| CTRI Number |
CTRI/2020/10/028426 [Registered on: 15/10/2020] Trial Registered Prospectively |
| Last Modified On: |
14/10/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
comparative study of transforaminal versus interlaminar epidural steroid injection for pain management in lumbar prolapsed intervertibral discs at sms hospital |
|
Scientific Title of Study
|
comparative study of transforaminal versus interlaminar epidural steroid injection for pain management in lumbar prolapsed intervertibral discs at sms hospital during 2019-2021 comparative interventional study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr PS Lamba |
| Designation |
senior professor |
| Affiliation |
Sms medical college jaipur |
| Address |
SMS Hospital Ot 2
jaipur
rajasthan
Jaipur
RAJASTHAN
302004
India |
| Phone |
|
| Fax |
|
| Email |
drpslamba@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr PS Lamba |
| Designation |
senior professor |
| Affiliation |
Sms medical college jaipur |
| Address |
SMS Hospital
jaipur
rajasthan
Jaipur
RAJASTHAN
302004
India |
| Phone |
|
| Fax |
|
| Email |
drpslamba@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr PS Lamba |
| Designation |
senior professor |
| Affiliation |
Sms medical college jaipur |
| Address |
SMS Hospital
jaipur
rajasthan
Jaipur
RAJASTHAN
302004
India |
| Phone |
|
| Fax |
|
| Email |
drpslamba@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesiology sms medical hospital jaipur rajasthan |
|
|
Primary Sponsor
|
| Name |
department of anaesthesiology |
| Address |
sms hospital jaipur rajasthan |
| Type of Sponsor |
Government 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 |
| dr anita chouhan |
SMS medical college and hospital |
Department of anaesthesiology Pain clinic first floor dhanwantri building sms hosptal jaipur rajathan
Jaipur
RAJASTHAN |
9887466464
chouhananitadl@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| sms medical college jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R00-R99||Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
interlaminar approach |
Group A will receive interlaminar epidural with inj 2%xylocaine plus methylprednisolone 80mg and observe for 6 month |
| Comparator Agent |
Transforaminal epidural approach |
Group B will receive transforaminal epidural with inj 2%xylocaine plus methylprednisolone 40mg and observe for 6 month |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
disc herniation diagnosed by mri
failure to conservative treatment
asa grade 1 to 2
patients willing to give consent
|
|
| ExclusionCriteria |
| Details |
sequestrated herniation on mri
motor deficit
cauda equina syndrome
allergic to local anaesthetics and steroids
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to see improvement in Japanese orthopedic association score |
from baseline to 6 month after injection |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| side effects of injection |
6 month |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
15/10/2020 |
| 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="20"
Months="11"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
AIM: To compare Transforaminal versus Interlaminar epidural steroid injection for pain management in lumbar intervertebral disc prolapsed cases. OBJECTIVES: Primary objective-To see improvement in JOA score from baseline to 1 and at 6 month Secondary objective- To see the side effects, if any . |