Spinal Cord Stimulation System in the Treatment of Chronic Pain
试验速览
- 阶段
- 不适用
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- The difference of Visual-analogue scale (VAS) between the experimental group and the control group
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of spinal cord stimulation (SCS) using the PINS spinal cord stimulator device for chronic and intractable pain.
详细描述
Adult patients with chronic intractable pain of the trunk and/or limbs who are candidates for a treatment with spinal cord stimulation will be prospectively randomized into 2 arms. Spinal cord stimulation parameters are programmed and adjusted during outpatient clinic visits, within the normal clinical practice.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have been diagnosed with chronic, intractable pain of the trunk and/or limbs which has been refractory to conservative therapy for a minimum of 3 months.
- •Be 18 years of age or older at the time of enrollment
- •Be willing and able to comply with study-related requirements, procedures, and visits
- •Be willing and capable of giving informed consent
排除标准
- •Pregnancy or potential for with unwillingness to use contraception
- •Have a current diagnosis of a coagulation disorder, bleeding diathesis
- •Have evidence of psychiatric or cognitive disorder, who are unable to cooperate with surgery and program control
- •Have a life expectancy of less than 1 year
- •Have a condition currently requiring or likely to require the use of diathermy
- •Other inappropriate situations determined by the researcher
结局指标
主要结局
The difference of Visual-analogue scale (VAS) between the experimental group and the control group
时间窗: 13 weeks
Pain will be evaluated in the different groups according to the Visual-analogue scale (VAS) varying from 0 to 10 with a higher score indicating a higher level of pain.
次要结局
- Changes in VAS(4、12、24 weeks)
- Sleep Quality(4、12、24 weeks)
- Change in quality of life as measured by SF-36(4、12、24 weeks)
- Changes in Beck Depression Inventory(4、12、24 weeks)
- Number of subjects with adverse events(24 weeks)