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CTRI Number  CTRI/2024/06/069051 [Registered on: 18/06/2024] Trial Registered Prospectively
Last Modified On: 14/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Epidural Injection With or Without Steroid For Low Back Pain 
Scientific Title of Study   Efficacy Of Interlaminar Epidural Injection With or Without Steroid For Low Back Pain Due To Lumbar Canal Stenosis: A Randomised Double Blind 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  PAWAN KUMAR DUBEY 
Designation  PG RESIDENT 
Affiliation  GEETANJALI MEDICAL COLLEGE AND HOSPITAL 
Address  ROOM- B6, PAIN CLINIC, GROUND FLOOR, GEETANJALI MEDICAL COLLEGE AND HOSPITAL

Udaipur
RAJASTHAN
313001
India 
Phone  08009662664  
Fax    
Email  pawandubey131@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR ANIL KUMAR BHIWAL 
Designation  ASSOCIATE PROFESSOR 
Affiliation  GEETANJALI MEDICAL COLLEGE AND HOSPITAL 
Address  SECOND FLOOR, ANAESTHESIA DEPARTMENT, GEETANJALI MEDICAL COLLEGE AND HOSPITAL

Udaipur
RAJASTHAN
313001
India 
Phone  9799185525  
Fax    
Email  anilbhiwal@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  DR ANIL KUMAR BHIWAL 
Designation  ASSOCIATE PROFESSOR 
Affiliation  GEETANJALI MEDICAL COLLEGE AND HOSPITAL 
Address  SECOND FLOOR, ANAESTHESIA DEPARTMENT, GEETANJALI MEDICAL COLLEGE AND HOSPITAL

Udaipur
RAJASTHAN
313001
India 
Phone  9799185525  
Fax    
Email  anilbhiwal@yahoo.co.in  
 
Source of Monetary or Material Support  
GEETANJALI HOSPITAL, MANWAKHERA, NH-8 BYPASS, NEAR EKLINGPURA CHOURAHA, RAJASTHAN 313001 
 
Primary Sponsor  
Name  DR PAWAN KUMAR DUBEY 
Address  GEETANJALI MEDICAL COLLEGE AND HOSPITAL , UDAIPUR, RAJASTHAN 
Type of Sponsor  Other [SELF] 
 
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 PAWAN KUMAR DUBEY  GEETANJALI HOSPITAL  ROOM B-6, GROUND FLOOR, GEETANJALI MEDICAL COLLEGE AND HOSPITAL
Udaipur
RAJASTHAN 
8009662664

pawandubey131@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ETHICAL CLEARENCE CERTIFICATE   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G892||Chronic pain, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  INTERLAMINAR EPIDURAL INJECTION  epidural injection with steroid: Ropivacaine (0.2%) 5ml + Triamcinolone 40 mg (1 ml)  
Comparator Agent  INTERLAMINAR EPIDURAL INJECTION  epidural injection without steroid: Ropivacaine (0.2%) 5ml + normal saline (0.9 %) 1 ml 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients having chronic lower back pain due lumbar canal stenosis as evident from radiological findings on MRI. 
 
ExclusionCriteria 
Details  Patients with-
1) Contraindication to the procedure (active, local or systemic infections), coagulopathy, use of anti thrombotic or anti platelet medications.
2) History of allergy to contrast medium or injected medication.
3)Previous history of low back surgery.
4)Lower Back Pain due to PIVD.
5)Pre-existing uncontrolled hypertension, uncontrolled diabetes mellitus type 2.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate and compare the efficacy of lumbar interlaminar epidural injection (ILEI) with following parameters in both the groups:
a) Reduction of pain by visual analogue scale (VAS) at 1, 3 and 6 months.
b) Improvement of functional status by walking distance and Revised Oswestry Disability Index at 1, 3 and 6 months.
 
a) Reduction of pain by visual analogue scale (VAS) at 1, 3 and 6 months.
b) Improvement of functional status by walking distance and Revised Oswestry Disability Index at 1, 3 and 6 months.
 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the following parameters in both groups:
a) Requirement of repeat ILEI.
b) Adverse effects (PDPH, hypotension, bradycardia, nausea/vomiting, vasovagal reaction intrathecal/intravascular injection, allergic reactions etc.)
 
At 4 weeks , 12 weeks & 48 Weeks 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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)   30/06/2024 
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="7"
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  

 Spinal canal stenosis is the narrowing of the spinal canal which results in spinal cord and spinal nerve compression. It can cause  back and leg pain, limb weakness, and numbness. Patients with symptomatic spinal canal stenosis have reduced activity which further leads to development of other serious complications.

The cause of the disease is generally degenerative. Acquired spinal canal stenosis is very common among elderly patients, with a prevalence of 1.7% - 13.1%. Primary treatment is conservative management, but in many cases when conservative therapy is not effective then surgical treatment is selected. But even after surgery symptoms may persist and long term benefits of surgery is reported to be less compared to conservative management. The risk of anesthesia and postoperative complication is also increased in elderly patients.

An epidural steroid injection is a non-operative minimally invasive procedure used for pain relief in spinal canal stenosis. The main aim is providing effective and long lasting pain relief with improvement in functional status for the management of chronic back pain and lower extremity pain. Various studies have been conducted to evaluate the efficacy of this treatment in the management of patients with spinal canal stenosis with highly variable success rate, still there is no consensus on its effect size nor on the timing of the trial, frequency, and duration of treatment. So further studies are required to understand the effectiveness of epidural steroid injection in the treatment of spinal canal stenosis.

Therefore this study is planned to evaluate the efficacy of interlaminar epidural steroid injection for back pain due lumbar canal stenosis.

 
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