Analysis of the Impact in the Quality of Life of Patients With Pain Secondary to Osteoporotic Vertebral Fractures Receiving Conservative Treatment Versus Percutaneous Vertebroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Impact into quality of life with the Qualeffo-41 test
研究概览
简要总结
The purpose of this study is to determine whether percutaneous vertebroplasty is able to improve long-term quality of life in patients with pain secondary to osteoporotic vertebral fractures, compared to conventional medical treatment.
详细描述
Osteoporotic vertebral fractures are associated with pain and severe disability in a high percentage of patients. Vertebroplasty has become the treatment of choice to alleviate pain in those patients who have not responded to medical treatment.Although several case series and non-randomized studies have shown the effectiveness of vertebroplasty in alleviating pain secondary to osteoporotic vertebral fractures, the long-term effect of this treatment has not been compared to standard medical treatment in a randomized study.
In our study we have analyzed the long-term effect of vertebroplasty in terms of quality of life in patients with painful osteoporotic vertebral fractures, randomizing them into two arms: percutaneous vertebroplasty or conventional medical treatment.
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
- 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
- •Painful (pain intensity of at least 4 on a scale from 0 to 10) osteoporotic vertebral fracture between levels T4 and L5
- •Fragility; i.e. fracture not in relation with significant trauma
- •Recent fracture, pain beginning not earlier than 1 year before inclusion
排除标准
- •No vertebral edema on STIR MR images
- •Uncorrectable bleeding diatheses
- •Active infection
- •Substantial retropulsion of bony fragments
- •Non-osteoporotic fracture
- •Concomitant neoplasm
结局指标
主要结局
Impact into quality of life with the Qualeffo-41 test
时间窗: Baseline, 2 weeks, 2 months, 6 months and 1 year
次要结局
- Analyze pain alleviation with the Analog Visual Scale(Baseline, 2 weeks, 2 months, 6 months and 1 year)
研究者
JORDI BLASCO ANDALUZ
MD, PhD
Hospital Clinic of Barcelona