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CTRI Number  CTRI/2023/11/059660 [Registered on: 08/11/2023] Trial Registered Prospectively
Last Modified On: 07/11/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A study to compare three different drugs, Methylprdnisolone acetate, Dexamethasone Sodium Phosphate and 5% Dextrose solution in improving pain and function in lumbar radicular pain when given as a caudal epidural injection  
Scientific Title of Study   A randomized comparative study to assess the effectiveness of Methylprdnisolone acetate, Dexamethasone Sodium Phosphate and 5% Dextrose solution through epidural in improvement of pain and function in patient with lumbar radicular pain at Sawai Man Singh medical college, Jaipur. 
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 Arpitha K 
Designation  Junior Resident  
Affiliation  SMS Medical college, Jaipur 
Address  Department of Physical medicine and rehabilitation, SMS medical college, Jaipur

Jaipur
RAJASTHAN
302004
India 
Phone  8722494112  
Fax    
Email  dr.arpitha.pmr@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Nitin Pandey  
Designation  Guide Associate professor  
Affiliation  SMS medical college  
Address  Department of Physical medicine and rehabilitation, SMS medical college, Jaipur

Jaipur
RAJASTHAN
302004
India 
Phone  9828196369  
Fax    
Email  nitinpandey12@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Nitin Pandey  
Designation  Guide Associate professor  
Affiliation  SMS medical college  
Address  Department of Physical medicine and rehabilitation, SMS medical college, Jaipur

Jaipur
RAJASTHAN
302004
India 
Phone  9828196369  
Fax    
Email  nitinpandey12@gmail.com  
 
Source of Monetary or Material Support  
SMS hospital, Jaipur, Rajasthan. 
 
Primary Sponsor  
Name  SMS hospital Jaipur Rajasthan 
Address  Department of Physical medicine and rehabilitation, SMS hospital, Jaipur  
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 Nitin Pandey   SMS hospital  Outpatient, Department of Physical medicine and rehabilitation, SMS hospital, Jaipur
Jaipur
RAJASTHAN 		 9828196369

nitinpandey12@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Office of ethics committee SMS medical college and attached hospitals, Jaipur   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G544||Lumbosacral root disorders, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  20 ml of 5% dextrose  STAT dose is given through caudal epidural route in patients with lumbar radicular pain after examination and MRI 
Comparator Agent  Dexamethasone sodium phosphate 8mg/2ml with 18ml of normal saline  STAT dose is given through caudal epidural route in patients with lumbar radicular pain after examination and MRI 
Intervention  Methylprednisolone acetate 80mg/2ml added with 18ml normal saline   STAT dose is given through caudal epidural route in patients with lumbar radicular pain after examination and MRI 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1. Those willing to give an informed written consent to participate in study.
2. Those clinically diagnosed as having lumbosacral radicular pain 
 
ExclusionCriteria 
Details  1. Patients presenting with a cauda equina syndrome, severe paresis, severe pain, history of spinal injection or surgery, deformity, warfarin therapy, ongoing treatment with non-steroidal anti-inflammatory drugs , or severe comorbidity.
2. Any medical or surgical condition preventing communication and compliance of study protocol eg. Cognitive impairment, TBI, hearing impairment etc.
3. Pregnant / lactating females. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the improvement in pain using VAS  Baseline, 4 weeks, 6 weeks &12 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
1. To compare Quality of life between the group.
2. To study various ethological factors of low back pain. 		 Baseline, 4 weeks , 6 weeks & 12 weeks  
 
Target Sample Size   Total Sample Size="180"
Sample Size from India="180" 
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 4 
Date of First Enrollment (India)   20/11/2023 
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="1"
Months="4"
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   As the lower back pain is one of the major cause of morbidities, which includes lumbar radicular pain and there is a known good effect of caudal epidural injection with steroids, so we are trying to compare the effect of two steroids (particulate & non particulate steroids) and prolotherapy in improving pain and function using VAS and ODI scale.  
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