跳至主要内容
临床试验/CTRI/2019/11/021987
CTRI/2019/11/021987已完成1/2 期

A diffusion tensor imaging study to compare normative fractional anisotropy value with patients suffering from lower back pain.

Kasturba Medical College1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2019年11月13日最近更新:
适应症

试验速览

阶段
1/2 期
状态
已完成
入组人数
64
试验地点
1
主要终点
The calculation of FA values will help the clinicians in early detection of the radiculopathy

研究概览

简要总结

Approval will be obtained from the institutional research committee, SOAHS and Institutional Ethical Committee, Kasturba Medical College. 40 patients will be with the age greater than 18 years will be included in the cross sectional prospective study after screening. Informed consent will be obtained from the patients. The scanning will be performed using Philips Achieva 1.5 Tesla MRI. Diffusion tensor imaging protocol will be used and raw data will be collected. The radiologist will assess the variation in the fractional anisotropy value. The data will be analyzed using SPSS statistical package for social science and descriptive data analysis is done using Independent sample T test or Mann Whitney U test

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 55.00 Year(s)(—)
性别
All

入选标准

  • •Inclusion criteria for individuals with back pain: The subject should be greater than 18 years and less than 55 years The subjects who are suffering from lower back pain Inclusion criteria for individual without back pain: The subjects with sciatica, changes in bladder and bowel functions, numbness in the leg or foot and decreased reflexes at the knee and ankle.

排除标准

  • •Exclusion criteria for individuals with back pain: The subjects who are contraindicated to MRI Exclusion criteria for the individual without back pain: The subjects who are contraindicated to MRI.

结局指标

主要结局

The calculation of FA values will help the clinicians in early detection of the radiculopathy

时间窗: The calculation of FA values will help the clinicians in early detection of the radiculopathy

次要结局

  • After Study Completion(After Study Completion)

研究者

申办方类型
Research institution

研究点 (1)

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