| CTRI Number |
CTRI/2025/07/090616 [Registered on: 09/07/2025] Trial Registered Prospectively |
| Last Modified On: |
05/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A STUDY ON THE EFFECT OF NERVE ROOT BLOCKS VERSUS STEROID INJECTIONS IN THE TREATMENT FOR BACK PAIN |
|
Scientific Title of Study
|
A Comparative Study on the Efficacy of Selective Nerve Root Blocks Versus Epidural STteroid Injection in the Treatment for Single Level Intervertebral Disc Prolapse |
| 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 Pradeep Raj Kanickairaj |
| Designation |
Post Gradute Resident |
| Affiliation |
St Peters Medical College Hospital Research Institute |
| Address |
M 105 7th Floor Marvel Towers TNHB Apartments 4th Avenue Indira Nagar Adyar Chennai 600020
Dr. MGR Nagar, opp to SIPCOT, HOSUR 635130
Dharmapuri
TAMIL NADU
600020
India |
| Phone |
9445947021 |
| Fax |
|
| Email |
pradeepjohnsasi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Channabavasa Patil |
| Designation |
Professor |
| Affiliation |
St Peters Medical College Hospital Research Institute |
| Address |
Dr. MGR Nagar, opp to SIPCOT, HOSUR 635130
Dr. MGR Nagar, opp to SIPCOT, HOSUR 635130
Dharmapuri
TAMIL NADU
635130
India |
| Phone |
9445947021 |
| Fax |
|
| Email |
patilortho@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradeep Raj Kanickairaj |
| Designation |
Post Gradute Resident |
| Affiliation |
St Peters Medical College Hospital Research Institute |
| Address |
M 105 7th Floor Marvel Towers TNHB Apartments 4th Avenue Indira Nagar Adyar Chennai 600020
Dr. MGR Nagar, opp to SIPCOT, HOSUR 635130
Dharmapuri
TAMIL NADU
600020
India |
| Phone |
9445947021 |
| Fax |
|
| Email |
pradeepjohnsasi@gmail.com |
|
|
Source of Monetary or Material Support
|
| St. Peters Medical College, Hospital and Research Institute
Dr. M.G.R. Nagar, HOSUR - 635130, Krishnagiri Dt., TamilNadu, India |
|
|
Primary Sponsor
|
| Name |
Individual |
| Address |
St. Peters Medical College, Hospital and Research Institute
Dr. M.G.R. Nagar, HOSUR - 635130, Krishnagiri Dt., TamilNadu, India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Pradeep Raj K |
Orthopaedic Department Out Patient Room in Hospital |
St. Peters Medical College, Hospital and Research Institute
Dr. M.G.R. Nagar, HOSUR - 635130, Krishnagiri Dt., TamilNadu, India
Dharmapuri
TAMIL NADU |
9445947021
pradeepjohnsasi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M95||Other acquired deformities of musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Epidural Steroid Injection |
corticosteroid medication is injected into the caudal epidural space in the lower back to reduce pain |
| Intervention |
Selective Nerve root block |
local anesthetic and steroid is injected near a specific spinal nerve root for pain management |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Failed to respond to conservative therapy for duration of more than 6 weeks
MRI suggestive of Single level Inter Vertebral Disc Prolapse with Unilateral or Bilateral Radiculopathy
|
|
| ExclusionCriteria |
| Details |
Prior back or Spinal surgeries
Patients having other co-morbidities who are not fit for surgery
Systemic and local Infections
Neoplastic and vascular causes
Case of Multi-level Inter Vertebral Disc Prolapse
Patients with Pain more than 1 year |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain management with Vas Score reduction in follow Up after both procedures |
1st month 2nd month 3rd month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/09/2025 |
| 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 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
|
The study is being conducted to evaluate and compare the outcomes of Selective Nerve Root Block and Epidural steroid injection according to Visual Analogue Scoring system for Pain after 1st, 2nd and 3rd month |