NCT03888963Unknown不适用
for Patients With Fibrocystic Disease of the Breast, Does Pulsed Radiofrequency on Thoracic Paravertebral Nerve Reduce Pain Severity
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- the changes in pain intensity measured by VAS pain score
研究概览
简要总结
The investigators will evaluate the analgesic efficacy of pulsed radiofrequency on the thoracic paravertebral nerves for patients with chronic mastalgia of fibrocystic disease of the breast
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 60 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •patients with chronic mastalgia due to fibrocystic disease of the breast
- •the pain duration maintained for more than 1 year
- •the pain intensity is more than 5 on VAS pain score
排除标准
- •coagulopathy
- •infection at the site of the procedure
研究组 & 干预措施
PRF
Experimental
干预措施: PRF (Procedure)
SHAM
Sham Comparator
干预措施: SHAM (Procedure)
结局指标
主要结局
the changes in pain intensity measured by VAS pain score
时间窗: patients will be evaluated at 3 months postoperatively
VAS pain score, is a scale for pain measurements scored from 0 to 10 in which 0 = no pain and 10 = the worst imaginable pain
次要结局
未报告次要终点
研究者
Diab Fuad Hetta
Principle investigator
Assiut University
研究点 (2)
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