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CTRI Number  CTRI/2024/04/066004 [Registered on: 19/04/2024] Trial Registered Prospectively
Last Modified On: 19/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Factors affecting pain relief after transforaminal epidural steroid.  
Scientific Title of Study   Predictive factors for treatment success of transforaminal epidural steroid injection in lumbosacral disc herniation induced chronic pain. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Preeti Rustagi  
Designation  Associate professor  
Affiliation  Lokmanya Tilak Municipal General Hospital Sion  
Address  Department of Anesthesia 4th floor College building Lokmanya Tilak Municipal Medical College and General Hospital Sion

Mumbai
MAHARASHTRA
400022
India 
Phone  9769215359  
Fax    
Email  drpreetirustagi@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Anshuka Sontakke 
Designation  Junior Resident  
Affiliation  Lokmanya Tilak Municipal General Hospital Sion  
Address  Lokmanya Tilak Municipal General Hospital Sion

Mumbai
MAHARASHTRA
400022
India 
Phone  8421305267  
Fax    
Email  anshusontakke@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Preeti Rustagi  
Designation  Associate professor  
Affiliation  Lokmanya Tilak Municipal General Hospital Sion  
Address  Department of Anesthesia 4th floor College building Lokmanya Tilak Municipal General Hospital Sion

Mumbai
MAHARASHTRA
400022
India 
Phone  9769215359  
Fax    
Email  drpreetirustagi@gmail.com  
 
Source of Monetary or Material Support  
Lokmanya Tilak Municipal General Hospital Sion Mumbai Maharashtra India 400022 
 
Primary Sponsor  
Name  Lokmanya Tilak Municipal General Hospital and Medical College 
Address  Sion Mumbai Maharashtra 400022 
Type of Sponsor  Government 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 Preeti Rustagi   Lokmanya Tilak Municipal General Hospital Sion   Department of Anesthesia 4th floor College building Lokmanya Tilak Municipal Medical College Sion Mumbai Maharashtra 400022
Mumbai
MAHARASHTRA 		 9769215359

drpreetirustagi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Human Research   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G958||Other specified diseases of spinalcord,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patients with traumatic onset of lumbar radiculopathy.
2. Patients with loss of motor power of lower limbs.
3. Local or systemic infection.
4. History of inflammatory rheumatic diseases/ ankylosing spondylitis 
 
ExclusionCriteria 
Details  1. Patients with traumatic onset of lumbar radiculopathy.
2. Patients with loss of motor power of lower limbs.
3. Local or systemic infection.
4. History of inflammatory rheumatic diseases/ ankylosing spondylitis 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To observe and analyse the effect of patient related factors like age, sex, BMI and co morbid conditions on
treatment success after TFESI .
2. To observe and analyse effect of clinical findings like duration of pain, intensity of pain prior to procedure,
history of any inciting event or presence of depression, on the treatment success after TFESI
3. To observe and analyse effect of Radiological findings on MRI, on treatment success after TFESI 		 1hour Day 1 1week 1month 3months  
 
Secondary Outcome  
Outcome  TimePoints 
To observe & analyse predictive factors related to patient demographics, clinical history, symptoms & radiological findings
follow up period. 		 1hour Day 1 1week 1month 3months  
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   01/05/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  01/05/2024 
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)   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  
Lumbosacral disc herniation is a common cause of chronic low back pain in
adults. Disc herniation induced pain is triggered by mechanical compression on
the dorsal root or ganglion of the herniated disc material or inflammation induced
by chemokines and enzymes in the disc(1). This pain is usually characterized by
pain arising in the back with or without radiation to lower limb in distribution in
one or more nerves.
Transforaminal epidural steroid injection (TFESI) involves instillation of
corticosteroids around the inflamed nerve root along with low concentration
solution of local anaesthetic . Fluoroscopy guided injection is given through the
intervertebral foramen into the ventral epidural space close to the pathological
site. This helps alleviate the pain by anti-inflammatory and neural membrane
stabilization effects of steroids, increase blood flow to ischemic spinal root
through local anaesthetic agent and removal of cytokines by washout effect of
injection(2,3) . This technique for treatment of lumbosacral radiculopathy is a
cost effective procedure in the majority of cases as compared to other operative
interventions. Complications associated with surgery such as recurrence,
cerebrospinal fluid leakage , haematoma and infections can be avoided . Despite
the established efficacy of TFESI for disc herniation related pain, successful
outcomes may not be obtained in all patients. There could be several variable
factors which might have an impact on treatment outcome in the immediate post
procedure period and later on. These factors could be patient related factors,
clinical or radiological findings. With the need to reduce low value healthcare it
would be helpful to be able to better identify patients who have a reasonable
chance of benefiting from ESI. Therefore this study aims to identify predictive factors for successful treatment outcome 3 months after TFESI in patients with
lumbosacral disc herniation induced pain.
 
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