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CTRI Number  CTRI/2024/09/073733 [Registered on: 10/09/2024] Trial Registered Prospectively
Last Modified On: 10/09/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Using Advanced MRI to Detect Early Spinal Changes in People with Low Back Conditions 
Scientific Title of Study   Role of Diffusion Kurtosis Magnetic Resonance Imaging in Evaluation of Microstructural Changes in Degenerative Thoracolumbar Spine 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Neil Abraham Barnes  
Designation  PhD Research Scholar  
Affiliation  Manipal College Of health profession, Manipal Academy of Higher Education, Manipal  
Address  Department of Medical imaging Technology, Manipal College of Health professions, Manipal Academy of Higher Education, Manipal-576104

Udupi
KARNATAKA
576104
India 
Phone  9591016898  
Fax    
Email  neil.mchpmpl2023@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Winniecia Dkhar  
Designation  Associate Professor and Head  
Affiliation  Manipal College Of health profession, Manipal Academy of Higher Education, Manipal  
Address  Department of Medical imaging Technology, Manipal College of Health professions, Manipal Academy of Higher Education, Manipal-576104

Udupi
KARNATAKA
576104
India 
Phone  8095372184  
Fax    
Email  winniecia.dkhar@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Winniecia Dkhar  
Designation  Associate Professor and Head  
Affiliation  Manipal College Of health profession, Manipal Academy of Higher Education, Manipal  
Address  Department of Medical imaging Technology, Manipal College of Health professions, Manipal Academy of Higher Education, Manipal-576104

Udupi
KARNATAKA
576104
India 
Phone  8095372184  
Fax    
Email  winniecia.dkhar@manipal.edu  
 
Source of Monetary or Material Support  
Kasturba Medical College and Hospital, Manipal Academy of Higher Education, NManipal, Udupi, Karnataka-576104 
 
Primary Sponsor  
Name  KMC Manipal 
Address  Kasturba Medical College and Hospital, Manipal Academy of Higher Education, NManipal, Udupi, Karnataka-576104 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rajagopal K V   Kasturba Hospital   Department of Radiodiagnosis and imaging Room Number 3 Kasturba Medical College and Hospital, Manipal Academy of Higher Education, NManipal, Udupi, Karnataka-576104
Udupi
KARNATAKA 		 9448158901

rajagopal.kv@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KasturbaMedicalCollegeandKasturbaHospitalInstitutionalEthicsCommitte  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M513||Other thoracic, thoracolumbar andlumbosacral intervertebral disc degeneration,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Inclusion Criteria for Case:- The study will enroll adult participants aged ranging from 30-70 years. Patients referred for MRI scans of lumbar spine.

Inclusion Criteria for Control:-The study will enroll adult participants aged 30-70 years. Patients referred for lumbar spine MRI scans.
Conventional MRI scan images (T1&T2) will be evaluated and if only no abnormalities or no spinal disorder are noted, then DKI sequences will be considered as control for the study.
 
 
ExclusionCriteria 
Details  Patients with tumor or fracture in the spine region. History of spine surgery. Patients with MR unsafe body implants. Claustrophobic patients. Patients who are pregnant.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The primary outcome of this objective is to establish specific Diffusion Kurtosis Imaging (DKI) parameters within the intervertebral disc space, spinal cord, and spinal nerve roots that can reliably differentiate between healthy and degenerative thoracolumbar spine tissues, potentially enabling early detection, improved diagnosis, and more informed treatment planning for degenerative spine conditions.  At the time of scan  
 
Secondary Outcome  
Outcome  TimePoints 
The outcome of this objective is to determine the extent to which metabolic disorders such as obesity, hypertension, type II diabetes mellitus, and thyroid dysfunction are associated with changes in Diffusion Kurtosis Imaging (DKI) parameters in the thoracolumbar degenerative spine, potentially identifying metabolic factors that influence the progression or severity of spinal degeneration.  At the time of scan  
 
Target Sample Size   Total Sample Size="133"
Sample Size from India="133" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   23/09/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
The study aims to evaluate the role of diffusion kurtosis imaging in the early diagnosis of degenerative changes in the thoracolumbar spine. The study focuses on assessing the quantitative analysis of the MRI advance Sequence of  DKI parameters Mean Kurtosis, Axial Kurtosis, Radial Kurtosis, Mean Diffusivity, Axial Diffusivity, Radial Diffusivity, and Fractional Anisotropy in the intervertebral disc space, spinal cord, existing spinal nerve root of the thoracolumbar spine for screening of the degenerative spine. Approval for this cross-sectional study is obtained from the Institutional Research Committee, MCHP, and the Institutional Ethics Committee, Kasturba Hospital, Manipal, followed by the Institutional Protocol Approval Committee (IPAC) for topic registration. Clinical Trial Registry - India (CTRI) registration will also be completed. The study will recruit adult participants aged 30-70 years, referred for MRI scans of the lumbar spine. Inclusion criteria for cases include patients with degenerative spine conditions and lower back pain, while controls will have normal lumbar spine MRI scans. Exclusion criteria include spinal tumors, fractures, previous spine surgery, MR-unsafe implants, claustrophobia, or pregnancy. Detailed demographic information and a medical history, including metabolic diseases and medication use, will be collected, along with pain assessment using the Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2). DKI images will be processed using UIH software, with DKI parameters measured through elliptic regions of interest (ROIs) in the thoracolumbar spine. This data then will be statistically calculated.  Outcome measures will include DKI parameters (MK, RK, AK, FA, MD, RD, AD, KA) of both degenerative and healthy thoracolumbar spines, potentially serving as biomarkers for diagnosing degenerative spine conditions.
 
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