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CTRI Number  CTRI/2019/11/021898 [Registered on: 06/11/2019] Trial Registered Prospectively
Last Modified On: 05/11/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   COMPARISON OF TRANSFORAMINAL EPIDURAL INJECTION OF DEXAMETHASONE AND METHYLPREDNISOLONE IN REDUCING LOW BACK PAIN AND DISABILITY IN PROLAPSED LUMBAR INTERVERTEBRAL DISC 
Scientific Title of Study   COMPARISON OF TRANSFORAMINAL EPIDURAL INJECTION OF DEXAMETHASONE AND METHYLPREDNISOLONE IN REDUCING LOW BACK PAIN AND DISABILITY IN PROLAPSED LUMBAR INTERVERTEBRAL DISC AMONGST THE INDIGENOUS POPULATION OF MANIPUR, INDIA: A RANDOMIZED CONTROLLED TRIAL 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kanti Rajkumari 
Designation  Post graduate trainee 
Affiliation  Regional Institute of Medical Sciences 
Address  Department of PMR, RIMS, Imphal
Sagolband Bijoy Govind, Imphal West, Manipur
Imphal West
MANIPUR
795004
India 
Phone  08118941525  
Fax    
Email  kantiaarkay@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Akoijam Joy Singh 
Designation  Professor 
Affiliation  Regional Institute of Medical Sciences 
Address  Department of PMR, RIMS, Imphal

Imphal West
MANIPUR
795004
India 
Phone  9436026960  
Fax    
Email  joyakoijam2@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Kanti Rajkumari 
Designation  Post graduate trainee 
Affiliation  Regional Institute of Medical Sciences 
Address  Department of PMR, RIMS, Imphal
Sagolband Bijoy Govind, Imphal West, Manipur
Imphal West
MANIPUR
795004
India 
Phone  08118941525  
Fax    
Email  kantiaarkay@gmail.com  
 
Source of Monetary or Material Support  
RIMS Imphal 
 
Primary Sponsor  
Name  Dr Kanti Rajkumari 
Address  Department of PMR, RIMS, IMPHAL, MANIPUR 
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 Kanti Rajkumari  Regional Institute of Medical Sciences  Department of PMR
Imphal West
MANIPUR 		 08118941525

kantiaarkay@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Research Ethics Board, RIMS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G544||Lumbosacral root disorders, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Fluoroscopic guided transforaminal epidural steroid injection of dexamethasone in prolapsed lumbar intervertebral disc  Patient was placed in a prone position and using an ipsilateral oblique fluoroscopic view, the x-ray tube of the C-arm fluoroscope was angulated in a caudal direction to square the inferior endplate of the vertebral body, and to place the superior articular process of the subjacent segment pointing at 6 o’clock of the pedicle of the above level that appears as a Scottie dog eye. Local skin was then prepped and draped in a sterile manner. A local skin wheel was raised with 1% lidocaine at the needle entry site and the subcutaneous tissue in the needle trajectory path infiltrated with 1% lidocaine. A 22 gauge spinal needle of appropriate length was inserted and directed down and parallel to the fluoroscopic beam toward the “safe triangle.” To avoid deep needle placement and potential injury to the vasculature or nerve root or DRG in the neuroforamen, the needle was advanced until the needle tip touched the lower edge of the Scottie dog eye. Further advancement of the needle was done under AP and lateral views. The final needle tip position was at the posterior half of the neuroforamen just under the pedicle in the lateral view to minimize the potential injury to the vasculature, nerve root, or DRG. In the AP view, the needle tip should not be medial to the medial edge of the pedicle to avoid penetrating the dura mater. For the L5-S1 foramen, the C-arm source often needs to be tilted in a caudal direction to accommodate any remaining lumbar lordosis. An ipsilateral oblique projection was then used to visualize the Scottie dog and the target was identified as the region immediately under the pedicle, slightly lateral to the 6 o’clock position. This position leads to needle placement in the neuroforamen, ventral to the nerve root. Lateral imaging was used to demonstrate the needle depth, which was located at the superior portion of the intervertebral foramen, just under the pedicle. An AP view was obtained to ensure that the needle tip was located at the “safe triangle”, slightly lateral to the 6 o’clock position of the pedicle. A needle position located within the safe triangle and lateral to the 6 o’clock position is deemed safe because it will not penetrate the nerve, blood vessels, or dura mater. Nevertheless, because of the precarious location of the nerve root and the dorsal root ganglion, caution was exercised by advancing the needle slowly upon entering the neuroforamen, to avoid needle penetration of these neurologic structures. Once the needle was deemed at the proper position, approximately 1.0 mL of the contrast was injected under live fluoroscopic view. The needle was redirected if there was vascular uptake of the contrast. The injected contrast ideally outlined the nerve root and also show epidural spread. For intervention group, 16 mg of Dexamethasone Sodium Phosphate was slowly injected into the neuroforamen through the spinal needle.  
Comparator Agent  Fluoroscopic guided transforaminal epidural steroid injection of methylprednisolone in prolapsed lumbar intervertebral disc  Patient was placed in a prone position and using an ipsilateral oblique fluoroscopic view, the x-ray tube of the C-arm fluoroscope was angulated in a caudal direction to square the inferior endplate of the vertebral body, and to place the superior articular process of the subjacent segment pointing at 6 o’clock of the pedicle of the above level that appears as a Scottie dog eye. Local skin was then prepped and draped in a sterile manner. A local skin wheel was raised with 1% lidocaine at the needle entry site and the subcutaneous tissue in the needle trajectory path infiltrated with 1% lidocaine. A 22 gauge spinal needle of appropriate length was inserted and directed down and parallel to the fluoroscopic beam toward the “safe triangle.” To avoid deep needle placement and potential injury to the vasculature or nerve root or DRG in the neuroforamen, the needle was advanced until the needle tip touched the lower edge of the Scottie dog eye. Further advancement of the needle was done under AP and lateral views. The final needle tip position was at the posterior half of the neuroforamen just under the pedicle in the lateral view.In the AP view, the needle tip should not be medial to the medial edge of the pedicle to avoid penetrating the dura mater. Nevertheless, because of the precarious location of the nerve root and the dorsal root ganglion, caution was exercised by advancing the needle slowly upon entering the neuroforamen, to avoid needle penetration of these neurologic structures. Once the needle was deemed at the proper position, approximately 1.0 mL of the contrast was injected under live fluoroscopic view. The needle was redirected if there was vascular uptake of the contrast. The injected contrast ideally outlined the nerve root and also show epidural spread. For comparator group, 80 mg of methylprednisolone acetate was slowly injected into the neuroforamen through the spinal needle. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  Patients with back pain due to prolapsed lumbar disc L4-L5 and L5-S1, confirmed by MRI (Grade II and III), Pain severity with minimum score of 5 based on 10 point scale VAS (Visual Analogue Scale),Pain duration < 3 months, ODI score more than 40, Willingness to comply with treatment and follow-up assessments
 
