NCT01990287终止不适用
SENSE (Subcutaneous and Epidural Neuromodulation System Evaluation)Study for the Treatment of Chronic Low Back and Leg Pain
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 38
- 试验地点
- 56
- 主要终点
- Safety
研究概览
简要总结
The purpose of the study is to demonstrate safety and efficacy of spinal cord stimulation with peripheral nerve field stimulation for the treatment of chronic low back and leg 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
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is 22 years of age or older
- •Subject has chronic low back and leg pain secondary to Failed Back Surgery Syndrome (FBSS)
- •Subject has an average score of 6 or higher for average daily overall pain on the Numerical Rating Scale (NRS) based on the 7 day pain diary
- •Subject has attempted "best" medical therapy and has tried and failed at least three documented medically supervised treatments (including, but not limited to physical therapy, acupuncture, etc.) and has failed medication treatment from at least two different classes
- •Subject's pain-related medication regimen is stable 4 weeks prior to the baseline evaluation
- •Subject agrees not to add or increase pain-related medication throughout the 12 week randomized evaluation phase of the study (starting at activation)
排除标准
- •Subject currently participating in a clinical investigation that includes an active treatment arm
- •Subject has been implanted with a previous neuromodulation system (PNfS, SCS-PNfS or SCS) or participated in a trial for a neuromodulation system
- •Subject's overall Beck Depression Inventory II Score is > 24 or has a score of 3 on question 9 relating to suicidal thoughts or wishes at the baseline visit
- •Subject with an infusion pump or any implantable neurostimulator device
- •Subject has an existing medical condition that is likely to require repetitive MRI evaluation in the future (i.e. epilepsy, stroke, multiple sclerosis, acoustic neuroma, tumor)
- •Subject has an existing medical condition that is likely to require the use of diathermy in the future
- •Subject has peripheral vascular disease
- •Subject is immunocompromised
- •Subject has documented history of allergic response to titanium or silicone
- •Subject has a documented history of substance abuse (narcotics, alcohol, etc.) or substance dependency in the 6 months prior to baseline data collection
- •Female candidates of child bearing potential that are pregnant (confirmed by positive pregnancy test)
结局指标
主要结局
Safety
时间窗: 6 months
Evaluation of device or procedure related adverse events
Efficacy
时间窗: 3 months
Responder rate in SCS-PNfS vs SCS alone
次要结局
- Quality of Life(3 months)
- Functional Disability(3 months)
- Worst pain(3 months)
- Rescue medication usage(3 months)
研究者
研究点 (56)
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