An Observational Cohort Study to Assess the Long Term Effectiveness of Dorsal Root Ganglion Stimulation for Chronic Pain in the Upper Limb(s)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 3
- 主要终点
- Pain reduction
研究概览
简要总结
There are no studies as yet specifically investigating the application of DRG stimulation in the treatment of chronic pain affecting the upper limbs. The investigators propose to investigate the effect of dorsal root stimulation in patients with chronic hand or upper limb pain.
详细描述
Dorsal Root Ganglion (DRG) stimulation is a form of Spinal Cord Stimulation (SCS), which has been available and used for the treatment of chronic pain in Europe since late 2011. Clinical practice and pre/post market studies have shown that stimulation of the DRG can significantly reduce chronic intractable pain of various aetiologies. However, there are no studies as yet specifically investigating the application of DRG stimulation in the treatment of chronic pain affecting the upper limbs. Furthermore, there are very few studies of SCS generally, in an upper limb pain population, despite this being a group often referred for and treated with SCS in tertiary, interventional pain practices. Due to several limitations of traditional SCS systems, chiefly concerning the stability of stimulation induced paraesthesia, DRG stimulation is being increasingly utilised in its place for this condition.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Pain reduction
时间窗: 5 years
Pain measured on a 10cm Visual Analogue Scale (VAS), where 0 \[no pain\] and 10 \[worst possible pain\] imaginable
次要结局
- Safety(5 years)
- Subject satisfaction(5 years)
- Pain medication utilization(5 years)
- Sleep Quality(5 years)
- Comfort of stimulation(5 years)
- Quality of life(5 years)
研究者
Jennifer Breel
Research coordinator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)