| CTRI Number |
CTRI/2019/11/021987 [Registered on: 13/11/2019] Trial Registered Prospectively |
| Last Modified On: |
11/07/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Diffusion tensor imaging for lumbar spine backache patients |
|
Scientific Title of Study
|
A diffusion tensor imaging study to compare normative fractional anisotropy value with patients suffering from lower back pain. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kaushik nayak |
| Designation |
student |
| Affiliation |
School of Allied Health Sciences |
| Address |
Dept.of Medical Imaging Technology , School Of Allied Health Sciences, Manipal.
Udupi
Karnataka
India
Dept.of Medical Imaging Technology , School Of Allied Health Sciences, Manipal.
Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
9113933708 |
| Fax |
|
| Email |
kaushiknayak1996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lakshmikanth H K |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College |
| Address |
Dept.of Radiodiagnosis and Imaging KMC Manipal.
Udupi
Karnataka
India
Dept.of Radiodiagnosis and Imaging KMC Manipal.
Udupi
Karnataka
India
Udupi
KARNATAKA
576104
India |
| Phone |
9113933708 |
| Fax |
|
| Email |
hkkanha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kaushik nayak |
| Designation |
Student |
| Affiliation |
School of Allied Health Sciences |
| Address |
Dept.of Medical Imaging Technology , School Of Allied Health Sciences,Manipal.
Udupi
Karnataka
India
Udupi
KARNATAKA
576104
India |
| Phone |
9113933708 |
| Fax |
|
| Email |
kaushiknayak1996@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College |
| Address |
Room No 13 Shirdi Sai Baba Cancer Block
Kasturba Medical College
Manipal 576104
Karnataka |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Kaushik Nayak |
Kasturba Hospital, Manipal |
Room No. 13, Dept. of
Radio-diagnosis and
Imaging, Shirdi Sai Baba cancer block
block, Manipal ,udupi,
karnataka.
Udupi
KARNATAKA
Udupi
KARNATAKA |
9113933708
kaushiknayak1996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G89-G99||Other disorders of the nervous system, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
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.
|
|
| ExclusionCriteria |
| Details |
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
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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
|
| Outcome |
TimePoints |
| After Study Completion |
After Study Completion |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
13/11/2019 |
| Date of Study Completion (India) |
17/04/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
17/04/2020 |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
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 |