跳至主要内容
临床试验/CTRI/2024/05/066682
CTRI/2024/05/066682尚未招募不适用

To assess the reliability and clinical significance of nerve root sedimentation sign and its correlation with dural sac cross-section area as related to lumbar canal stenosis

Datta Meghe Institute of Higher Education and Research1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2024年7月7日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
250
试验地点
1
主要终点
All those patients with severe low back pain with radiculopathy and claudication will show positive nerve root sedimentation sign on axial sections of T2W MRI of lumbar spine in correlation with decreased dural sac cross section area.

研究概览

简要总结

This study is done to validate the positive correlation between nerve root sedimentation sign and dural sac cross section area on MRI of lumbar spine in all those patients of more than 18 years of age with low back pain and radiculopathy and claudication. This study is done to rectify the knowledge gap by analysing the gray area bwtween positive sediment sign in patients of severe lumbar canal stenosis and negative sediment sign in those patients having the symptoms.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 85.00 Year(s)(—)
性别
All

入选标准

  • All the patients with low back pain and/or leg pain (duration more than 12 weeks) -Age above 18 years.
  • Patients willing to give written informed consent.

排除标准

  • Congenital spinal anomalies, Osteomyelitis, Spinal trauma, Compression fracture, evidence of lumbar or sacral tumours, diffuse bone metastasis or any previous lumbar spine surgery, prior spinal intervention will be excluded from the study.

结局指标

主要结局

All those patients with severe low back pain with radiculopathy and claudication will show positive nerve root sedimentation sign on axial sections of T2W MRI of lumbar spine in correlation with decreased dural sac cross section area.

时间窗: A patients are assessed in single time

次要结局

  • Correlation between nerve root sedimentation sign and other clinical measures like- visual analogue scaling (VAS)score and Oswestry Disabilty Index (ODI)(Patients are assesessed in single time point after enrolling in the study.)

研究者

发起方
Datta Meghe Institute of Higher Education and Research
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Vipul Agarwal

Datta Meghe Institute Of Higher Education And Research

研究点 (1)

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