Prospective Evaluation of Effectiveness and Safety of Closed-Loop Spinal Cord Stimulation in Treating Patients With Chronic Pelvic Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change in Pain Intensity
研究概览
简要总结
Spinal cord stimulation (SCS) is an effective treatment for patients with chronic pelvic pain. The investigators will evaluate how safe and effective closed-loop spinal cord stimulation is in treating these patients; closed-loop spinal cord stimulation is a more novel method in delivering spinal cord stimulation that controls energy output of the device based on real-time feedback on how the device is stimulating the spinal cord.
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
- •The investigators will include all adult patients (18 or older) with pelvic pain more than 6 months that has not responded to conservative medical management
排除标准
- •Major untreated medical comorbidities (uncontrolled diabetes mellitus, severe obesity, uncontrolled cardiopulmonary disease, etc.)
- •Secondary causes of pelvic pain that can be treated with appropriate medical or surgical interventions
- •Major untreated psychological comorbidities
- •Anatomical challeneges to place spinal cord stimulator
- •Ongoing legal or disability claims
研究组 & 干预措施
Treatment
Patient will go through trial of spinal cord stimulator. If trial results in >50% reduction in pain, they will receive implantable spinal cord stimulator
干预措施: ECAP (Evoked Compound Action Potential)-controlled Closed-Loop Spinal Cord Stimulation (Device)
结局指标
主要结局
Change in Pain Intensity
时间窗: Baseline, 3-month, 6-month and 12-month
Numerical Rating Scale (0-10; higher score is worse)
次要结局
- Patient Global Impression Change(Baseline, 3-month, 6-month and 12-month)
- Change in Pain Catastrophizing Scale(Baseline, 3-month, 6-month and 12-month)
- Change in sleep quality(Baseline, 3-month, 6-month and 12-month)
- Change in Disability(Baseline, 3-month, 6-month and 12-month)
- Change in Quality of Life(Baseline, 3-month, 6-month and 12-month)
- Change in Social Functioning(Baseline, 3-month, 6-month and 12-month)
研究者
Vafi Salmasi
Assistant Professor
Stanford University