Minimally Invasive Cordotomy for Refractory Cancer Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Change in Pain Intensity using a 0-10 numeric rating scale
研究概览
简要总结
The goal of this clinical research study is to learn if a cordotomy reduces pain in patients with unmanageable cancer pain. A cordotomy is a procedure, guided by computed tomography (CT) scans, that is performed on the spinal cord and is designed to reduce pain transmission.
详细描述
Baseline Tests:
If you agree to take part in this study, you will have the following tests and procedures:
- You will have a physical exam.
- You will complete 2 questionnaires that ask about any symptoms and pain you may be having. It should take about 10 minutes to complete the questionnaires.
- You will have sensory testing. These are tests to measure your level of pain and feelings of hot and cold in the foot, palm of the hand, and the area where your pain is the worst.
Study Groups:
You will be assigned to 1 of 2 groups. You will have an equal chance of being in either group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Patients with one-sided, somatic pain due to tumor involvement below the shoulder level (C5 dermatome).
- •Patients with refractory cancer pain who are seen by the Supportive Care or Pain Medicine teams, and who either (1) are on appropriate opioid therapy at the time of consultation, or (2) who undergo an initial consultation and at least 2 clinical follow-up evaluations by these services.
- •Patients with a life expectancy greater than 1 month.
- •Patients must be 18 years old or older.
- •Patients must be able to read, speak and understand English or Spanish.
排除标准
- •Patients with significant pulmonary dysfunction, large intracranial metastases, or significant thrombocytopenia (platelet count refractory to transfusion).
结局指标
主要结局
Change in Pain Intensity using a 0-10 numeric rating scale
时间窗: Day 1 and Day 8
The response rate for both the cordotomy and control groups determined by the change in pain intensity between day 1 and day 8. Pain intensity assessed before and after cordotomy using a 0-10 numeric rating scale. Response rate defined as a 33% reduction in pain intensity with a 95% confidence interval, separately within each arm.
次要结局
未报告次要终点