The Comparative Study for Treatment Outcomes of Osteoporotic Compression Fracture Without Neurologic Injury Using Rigid Brace, Soft Brace, and no Brace
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- Oswestry Disability Index (ODI) at 12 Weeks
研究概览
简要总结
The treatment outcomes in the treatment without brace would be non-inferior to those in use of rigid or soft brace.
详细描述
Bracing has been considered as a landmark step in conservative management for osteoporotic compression fractures. However, no prospective, randomized, and controlled clinical trials are available to document for the efficacy of wearing of the rigid or soft brace for the management of osteoporotic compression fracture. Therefore, the current trial was therefore designed to compare the outcome for improvement of disability and pain in patients with osteoporotic compression fracture using rigid, soft, or no brace.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •the presence of acute back pain caused by a single level vertebral fracture within 3 days of minor trauma such as fall from height,
- •compression fracture between T 7 and L3 including injuries of only anterior compartment of vertebral body without neurologic deficit.
排除标准
- •the presence of more than two recent vertebral fractures,
- •pathologic malignant compression fractures,
- •neurologic complications,
- •a history of previous injury or surgery to the fractured level,
- •inability to complete the questionnaires about pain and disability.
研究组 & 干预措施
No brace group
Patients in the no brace treatment group were allowed to ambulate without any braces as long as it would be tolerable.
干预措施: No brace treatment (Device)
Rigid brace group
Patients in the rigid brace immobilization group were strictly maintained on bed rest until fitted a thoraco-lumbo-sacral orthosis. Brace is required to be worn at all times except when lying. All patients were instructed to wear the rigid brace for a total of 8 weeks.
干预措施: Rigid brace (Device)
Soft brace group
Because soft back brace was a custom-made, it began to be worn when enrollment for the study. Brace is required to be worn at all times except when lying. All patients were instructed to wear the soft brace for a total of 8 weeks.
干预措施: Soft brace (Device)
结局指标
主要结局
Oswestry Disability Index (ODI) at 12 Weeks
时间窗: 12 weeks after injury
The primary outcome was the score for Oswestry Disability Index (ODI) at 12 weeks after compression fracture. The ODI is a self-reported questionnaire measuring back-specific function including pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and traveling. The questionnaire consists of 10 items each with 6 response levels. Each item is scored from 0 to 5, and the total score is converted to a 0 to 100 scale (zero is equated with no disability and 100 is the maximum disability possible).
次要结局
- General Health Status(at the initial enrollment and 12 weeks after compression fracture)
- Oswestry Disability Index (ODI)(at 2 weeks, 6 weeks, and 12 weeks after compression fracture.)
- the Progression of Body Compression Ratio Over All Follow-up Assessments(2 weeks, 6 weeks, and 12 weeks after compression fracture)
- Visual Analog Pain Scale (VAS) for Back Pain(2 weeks, 6 weeks, 12 weeks after injury)
研究者
Jin S. Yeom
professor
Seoul National University Hospital