NCT02902250已完成不适用
The Comparative Study About the Effect of Vertebral Body Decompression Procedure and Conservative Treatment for Benign Vertebral Compression Fracture - Prospective Randomized Control Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Visual Analog Pain Scale
研究概览
简要总结
The purpose of this study is to compare the treatment efficacy between vertebral body decompression procedure and conservative treatment with non-inferiority design
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •osteoporotic vertebral compression fracture
排除标准
- •malignancy or inflammatory disease
- •severe pain in other joints
- •coagulopathy
- •an inappropriate person considered by investigator
研究组 & 干预措施
Decompression
Experimental
bone marrow decompression at fractured vertebral body
干预措施: Decompression (Procedure)
Conservative Treatment
Active Comparator
Conservative Treatment for compression fracture
干预措施: Conservative Treatment (Procedure)
结局指标
主要结局
Visual Analog Pain Scale
时间窗: until 3 months after procedure
Pain status
次要结局
- Oswestry Disability Index(until 3 months after procedure)
- EQ5D-5L(until 3 months after procedure)
- Leed Dyspepsia Questionnaire(until 3 months after procedure)
- Radiographic outcome(until 3 months after procedure)
研究者
Jin S. Yeom
professor
Seoul National University Hospital
研究点 (1)
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