the opinion of the investigator may interfere with the subject's ability to rate their pain and communicate such ratings
- •Previous Spinal Cord Stimulation trial or is already implanted with an active implantable device(s) (e.g. pacemaker, drug pump, implantable pulse generator)
研究组 & 干预措施
Alternative then bipolar field shape stimulation
Boston Scientific's Precision SPECTRA™ Spinal Cord Stimulation System: Spinal cord stimulation for the management of chronic neuropathic pain programmed with alternative field shape stimulation for 21 days, then bipolar stimulation for 21 days
干预措施: Boston Scientific's Precision SPECTRA™ Spinal Cord Stimulation System (Device)
Bipolar then alternative field shape stimulation
Boston Scientific's Precision SPECTRA™ Spinal Cord Stimulation System: Spinal cord stimulation for the management of chronic neuropathic pain programmed with bipolar stimulation for 21 days, then alternative field shape stimulation for 21 days
干预措施: Boston Scientific's Precision SPECTRA™ Spinal Cord Stimulation System (Device)
结局指标
主要结局
Patient Preferred Field Shape
时间窗: 42 days post randomization
Number of participants preferring bipolar field shape and alternative field shape
次要结局
未报告次要终点