Diffusion tensor imaging for lumbar spine backache patients

Phase 1/2

Completed

• Conditions: Other disorders of the nervous system,

• Registration Number: CTRI/2019/11/021987
• Lead Sponsor: Kasturba Medical College

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-13
• Study Completion: 2020-04-17
• Last Update Posted: 2020-11-07

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
After Study Completion	After Study Completion

Trial Locations

Locations (1)

Kasturba Hospital, Manipal; 🇮🇳 Udupi, KARNATAKA, India

Kasturba Hospital, Manipal

🇮🇳Udupi, KARNATAKA, India

Kaushik Nayak

Principal investigator

9113933708

kaushiknayak1996@gmail.com