Effectiveness of Spinal Cord Stimulation as Therapy for Chemotherapy-Induced Peripheral Neuropathy: A Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Permanent Spinal Cord Stimulator Implantation
研究概览
简要总结
This is an observational based pilot study evaluating the use of spinal cord stimulators for the treatment of chemotherapy induced peripheral neuropathy will lead to an increase in quality of life and decrease in pain.
详细描述
Cancer treatment, for many patients, results in painful side effects. As evidence mounts demonstrating the risks associated with long term opioid therapy, non-opioid modalities need to be developed. Spinal cord stimulators are implanted devices that modulate the pain signaling system in the spinal cord. This research hopes to determine if the use of a spinal cord stimulator in patients with chemotherapy induced peripheral neuropathy will lead to an increase in quality of life and decrease in pain.The primary endpoints will be the number of patients who undergo permanent implantation. The endpoints will measure pain with the Brief Pain Inventory Short Form visual analog scale. The sleep quality will be measured using the Pittsburgh Sleep Quality Assessment.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The patient has persistent, severe peripheral neuropathy secondary to chemotherapy
排除标准
- •Refusal to undergo a spinal cord stimulator procedure
结局指标
主要结局
Permanent Spinal Cord Stimulator Implantation
时间窗: 2 years
To determine the total number of patients who undergo permanent spinal cord stimulator implantation.
次要结局
- Subjective Quality of Life Assessment: Pittsburgh Sleep Quality Assessment(2 years)
- Subjective Pain Assessment: Brief Pain Inventory-Short Form(2 years)