| CTRI Number |
CTRI/2025/04/084446 [Registered on: 09/04/2025] Trial Registered Prospectively |
| Last Modified On: |
18/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Ultrasound guided Transforaminal epidural injection for Pain relief in patients of Lower Back Pain |
|
Scientific Title of Study
|
Comparison between parasagittal oblique approach and axial approach of ultrasound guided technique in transforaminal epidural injection: A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jyotsna Punj |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Department of Anesthesiology, Pain Medicine and Critical Care, Room no 5016, Academic BLock, All India Institute of Medical Sciences, Ansari Nagar, South Delhi
South
DELHI
110029
India |
| Phone |
9810191116 |
| Fax |
|
| Email |
jyotsna_punj@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jyotsna Punj |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Department of Anesthesiology, Pain Medicine and Critical Care, Room no 5016, Academic BLock, All India Institute of Medical Sciences, Ansari Nagar, South Delhi
South
DELHI
110029
India |
| Phone |
9810191116 |
| Fax |
|
| Email |
jyotsna_punj@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Harsh Mittal |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Department of Anaesthesiology, Pain Medicine and Critical Care, AIIMS, Ansari Nagar, South Delhi
South
DELHI
110029
India |
| Phone |
9971293017 |
| Fax |
|
| Email |
hmittalyo@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology Pain Medicine and Critical Care AIIMS New Delhi |
|
|
Primary Sponsor
|
| Name |
Jyotsna Punj |
| Address |
Room no 5016, Academic Block, All India Institute of Medical Sciences, New Delhi-110029 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Department of Anaesthesiology Pain Medicine and Critical Care AIIMS New Delhi |
All India Institute of Medical Sciences, New Delhi-110029 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jyotsna Punj |
AIIMS, New Delhi |
Department of Anesthesiology, Pain Medicine and Critical Care, Room no 5016, Academic BLock, All India Institute of Medical Sciences, Ansari Nagar, South Delhi
South
DELHI |
9810191116
jyotsna_punj@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, AIIMS, Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G55||Nerve root and plexus compressionsin diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Axial in-plane Approach of Transforaminal Epidural Injection |
The ultrasound probe will be used to scan the midline of the vertebral column. After that the probe will be kept in the axial plane, and the needle will be advanced in an in-plane approach to give a transforaminal epidural infection. |
| Intervention |
Parasagittal Oblique out-of-plane Approach of Transforaminal Epidural Injection |
The ultrasound probe will be used to scan the midline of the vertebral column. After that the probe will be kept in the parasagittal plane, tilted 20-25 degrees medially, and the needle will be advanced in an out-of-plane approach to give a transforaminal epidural infection. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed case of unilateral lumbosacral radicular pain not involving more than 2 dermatomes at either levels of L3 L4 L5, ASA I and II, Pain lasting more than three months, NRS more than 5 after administrating medical management |
|
| ExclusionCriteria |
| Details |
patient with any known allergy to local anesthesia, pregnancy, neurological or psychiatric disease on concurrent medication, local site infection/sepsis/bacteremia, coagulation disorder, spinal tumors/spinal tuberculosis/spinal deformity, symptoms of severe nerve damage including motor paralysis/muscle atrophy/peripheral neuropathy/arterial vascular disease/malignancy/cauda equina syndrome |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To see dye spread pattern through both approaches |
immediately after intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To note the needle tip positioning |
immediately after completion of intervention |
| Time to Procedure (scanning & needling) |
immediately after completion of intervention |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
21/04/2025 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
|
Transforaminal Epidural Injection is used for pain relief in
patients of radicular lumbosacral pain under fluoroscopic guidance.(1)
Fluoroscopy has various limitations like requirement of specialized equipments,
technical staff and risk of radiation exposure. If the procedure can be done
under USG guidance, then it would reduce radiation exposure and cost of
procedure. USG guided Transforaminal
epidural injection has been tried in both axial and parasagittal oblique approach
with fluoroscopic or CT confirmation.(2)
Previously both techniques have not been compared with respect to dye spread.
Therefore this study aims to compare the dye spread pattern of the two approaches.
1. Patel K, Chopra P,
Martinez S, Upadhyayula S. Epidural Steroid Injections. In: StatPearls
[Internet]. Treasure Island (FL): StatPearls Publishing; 2024 [cited 2024 Nov
10]. Available from: http://www.ncbi.nlm.nih.gov/books/NBK470189/
2. Soni
P, Punj J. Ultrasound-Guided Lumbar Transforaminal Epidural Injection: A
Narrative Review. Asian Spine J. 2021 Apr;15(2):261–70.
|