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临床试验/NCT07061067
NCT07061067招募中不适用

Affection of Symptoms Duration on Outcomes of Lumbar Spine Surgery

Kafrelsheikh University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年7月19日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
Disability assessment

研究概览

简要总结

This study aims to evaluate the affection of symptoms duration on outcomes of lumbar spine surgery.

详细描述

Lumbar spine surgery is a pivotal intervention for a variety of conditions affecting the lower back, such as degenerative disc disease, spinal stenosis, spondylolisthesis, and disc herniation.

The first line of treatment in lumbar spine is usually conservative. If conservative treatment fails to lead to an improvement in symptoms in 3 to 6 months, surgical treatment can be considered as an option for symptom relief. Invasive therapies are considered when neurogenic claudication is present with positive findings from diagnostic imaging. Surgery has been shown to provide better outcomes for at least 4 years in terms of disability and pain with a narrowing of the benefits over time compared with conservative treatment.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥18 years old.
  • Both sexes.
  • Patients undergoing lumbar spine surgery
  • Presenting symptoms include lumbar back pain, lumbar radiculopathy, neurogenic claudication, lower-extremity weakness, bowel or bladder symptoms, and duration of symptoms.

排除标准

  • Previous spinal surgery.
  • Vascular claudication.
  • Comorbid pathology affecting walking ability.
  • Severe comorbidities that may impact surgery outcomes (e.g., uncontrolled diabetes, cardiovascular disease).
  • Bony metastases.
  • Unfit for general anaesthesia.

结局指标

主要结局

Disability assessment

时间窗: 6 months postoperatively

Disability assessment will be done by the Oswestry Disability Index (ODI). ODI is a pain-related disability score ranging from 0 (no impairment) to 100 (bedbound).

次要结局

  • Degree of patient satisfaction(6 months postoperatively)
  • Degree of pain(6 months postoperatively)
  • Musculoskeletal conditions(6 months postoperatively)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ayman Mohamed Basha

Lecturer of Neurosurgery, Faculty of Medicine, KafrElsheikh University, KafrElsheikh, Egypt

Kafrelsheikh University

研究点 (1)

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