Effects of Health Education for Patients Received Minimally Invasive Lumbar Spinal Surgery
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change of Oswestry Disability Index
研究概览
简要总结
Lumbar degenerative disease surgery has been a routine clinical operation, and has good treatment effects. Although the patient's neurological symptoms improve after surgery, many patients still have postoperative muscle soreness. The postoperative rehabilitation intervention for the patients receiving traditional lumbar surgery has been confirmed to effectively improve pain and disability. However, in recent years, minimally invasive lumbar spinal surgery has gradually replaced traditional surgery, postoperative pain has been greatly reduced. Therefore, patients have the opportunity to receive early intervention in rehabilitation, but there is no standardization process for rehabilitation of minimally invasive lumbar spine surgery. Therefore, this study aims to establish a health education program for patients receiving minimally invasive lumbar spinal surgery, and conduct clinical trials to test its effectiveness.
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 (Care Provider)
入排标准
- 年龄范围
- 45 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 45 and 90 years old.
- •Low back pain has been persisting at least 3 months.
- •Clinical degeneration diagnosis supports the need of MI-TLIF.
- •Able to understand Chinese.
排除标准
- •Emergency surgery.
- •Unstable vital sign.
- •Any psychological, neurological, orthopedics, cardiopulmonary, and cancer history.
- •Had spinal surgery before.
- •Pregnancy.
研究组 & 干预措施
Education group
干预措施: Perioperative Rehabilitation (Behavioral)
Usual care group
结局指标
主要结局
Change of Oswestry Disability Index
时间窗: The day before operation day, and 1, 3, 6 months after surgery
This scale evaluates subject's physical function. The range is 0 to 1. Higher values represent a better outcome.
Change of Short Form 12 version 2
时间窗: The day before operation day, and 1, 3, 6 months after surgery
This scale evaluates subject's health-related quality of life. We will record the subscales: physical component summary (PCS) and mental component summary (MCS). Higher values represent a better outcome.
Change of Functional reach test
时间窗: The day before operation day, and 1, 3, 6 months after surgery
It is a dynamic measure of balance. A 100 cm yardstick will be horizontally set on the wall with the acromion height. The patient will be asked to make a fit and reach forward as far as possible without moving his/her feet. It will be measured twice and the better outcome will be recorded.
Change of Visual Analogue Scale
时间窗: The day before operation day, and 1, 3, 6 months after surgery
This scale evaluates subject's pain intensity. "0" indicates no pain and "10" indicates the worst possible pain.
Change of Timed Up and Go test
时间窗: The day before operation day, and 1, 3, 6 months after surgery
It was developed to measure subjects' balance and mobility. The patient starts with a sitting position, stands up, walks a 3-meter distance, turns, walks back, and sits down. He/She will be encouraged to finish it safely as soon as possible. A shorter time indicates better function.
Change of 15-m walk test
时间窗: The day before operation day, and 1, 3, 6 months after surgery
Gait speed shows good reliability and is valid to assess physical mobility. A 15-mile straight line will be mounted on a flat surface. The patient will be required to walk down the line at the maximal speed. He/She will be encouraged to finish it safely as soon as possible. A shorter time indicates better function.
Change of 30-second Chair Rise
时间窗: The day before operation day, and 1, 3, 6 months after surgery
It is used to evaluate the lower limb function and strength relating to the daily activities. The patient starts with a sitting position, and need to repeat stand-to-sit movements. He/She will be encouraged to move safely as soon as possible in 30 minutes. Higher number indicates better function.
次要结局
- Narcotic use during hospitalization(The duration between admission and discharge)
- Return-to-work status(up to 6 months after surgery)
- Adverse events(up to 6 months after surgery)
- Length of hospitalization(The duration between admission and discharge)