The Influence of Vertebral Mobility on Low Back Pain in Patients With Acute Osteoporotic Vertebral Fractures
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Relationship between dynamic mobility of acute vertebral fracture body and low back pain
研究概览
简要总结
Many patients with acute osteoporotic vertebral fracture (acute OVFs) admitted because of low back pain. But there are only part of patients with acute OVFs, because some patients do not have low back pain although OVFs occurred.
详细描述
Many patients of acute OVFs present with low back pain. While there are also many patients without low back pain even if acute OVFs occurred. The mechanism of low back pain after acute OVFs is well unknown. We set up a hypothesis that low back pain results from vertebral body mobility, which refers to a change of vertebral height or configuration with changes in body positioning. The main objective of this study is to reveal the relationship between vertebral body mobility and low back pain.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 45 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with acute osteoporosis fractures
排除标准
- •Patients without acute osteoporosis fractures (metastasis, infection, deformity,etc)
结局指标
主要结局
Relationship between dynamic mobility of acute vertebral fracture body and low back pain
时间窗: Up to 36 months
The investigators plan to analyze 300 patients who presented with acute back pain and were diagnosed as having acute OVFs on MRI. All radiographs were taken at the initial visit. Fracture mobility was determined by comparing cross-table supine lateral radiographs with sitting lateral radiographs (dynamic radiography). Mobility was considered present when a measurable change in vertebral body height occurred between supine and sitting radiographs.We also evaluate low back pain using visual analog scale (VAS) score. Then the patients undergo external fixation using Gips. After Gips fixation, dynamic radiography was performed again to evaluate reduction of dynamic mobility of the OVF body. VAS score was also evaluated after external fixation. We investigate patients' background such as age, sex, bone mineral density, etc. We performed statical analyses to determine the factors which related to low back pain after acute OVFs, especially fracture mobility.
次要结局
未报告次要终点
研究者
Toshihiko Kono
Head of Hospital
Tomidahama Hospital