| CTRI Number |
CTRI/2025/04/083770 [Registered on: 01/04/2025] Trial Registered Prospectively |
| Last Modified On: |
27/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Correlation between vitamin D level and outcomes of transforaminal epidural steroid injection in lumbar radiculopathy |
|
Scientific Title of Study
|
Correlation between vitamin D level and outcomes of transforaminal epidural steroid injection in lumbar radiculopathy: A Prospective observational study
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sanjay Kumar |
| Designation |
Professor |
| Affiliation |
Sanjay Gandhi Post Graduate Institute of Medical Sciences |
| Address |
Dept. of Anesthesiology Sanjay Gandhi Postgraduate Institute of medical Sciences Lucknow, India Lucknow
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
9452535221 |
| Fax |
|
| Email |
drsanjaygupta9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sanjay Kumar |
| Designation |
Professor |
| Affiliation |
Sanjay Gandhi Post Graduate Institute of Medical Sciences |
| Address |
Dept. of Anesthesiology Sanjay Gandhi Postgraduate Institute of medical Sciences Lucknow, India Lucknow
UTTAR PRADESH
226014
India |
| Phone |
9452535221 |
| Fax |
|
| Email |
drsanjaygupta9@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sanjay Kumar |
| Designation |
Professor |
| Affiliation |
Sanjay Gandhi Post Graduate Institute of Medical Sciences |
| Address |
Dept. of Anesthesiology Sanjay Gandhi Postgraduate Institute of medical Sciences Lucknow, India Lucknow
UTTAR PRADESH
226014
India |
| Phone |
9452535221 |
| Fax |
|
| Email |
drsanjaygupta9@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sanjay Gandhi Postgraduate Institute Of Medical Sciences
Lucknow
UTTAR PRADESH
226014
India |
|
|
Primary Sponsor
|
| Name |
Sanjay Gandhi Postgraduate Institute of medical Sciences |
| Address |
Sanjay Gandhi Postgraduate Institute of medical Sciences, Lucknow, UP India-226014 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Sanjay Kumar |
Department of Anaesthesiology |
Type 4/68, SGPGIMS, Lucknow- UTTAR PRADESH 226014
Lucknow
UTTAR PRADESH |
8765974045
drsanjaygupta9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Sgpgi, lucknow |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M511||Thoracic, thoracolumbar and lumbosacral intervertebral disc disorders with radiculopathy, |
|
|
Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing transforaminal epidural steroidal injection for radicular low back pain with single level lumbar disc herniation and no co-existing or pre-existing spine pathology. |
|
| ExclusionCriteria |
| Details |
Patients with negative consent, significant bleeding diathesis, systemic or local infections, sever degenerative changes, surgical posterior fusion, daily supplementation of vitamin D, history of renal stones or trauma. |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
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Primary Outcome
|
| Outcome |
TimePoints |
| NUMERICAL RATING SCALE , |
AT BASELINE, 2 WEEKS POST PROCEDURE, 4 WEEKS POST PROCEDURE, 3 MONTHS POST PROCEDURE |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| OSWESTRY DISABILITY INDEX FOR BACK PAIN |
AT BASELINE, 2 WEEKS POST PROCEDURE, 4 WEEKS POST PROCEDURE, 3 MONTHS POST PROCEDURE |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
08/04/2025 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
Aims and Objectives: •Primary Objective: To compare the analgesic effect of Transforaminal Epidural Steroid Injection in patients with and without Vitamin D deficiency. •Secondary Objective: To compare the change in Oswestry Disability Index (ODI) between pre and post procedure in the control and study groups •Study Design : A prospective observational study •Study Site : SGPGIMS •Study Duration : 2 year •Study Population : 80 patients Outcome Measures:•Severity of pain would be assessed by Numeric Rating Scale (NRS) at baseline, 2hr after intervention, 2 weeks, 1st month and 3rd month postoperatively either in follow up OPD or telephonically. Success of intervention would be defined as more than 50 % reduction in NRS from baseline values. •Oswestry Disability Index (ODI) would be calculated at baseline, 2 weeks, 1st month and 3rd month.
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