| CTRI Number |
CTRI/2024/05/066682 [Registered on: 02/05/2024] Trial Registered Prospectively |
| Last Modified On: |
22/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
MRI findings in patients with low back pain. |
|
Scientific Title of Study
|
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 |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vipul Agarwal |
| Designation |
Fellow in Spine Surgery |
| Affiliation |
Datta Meghe Institute Of Higher Education And Research |
| Address |
Department of Orthopaedics
DMIHER,Sawangi(Meghe), Wardha
Wardha
MAHARASHTRA
442107
India |
| Phone |
9616339510 |
| Fax |
|
| Email |
drvipulmarkasiya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ratnakar Ambade |
| Designation |
Professor and Head of Department |
| Affiliation |
Datta Meghe Institute Of Higher Education and Research |
| Address |
Department of Orthopaedics
DMIHER,Sawangi(Meghe), Wardha
Wardha
MAHARASHTRA
442107
India |
| Phone |
9823033511 |
| Fax |
|
| Email |
drambade@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ratnakar Ambade |
| Designation |
Professor and Head of Department |
| Affiliation |
Datta Meghe Institute Of Higher Education and Research |
| Address |
Department of Orthopaedics
DMIHER,Sawangi(Meghe), Wardha
Wardha
MAHARASHTRA
442107
India |
| Phone |
9823033511 |
| Fax |
|
| Email |
drambade@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute Of Higher Education and Research ,Sawangi,Meghe, Wardha, Maharashtra,442001, India |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
Sawangi,Meghe, Wardha,Maharashtra,442001,India |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Vipul Agarwal |
Jawahar Lal Nehru MedicalColege |
Department Of Orthopaedics
Shalinitai Meghe Superspeciality Building, Sawangi
Wardha
MAHARASHTRA |
9616339510
drvipulmarkasiya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Datta Meghe Institute of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M498||Spondylopathy in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NA |
| Comparator Agent |
NIL |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
-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.
|
|
| ExclusionCriteria |
| Details |
-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. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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. |
A patients are assessed in single time |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 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. |
|
|
Target Sample Size
|
Total Sample Size="250"
Sample Size from India="250"
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)
|
07/07/2024 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
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. |