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临床试验/CTRI/2019/11/021898
CTRI/2019/11/021898尚未招募1 期

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 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2019年11月13日最近更新:

试验速览

阶段
1 期
状态
尚未招募
发起方
入组人数
80
试验地点
1
主要终点
2. Oswestry Disability Index(ODI)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Permuted block randomization, fixed
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
20.00 Year(s) 至 55.00 Year(s)(—)
性别
All

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

2. Oswestry Disability Index(ODI)

时间窗: 1 week, 1 month, 6 months

1. Visual Analogue Scale(VAS)

时间窗: 1 week, 1 month, 6 months

次要结局

  • SLRT(1 week, 1 month, 6 months)

研究者

发起方
Dr Kanti Rajkumari
申办方类型
Other [self]

研究点 (1)

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