NCT02143791已完成不适用
A Post-market Study Evaluating the Prodigy Neuromodulation System for the Management of Failed Back Surgery Syndrome or Chronic Intractable Pain of the Trunk and/or Limbs.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 33
- 主要终点
- Percentage Change From Baseline in Overall VAS at 3 Months
研究概览
简要总结
The purpose of this study is to confirm long term efficacy and safety of the ProdigyTM neuromodulation system in the management of failed back surgery syndrome or chronic intractable pain of the trunk and/or limbs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Patient with chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome or intractable low back and/or leg pain
- •Patient diagnosed with radiculopathy
- •Patient diagnosed with neuropathic pain
- •Patient is considered by the investigator as a candidate for implantation of a SCS system
- •Patient is ≥ 18 years of age
- •Patient must be willing and able to comply with study requirements
- •Patient must indicate his/her understanding of the study and willingness to participate by signing an appropriate Informed Consent Form
排除标准
- •Patient is diagnosed with ischemic pain
- •Patient is diagnosed with arachnoiditis
- •Patient is diagnosed with complex regional pain syndrome (CRPS I and II)
- •Patient is diagnosed with peripheral vascular disease (PVD)
- •Patient is diagnosed with diabetic neuropathic pain
- •Patient is diagnosed with chronic migraine
- •Patient is immune-compromised
- •Patient has history of cancer requiring active treatment in the last 6 months
- •Patient has a documented history of substance abuse (narcotics, alcohol, etc.) or substance dependency in the last 6 months
- •Patients with a SCS system or implantable infusion pump implanted previously
- •Patient has a life expectancy of less than one year
- •Patient is pregnant or is planning to become pregnant during the duration of the investigation
- •Patient is unable to comply with the follow up schedule
- •Patient needing legally authorized representative
- •Patient unable to read and write
- •Patient is currently participating in another clinical investigation with an active treatment arm.
结局指标
主要结局
Percentage Change From Baseline in Overall VAS at 3 Months
时间窗: 3 months
Percentage change in pain relief at the 3- month follow-up visit compared to baseline visit, as measured by the Visual Analog Scale (VAS). The VAS scale with a 10 cm (or 100 mm) line to indicate pain intensity progression with no pain (0) on the left end and worst pain (100) on the right end. Percent change is calculated as "\[(post baseline baseline)/baseline\] \*100%" with positive numbers to represent increases and negative numbers to represent decreases.
次要结局
- Rate of Serious Adverse Events and/or Procedure/Device-related Adverse Events(from enrollment to 12 months follow up)
- Change in Pain Catastrophizing Scale(12 Months)
- Pain Relief(12 Months)
- Number of Participants With Analgesic Reduction(12 Months)
- Change in Quality of Life(Baseline and 12 Months)
- Paresthesia Mapping at 3 Months Compared to the Empower Study(3 Months)
研究者
研究点 (33)
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