 
ExclusionCriteria 
Details  1. Cauda equina syndrome
2. Mental or physical condition that would invalidate evaluation results
3. Prior lumbar surgery at any level
4. Patient is scheduled to have more than one level of steroid injection
5. Pregnancy
6. Systemic or local infection at site of injection
7. Known allergy to corticosteroids, contrast dye or anesthetics
8. History of any malignancy (including hematologic and non-hematologic malignancies)
9. Bleeding disorders
10. Uncontrolled diabetes mellitus/ hypertension
11. Received any spinal injection in the past 3 months
12. Subjects who refused to sign informed consent
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Visual Analogue Scale(VAS)
2. Oswestry Disability Index(ODI)
 		 1 week, 1 month, 6 months
 
 
Secondary Outcome  
Outcome  TimePoints 
SLRT  1 week, 1 month, 6 months 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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 1 
Date of First Enrollment (India)   13/11/2019 
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="5" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Low back pain affects people of all ages, from children to the elderly, and is a very frequent reason for medical consultations. Lifetime prevalence of low back pain can be as high as 84 %. Lumbar disc prolapse represents the tensile failure of the annulus fibrosus to contain the gel-like nuclear portion of  the disc. The problem of low back pain due to  prolapsed  intervertebral disc is of great importance in this part of the world, because people in this part are subjected to various physical stress either due to their peculiar living habits, low socioeconomic status or are subjected to live, work at places with poor infrastructure. Injection of corticosteroids into the epidural space has long been used as a treatment for low back  pain due to disc herniation or degeneration. Commonly used corticosteroids in ESI include dexamethasone, betamethasone, methylprednisolone, and triamcinolone. As compared to methylprednisolone, the pharmacological property of dexamethasone as a potent anti inflammatory, least likelihood of causing embolic events and being less costly contemplated us to conduct a study with an aim to assess the clinical results, with regard to decreasing pain and disability, of  transforaminal epidural steroid injection of  dexamethasone  and  methylprednisolone in prolapsed intervertebral disc. A prospective randomized study shall be done in the Department of Physical Medicine and Rehabilitation, Regional Institute of Medical Sciences, Imphal to compare the efficacy of transforaminal epidural injection of  Methylprednisolone and Dexamethasone in reducing low back pain and disability in prolapsed lumbar intervertebral disc. The outcome variables will be measured before starting intervention (baseline) and at 1 week, 1 month and 6 months post-intervention follow up. Data will be analyzed by using SPSS Version 21. For descriptive statistics, mean and standard deviation will be used whenever found suitable. For analytical statistics, independant t-test will be used and p value <0.05 will be taken as significant.

 
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