Conus Medullaris Stimulation With 5 Columns Lead Versus Medical Treatment in Refractory Pudendal Neuralgia: a Randomized, Open, Controlled, Multicenter Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 14
- 主要终点
- Improvement of the sitting time from baseline to 6 months of follow-up
研究概览
简要总结
Pudendal neuralgia is a frequent diagnosis in pain clinics. This perineal pain has devastating effects on patient's quality of life. Today, 30% of patients are refractory to pain management and surgical procedure.
The neuropathic characteristics of the pain in these patients lead us to test the efficiency of spinal cord stimulation at conus medullaris level.
In our published preliminary study involving 27 patients with refractory pudendal neuralgia, we demonstrated that 74% of patients implanted with stimulation electrodes at the conus medullaris responded to stimulation.
The primary objective of the present trial is to assess through a randomized, parallel group design, the effectiveness of spinal cord stimulation at the conus medullaris using pentapolar surgical lead ((TM)Penta, St Jude medical ANS) versus medical treatment alone on sitting time in refractory pudendal neuralgia.
详细描述
In this national multicenter prospective open label trial, patients will be randomized 1:1 to experimental group (CMS group : Conus Medullaris Stimulation using pentapolar surgical lead, plus optimal medical management) or to control group (OMM group : optimal medical management alone) and followed for 12 months, in intention to treat.
42 patients suffering of refractory pudendal neuralgia will be included. Optimal medical management will be prescribed by algologists in both groups according to patient pain relief.
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Improvement of the sitting time from baseline to 6 months of follow-up
时间窗: At 6 months of follow-up
Sitting time is measured by a sitting time diary (in minutes) which patients will record during a daily activity, two times per day, once in the morning and once in the evening during one week before clinical visit.
次要结局
- Improvement of the sitting time, as measured from baseline to 12 months of follow-up.(12 months)
- Euro Quality of Life-5 Dimension Health questionnaire, as measured from baseline to 12 months of follow-up.(12 months)
- Improvement of the sitting time, as measured from baseline to 1 month of follow-up.(1 month)
- Pain relief (visual analogic scale), as measured from baseline to 12 months of follow-up.(12 months)
- Pain relief (visual analogic scale), as measured from baseline to 6 months of follow-up.(6 months)
- Pain relief (visual analogic scale), as measured from baseline to 1 month of follow-up.(1 month)
- Improvement of the sitting time, as measured from baseline to 3 months of follow-up.(3 months)
- Use of pain treatment(1 month)
- Pain relief (visual analogic scale), as measured from baseline to 3 months of follow-up.(3 months)
- Euro Quality of Life-5 Dimension Health questionnaire, as measured from baseline to 6 months of follow-up(6 months)