Restore Claims Characterization Study

MedtronicNeuro8 个研究点分布在 1 个国家目标入组 100 人开始时间: 2005年1月最近更新: 2009年1月21日

适应症

试验速览

阶段: 4 期
状态: 已完成
发起方: MedtronicNeuro
入组人数: 100
试验地点: 8
主要终点: The primary endpoint is to assesses the pain coverage capability of the RESTORE SCS system.

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to characterize the pain coverage capability of the RESTORE spinal cord stimulation (SCS) and assess health outcomes.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Diagnostic
盲法: Single

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

•Has chronic refractory pain associated with one of the conditions currently approved for spinal cord stimulation as follows: Failed Back Syndrome, Degenerative Disk Disease (DDD), Herniated Disk pain refractory to conservative and surgical interventions, Peripheral Causalgia, Complex Regional Pain Syndrome (CRPS) or Reflex Sympathetic Dystrophy (RSD).
•Primary pain in the lower half of the body.

排除标准

•Requires, or will in the future, diathermy treatments.
•Had implanted spinal cord stimulation system within the last six months.

结局指标

主要结局

The primary endpoint is to assesses the pain coverage capability of the RESTORE SCS system.

次要结局

Secondary outcome measures include pain relief, quality of life, function, patient and physician acceptance.

研究者

发起方

MedtronicNeuro

申办方类型

Industry

研究点 (8)

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