The Influence of the Timing of Postoperative Rehabilitation Intervention on the Clinical
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Li Xiang
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Oswestry Disability Index (ODI) Score
研究概览
简要总结
This study focuses on the impact of the timing of postoperative rehabilitation intervention on the clinical efficacy of unilateral biportal endoscopic spine surgery in the treatment of lumbar disc herniation. The main objective is to explore this impact and provide high-quality evidence-based medical evidence for making reasonable clinical decisions.
详细描述
This study is a prospective randomized controlled trial on the impact of the timing of postoperative rehabilitation intervention on the clinical efficacy of unilateral biportal endoscopic spine surgery in the treatment of lumbar disc herniation. The main purpose is to explore this impact and provide high-quality evidence-based medical evidence for making reasonable clinical decisions. According to the inclusion and exclusion criteria formulated in this study, 72 patients who underwent UBE surgery for lumbar disc herniation were recruited in our hospital and randomly assigned to the early rehabilitation intervention group (referred to as the early rehabilitation group, with rehabilitation intervention starting 2 weeks after surgery) or the late rehabilitation intervention group (referred to as the late rehabilitation group, with rehabilitation intervention starting 6 weeks after surgery) after surgery. The clinical and subjective (questionnaire) data of the subjects before surgery, after surgery and during the follow-up process (up to 12 months after surgery) were collected to compare the differences in clinical efficacy between early and late postoperative rehabilitation intervention in patients with lumbar disc herniation treated by UBE.
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
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 19 and 65 years.
- •Diagnosed with lumbar disc herniation by imaging and scheduled for unilateral biportal endoscopic (UBE) surgery.
- •Presenting with radicular pain in the lower extremity, with a history of less than 1 year.
- •Able to understand Chinese and complete questionnaires independently.
- •Physically capable of participating in exercise rehabilitation.
- •Willing to participate and provide written informed consent.
排除标准
- •Aged under 18 or over 65 years.
- •Combined with other spinal pathologies (e.g., ankylosing spondylitis, rheumatoid arthritis, spinal tumor, spinal fracture, cauda equina syndrome).
- •Diagnosis of neurological disorders (e.g., multiple sclerosis, Parkinson's disease).
- •Presence of uncontrolled cardiovascular, respiratory, or peripheral vascular diseases.
- •History of severe psychiatric disorders (e.g., schizophrenia).
- •Previous history of spinal surgery.
- •Pregnancy or lactation.
- •Inability to understand or comply with the study procedures.
结局指标
主要结局
Oswestry Disability Index (ODI) Score
时间窗: Change from Baseline to 12 months postoperatively
The Oswestry Disability Index (ODI) is a widely validated and disease-specific patient-reported outcome measure for assessing functional status in individuals with low back pain. The questionnaire consists of 10 items addressing pain intensity, personal care, lifting, walking, sitting, standing, sleeping, social life, traveling, and employment/homemaking. Each item is scored from 0 to 5, and the total score is converted to a percentage (0-100%), with higher scores indicating greater disability. The ODI score at 12 months postoperatively will be used as the primary endpoint to evaluate the long-term effect of rehabilitation timing.
次要结局
未报告次要终点