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CTRI Number  CTRI/2025/11/097698 [Registered on: 19/11/2025] Trial Registered Prospectively
Last Modified On: 19/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   Effectiveness of USG guided caudal epidural injection in cases of low back pain 
Scientific Title of Study   Effectiveness of single dose ultrasound guided caudal epidural steroid injection in improving Nerve Conduction Study parameters, functional status , symptoms in cases of chronic lumbosacral radiculopathy due to posterolateral disc herniation. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Lt Col Dr Mohit Kataruka 
Designation  Associate Professor 
Affiliation  AIIMS Kalyani 
Address  room number 114 PMR OPD 1st floor AIIMS Kalyani NH-34 Connector, Basantapur, Saguna , Kalyani, District Nadia , West Bengal 741245
NH-34 Connector, Basantapur, Saguna , Kalyani, District Nadia , West Bengal 741245
Nadia
WEST BENGAL
741245
India 
Phone  8729912916  
Fax    
Email  mohit.pmr@aiimskalyani.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  Samriddhi Keshkar 
Designation  Junior Resident Academic 
Affiliation  AIIMS Kalyani 
Address  room number 115 PMR OPD 1st floor AIIMS Kalyani NH-34 Connector, Basantapur, Saguna , Kalyani, District Nadia , West Bengal 741245
NH-34 Connector, Basantapur, Saguna , Kalyani, District Nadia , West Bengal 741245
Nadia
WEST BENGAL
741245
India 
Phone  07980459809  
Fax    
Email  samriddhikeshkar2000@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Samriddhi Keshkar 
Designation  Junior Resident Academic 
Affiliation  AIIMS Kalyani 
Address  room number 115 PMR OPD 1st floor AIIMS Kalyani NH-34 Connector, Basantapur, Saguna , Kalyani, District Nadia , West Bengal 741245
NH-34 Connector, Basantapur, Saguna , Kalyani, District Nadia , West Bengal 741245

WEST BENGAL
741245
India 
Phone  07980459809  
Fax    
Email  samriddhikeshkar2000@gmail.com  
 
Source of Monetary or Material Support  
AIIMS Kalyani 
 
Primary Sponsor  
Name  AIIMS Kalyani 
Address  NH-34 Connector, Basantapur, Saguna , Kalyani, District Nadia , West Bengal 741245 
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 Samriddhi Keshkar  Department of PMR  AIIMS Kalyani 1st floor .NH-34 Connector, Basantapur, Saguna , Kalyani, District Nadia , West Bengal 741245
Nadia
WEST BENGAL 
07980459809

samriddhikeshkar2000@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee All India Institute of Medical Sciences, Kalyani  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Previous Spine Surgery: History of lumbar spine surgery at L4-L5, L5-S1.
2. Systemic or Local Infection: Presence of localized skin infection at the injection site or systemic infection.
3. Coagulopathy or Anticoagulant Therapy: Patients with bleeding disorders or those on anticoagulant medication without proper management.
4. Severe Neurological Deficits: Progressive motor weakness, cauda equina syndrome, or loss of bowel/bladder control.
5. Allergy to Medications: Known allergy to local anesthetics, steroids.
6. Non-Radicular Pain: Patients with purely mechanical low back pain without radiating leg symptoms.
7. Severe Comorbidities: Uncontrolled diabetes, severe cardiovascular disease, or malignancy.
8. Pregnancy or Lactation: Pregnant or breastfeeding women are usually excluded to avoid potential harm.
9. Psychiatric Disorders: Severe psychiatric illnesses that may impair pain reporting or study compliance.
10. Substance Abuse:Current or recent history of substance abuse (alcohol, opioids, or recreational drugs).
11. Sacrococcygeal tumor or fractures.
12. Patient on chronic steroids, DMARD’s & opioids.
 
 
ExclusionCriteria 
Details  1. Previous Spine Surgery: History of lumbar spine surgery at L4-L5, L5-S1.
2. Systemic or Local Infection: Presence of localized skin infection at the injection site or systemic infection.
3. Coagulopathy or Anticoagulant Therapy: Patients with bleeding disorders or those on anticoagulant medication without proper management.
4. Severe Neurological Deficits: Progressive motor weakness, cauda equina syndrome, or loss of bowel/bladder control.
5. Allergy to Medications: Known allergy to local anesthetics, steroids.
6. Non-Radicular Pain: Patients with purely mechanical low back pain without radiating leg symptoms.
7. Severe Comorbidities: Uncontrolled diabetes, severe cardiovascular disease, or malignancy.
8. Pregnancy or Lactation: Pregnant or breastfeeding women are usually excluded to avoid potential harm.
9. Psychiatric Disorders: Severe psychiatric illnesses that may impair pain reporting or study compliance.
10. Substance Abuse:Current or recent history of substance abuse (alcohol, opioids, or recreational drugs).
11. Sacrococcygeal tumor or fractures.
12. Patient on chronic steroids, DMARD’s & opioids.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
NERVE CONDUCTION STUDY
Distal Latency, aplitude, f wave latency of tibial and common peroneal nerve
H reflex latency 
AT BASELINE
2 WEEKS
4 WEEKS
6 WEEKS  
 
Secondary Outcome  
Outcome  TimePoints 
Visual analog scale to assess changes in symptom of pain  AT BASELINE
2 WEEKS
4 WEEKS
6 WEEKS  
Oswestry disability Index to assess changes in disability caused by pain to the patinet   AT BASELINE
2 WEEKS
4 WEEKS
6 WEEKS  
 
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   N/A 
Date of First Enrollment (India)   01/12/2025 
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="1"
Months="6"
Days="30" 
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  

Chronic lumbosacral radiculopathy is a frequently encountered clinical condition characterized by pain radiating from the lower back into the lower extremities, often accompanied by sensory, motor, or reflex deficits along the affected nerve root distribution. One of the most common etiologies of lumbosacral radiculopathy is posterolateral intervertebral disc herniation, which exerts mechanical compression on the adjacent nerve roots and provokes a cascade of inflammatory responses in the surrounding neural tissue . This condition not only affects the physical functionality of patients but also significantly diminishes their quality of life, leading to psychological stress and economic burden due to reduced productivity and long-term healthcare needs.

Traditional fluoroscopy-guided techniques, though effective, involve radiation exposure and may be limited in resource-constrained settings. In contrast, ultrasound-guided (USG) caudal epidural steroid injections offer a radiation-free, real-time, and cost-effective alternative that allows direct visualization of the sacral hiatus, needle advancement, and drug dispersion. Despite increasing clinical use, there remains a relative paucity of high-quality evidence evaluating the effectiveness of USG-guided CESIs, particularly focusing on electrophysiological outcomes alongside clinical parameters.

Electrophysiological studies, including nerve conduction studies (NCS) and electromyography (EMG), offer objective tools to assess the functional integrity of the affected nerve roots. While pain and functional scales provide subjective evaluation, electrophysiological parameters serve as valuable biomarkers for nerve recovery and response to treatment. This observational study aims to investigate the effectiveness of a single-dose USG-guided caudal epidural steroid injection in patients with chronic lumbosacral radiculopathy secondary to posterolateral disc herniation. Specifically, the study evaluates the intervention’s impact on electrophysiological parameters, functional status, radicular symptoms, and pain intensity over a defined follow-up period. By integrating both objective and subjective outcome measures, this research seeks to contribute meaningful data to support the broader application of USG-guided CESIs as a safe, effective, and non-surgical treatment option for managing chronic lumbosacral radiculopathy.


 
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