| 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
|
|
|
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
|
|
|
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 |
|
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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 |
| 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. |