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CTRI Number  CTRI/2026/04/107545 [Registered on: 02/04/2026] Trial Registered Prospectively
Last Modified On: 23/03/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   How Effective Are Ultrasound-Guided Tailbone Injections at Easing Chronic Lower Back Pain and Boosting Daily Mobility in Adults? 
Scientific Title of Study   Effectiveness of Ultrasound-Guided Caudal Epidural Injections in Reducing Pain and Improving Function in Adults with Chronic Low Back Pain: 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  Kavin Khatri 
Designation  Assistant Professor  
Affiliation  PGIMER Sangrur 
Address  Room No. 304, Department of Orthopaedics, PGIMER Satellite Centre, Sangrur-148001, Punjab, India
Room No. 304, Department of Orthopaedics, PGIMER Satellite Centre, Sangrur-148001, Punjab, India
Sangrur
PUNJAB
148001
India 
Phone  08872783564  
Fax    
Email  kavinkhatri84@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Kavin Khatri 
Designation  Assistant Professor  
Affiliation  PGIMER Sangrur 
Address  Room No. 304, Department of Orthopaedics, PGIMER Satellite Centre, Sangrur-148001, Punjab, India
Room No. 304, Department of Orthopaedics, PGIMER Satellite Centre, Sangrur-148001, Punjab, India

PUNJAB
148001
India 
Phone  08872783564  
Fax    
Email  kavinkhatri84@gmail.com  
 
Details of Contact Person
Public Query  
Name  Kavin Khatri 
Designation  Assistant Professor  
Affiliation  PGIMER Sangrur 
Address  Room No. 304, Department of Orthopaedics, PGIMER Satellite Centre, Sangrur-148001, Punjab, India
Room No. 304, Department of Orthopaedics, PGIMER Satellite Centre, Sangrur-148001, Punjab, India

PUNJAB
148001
India 
Phone  08872783564  
Fax    
Email  kavinkhatri84@gmail.com  
 
Source of Monetary or Material Support  
Postgraduate institute of medical education and Research Satellite Center , Sangrur 
 
Primary Sponsor  
Name  nil 
Address  nil 
Type of Sponsor  Research institution and hospital 
 
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 
DrKavin Khatri  Postgraduate Institute of Medical Education and Research Satellite Centre Sangrur  Room No. 304 Department of Orthopaedics PGIMER Satellite Centre Sangrur Punjab India Room No. 304, Department of Orthopaedics, PGIMER Satellite Centre, Sangrur-148001, Punjab, India
Sangrur
PUNJAB 		 08872783564

kavinkhatri84@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
PGIMER CHANDIGARH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: M511||Thoracic, thoracolumbar and lumbosacral intervertebral disc disorders with radiculopathy,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Adults aged 18 to70 years Chronic low back pain with radiculopathy for more than 12 weeks MRI-confirmed lumbosacral radiculopathy 
 
ExclusionCriteria 
Details  Pregnancy or lactation; Coagulopathy or ongoing anticoagulant therapy; Known hypersensitivity to injectables 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Pain reduction measured using the Visual Analog Scale at baseline two weeks one month three months six months and twelve months  1 month, 3 months, 6 months and 12 months 
 
Secondary Outcome  
Outcome  TimePoints 
Functional improvement using Oswestry Disability Index (ODI)  1 month, 3 months, 6 months, and 12 months 
 
Target Sample Size   Total Sample Size="400"
Sample Size from India="400" 
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)   08/04/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  08/04/2026 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="1"
Days="1" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

This prospective observational study assesses the effectiveness of ultrasound guided caudal epidural injections for adults with chronic low back pain and radiculopathy. Participants receive an ultrasound guided injection containing ropivacaine combined with either triamcinolone or methylprednisolone. The study measures pain levels using the Visual Analog Scale, functional improvement using the Oswestry Disability Index, patient satisfaction, mobility, nerve function, and safety over a period of twelve months. Outcomes are compared between the two corticosteroid groups. Ultrasound guidance eliminates radiation exposure compared to traditional fluoroscopy methods and may offer better safety and wider availability. The procedure carries no additional risks beyond standard care. Participation remains completely voluntary.


 
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