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临床试验/NCT05791422
NCT05791422已完成不适用

Improvement of Low Back Pain After Surgical Decompression in Patients with Degenerative Lumbar Spinal Canal Stenosis

Assiut University1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2023年3月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
55
试验地点
1
主要终点
Changes in VAS score for low back pain following decompression surgery and in the follow up visits .

研究概览

简要总结

Degenerative lumbar spine disease is a leading cause of disability in the world; it encompasses conditions such as spondylolisthesis, disc degeneration, and lumbar spinal stenosis. Those conditions present with a variety of clinical symptoms, including lower extremity pain, weakness, and low back pain (LBP) of varying levels of severity and in severe cases urine and stool incontinence may result.

详细描述

Degenerative lumbar spine disease is a common indication for lumbar decompression surgery, especially in elderly patients. Moreover, Clinical studies prove that decompression is superior to conservative treatment with more favorable outcomes .

Surgical options for decompressing the lumbar spine vary from minimally invasive disc decompression to open laminectomy and foraminotomy.

The surgery aims to improve the quality of life in appropriately selected patients , in the form of improvement of walking distance, lower limbs pain, and other symptoms of spinal compression.

Few papers assessed LBP improvement after lumbar decompression surgery . The common practice that patients with degenerative canal stenosis and low back pain should undergo fusion surgery is not evidence based.

In this study the investigators aim to assess the improvement of clinical symptoms, especially low back pain and lower limbs pain in patients with degenerative lumbar spine disease after undergoing lumbar decompression surgery.

研究设计

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

入排标准

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

入选标准

  • •Patients with degenerative lumbar spine disease admitted to Assiut University Hospitals, Department of Orthopaedic and Trauma Surgery between March 2023 and March 2024, to whom lumbar decompression surgery is indicated regardless of age or neurological symptoms.
  • •Patients with grade one spondylolisthesis without evident instability can be added.

排除标准

  • •Patients who are not available for follow up
  • •Patients who refuse to participate in the study
  • •Patients with evidence of instability
  • •Previously operated patients on the same or adjacent segment.

结局指标

主要结局

Changes in VAS score for low back pain following decompression surgery and in the follow up visits .

时间窗: 1 year post operative

The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."

次要结局

  • Changes in ODI following decompression surgery and in the follow up visits.(1 year post operative)
  • Changes in EQ 5D 5l following decompression surgery and in the follow up visits.(1 year post operative)

研究者

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

Mahmoud Ahmed Fayek Amin

Principle Investigator

Assiut University

研究点 (1)

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