A Randomised Pilot Study to Assess differenCes in tHe Subjects' Experience of stimulAtion-Induced paRaesthesiA Between Two Different Spinal Cord sTimulation dEvices: the Axium® DoRsal Root Ganglion Stimulation System Versus the Prime Advanced Dorsal Column Stimulation System
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Stability of Stimulation Induced Paresthesia
研究概览
简要总结
12-SMI-2014 is a post-market, randomised, pilot study to identify and rate differences in patient experiences with two different types of Spinal Cord Stimulator devices which are routinely used to treat chronic pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is appropriate for SCS implantation according to standard criteria
- •Subject is >18 to <75 years old
- •Subject is able and willing to comply with the follow-up schedule and protocol
- •Subject has chronic (> 6 months) uni/bi-lateral neuropathic pain in the lower limb(s) (below the knee) with predominant foot pain
- •Minimum baseline pain rating of 50 mm on the VAS in the primary region of pain
- •Subject is able to provide written informed consent
排除标准
- •Subject has no other exclusion criteria for SCS implantation according to standard criteria
- •Subject has had corticosteroid therapy at an intended site of stimulation within the past 30 days
- •Subject has had radiofrequency treatment of an intended target DRG within the past 3 months
- •Subject has participated in another clinical study within 30 days
- •Subject has been previously treated with and failed to respond to an implantable neuromodulation therapy
研究组 & 干预措施
Axium SCS System
Implantation with the Axium Neurostimulator
干预措施: Treatment with the Axium SCS system (Device)
Medtronic SCS System
Implantation with the Medtronic Prime Advanced Dorsal Column Stimulation System
干预措施: Treatment with the Medtronic SCS System (Device)
结局指标
主要结局
Stability of Stimulation Induced Paresthesia
时间窗: 3 Months post implantation
A comparative analysis will be made between groups to determine any changes in the intensity of stimulation induced paresthesia in response to changes in body position
Patient Interactions with System
时间窗: 3 Months post implantation
A comparative analysis will be made between groups to determine the number of device interactions patients need to have on average, daily
Specificity of Stimulation Induced Paresthesia
时间窗: 3 Months post implantation
A comparative analysis will be made between groups to determine the percentage of a patients painful and non-painful anatomy that is covered by stimulation induced paresthesia
次要结局
未报告次要终点