NL-OMON42937已完成不适用
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 - VELOCITY
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •-Complaint of persistent or recurrent low back pain for at least 180 days prior to Screening
- •-No back surgery within 6 months prior to Screening
- •-Average low back pain intensity of 6 or greater on a 0-10 numerical rating scale during Screening (NRS) as evaluated by interview
- •-Baseline Oswestry Disability Index score >40 and <81
- •-18 years of age or older when written informed consent is obtained
排除标准
- •-Average leg pain is greater than or equal to average low back pain during Screening (NRS).
- •-Radiographic evidence of spinal instability requiring fusion
- •-Require implantation of lead(s) in the cervical epidural space
- •-Requires implantation of paddle-style SCS lead(s) via a laminotomy and/or laminectomy
- •-Previous spinal cord stimulation trial or is already implanted with an active implantable device(s) (e.g. pacemaker, drug pump, implantable pulse generator)
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