NL-OMON21128尚未招募不适用
A Clinical Study to Evaluate the Clinical Performance of HF10™ SCS Therapy in Failed Back Surgery Syndrome Patients in the Dutch Healthcare System
evro Corp.0 个研究点目标入组 55 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 55
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •1.Diagnosed with Failed Back Surgery Syndrome which has been refractory to conservative therapy for a minimum of 3 months and indicated for SCS as per Dutch SCS guidelines and as approved by the Dutch insurance companies
- •2.Average leg pain intensity of ¡Ý 5 out of 10 cm on the Visual Analog Scale (VAS) at enrollment
- •3.Average back pain intensity ¡Ü average leg pain intensity on the Visual Analog Scale (VAS) at enrollment
- •4.An adult (¡Ý 18 years of age) at time of enrollment
排除标准
- •1.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,
- •2.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
- •3.A diagnosis of scoliosis that precludes lead placement
- •4.Radiographic evidence of mechanical spinal instability requiring fusion.
- •5.Pain that is significantly exacerbated by activity or significantly alleviated by rest
- •6.Benefitting within 30 days prior to enrollment from an interventional procedure and/or surgery to treat back and/or leg pain
- •7.Existing drug pump and/or SCS system or another active implantable device such as a pacemaker (switched On or Off)
- •8.Prior experience with SCS
- •9.Pregnant
研究者
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