Comparison of Inelastic and Elastic Lumbosacral Orthoses on Low Back Pain Prevention in Hospital Nurses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- The sick leave days due to low back pain
研究概览
简要总结
The main objective of this study is to investigate the efficacy of two different design characteristics of lumbar support for low back pain prevention in hospital nurses.
详细描述
Low back pain occurs frequently and is one of the most costly health problems affecting industry and society. Prevention of low back pain is important both for the individual patient and from an economic perspective. Therefore, there are many measures available that claim to reduce low back pain and its recurrence. The most commonly used preventive strategies are fitness exercises, lumbar supports, education on back mechanics and lifting techniques, and ergonomic adjustments. However, their efficacy is still uncertain. The main objective of this study is to investigate the efficacy of two different design characteristics of lumbar support for low back pain prevention in hospital nurses. Investigators hope that those two types of lumbar support will reduce the incidence of low back pain and sick leave days. In addition, Investigators hypothesize that there are some differences on outcome measures between those two types of lumbar support. Enrolled subjects will be randomly assigned to one of the following three groups. The first group will wear an inelastic lumbar support for 6 months. The second group will wear an elastic lumbar support for 6 months. The third group will receive no intervention. After the completion of 6-month intervention, a further 6 months fellow-up will be added.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 25 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female between 20 and 25 years of age
- •Subjects who have worked as a nurse less than two years and will continue working as a nurse no less than one year
- •Job contents including moving and lifting patients, long-time standing and frequent bending
- •Subjects who do not participate any other study concerning pain prevention currently and in the next year
排除标准
- •Subjects who are experiencing low back pain symptoms at the time of inquiry, regardless of acute or chronic, and seeking medical care currently
- •Subjects who have experienced 2 or more episodes (on 2 consecutive days) of low back pain symptoms in the 12 months before the inquiry
- •Subjects who are suffering from any other chronic pain disorders symptomatically
- •Subjects who have used a lumbar support during the last 6 months
- •Subjects with specific low back pain (like infection, tumors, osteoporosis, fracture, structural deformity, inflammatory disorder, radicular syndrome or cauda equina syndrome, spinal stenosis or spondylolysis)
- •Subjects who have had a spinal operation
- •Subjects who are suffering from chronic cardiac, respiratory, liver and kidney complaint symptomatically
- •Subjects who are suffering from diseases that might be aggravated by increased intra-abdominal pressure, like hernia
- •Subjects who are suffering from chronic gastrointestinal disorders symptomatically
- •Subjects who are pregnant, planning to have a baby in 1 year or less than 6 months after delivery
- •Subjects who are suffering from serious somatic disease and/or psychic disease
结局指标
主要结局
The sick leave days due to low back pain
时间窗: 12 months after initiation
The incidences of low back pain
时间窗: 12 months after initiation
次要结局
- Medical care utilization(12 months after initiation)
- Quality of life(12 months after initiation)
- Adverse Effects(12 months after initiation)
研究者
Hongbin Lu
Professor
Central South University