Skip to main content
Clinical Trials/CTRI/2019/11/021898
CTRI/2019/11/021898Not yet recruitingPhase 1

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

Dr Kanti Rajkumari1 site in 1 country80 target enrollmentStarted: November 13, 2019Last updated:

Trial Snapshot

Phase
Phase 1
Status
Not yet recruiting
Sponsor
Enrollment
80
Locations
1
Primary Endpoint
2. Oswestry Disability Index(ODI)

Study Overview

Brief Summary

Lowback pain affects people of all ages, from children to the elderly, and is avery frequent reason for medical consultations. Lifetime prevalence of low backpain can be as high as 84 %. Lumbar disc prolapserepresents the tensile failure of the annulus fibrosus to contain the gel-likenuclear 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 dueto their peculiar living habits, low socioeconomic status or are subjected tolive, work at places with poor infrastructure. Injection ofcorticosteroids into the epidural space has long been used as a treatment forlow back  pain due to disc herniation ordegeneration. Commonly used corticosteroids in ESI include dexamethasone,betamethasone, methylprednisolone, and triamcinolone. As compared to methylprednisolone, thepharmacological property of dexamethasone as a potent anti inflammatory, leastlikelihood of causing embolic events and being less costly contemplated us toconduct a study with an aim to assess the clinical results, with regard to decreasing pain anddisability, of  transforaminal epiduralsteroid injection of  dexamethasone  and methylprednisolone in prolapsed intervertebral disc. Aprospective randomized study shall be done in the Department of PhysicalMedicine and Rehabilitation, Regional Institute of Medical Sciences, Imphal tocompare the efficacy oftransforaminal epidural injection of Methylprednisolone and Dexamethasone in reducing low back pain anddisability in prolapsed lumbar intervertebral disc. The outcomevariables will be measured before starting intervention (baseline) and at 1week, 1 month and 6 months post-intervention follow up. Data will be analyzedby using SPSS Version 21. For descriptive statistics, mean and standarddeviation will be used whenever found suitable. For analytical statistics,independant t-test will be used and p value <0.05 will be taken assignificant.

Study Design

Study Type
Interventional
Allocation
Permuted block randomization, fixed
Masking
Participant and Outcome Assessor Blinded

Eligibility Criteria

Ages
20.00 Year(s) to 55.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

2. Oswestry Disability Index(ODI)

Time Frame: 1 week, 1 month, 6 months

1. Visual Analogue Scale(VAS)

Time Frame: 1 week, 1 month, 6 months

Secondary Outcomes

  • SLRT(1 week, 1 month, 6 months)

Investigators

Sponsor
Dr Kanti Rajkumari
Sponsor Class
Other [self]

Study Sites (1)

Loading locations...

Similar Trials