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临床试验/CTRI/2021/08/035926
CTRI/2021/08/035926尚未招募不适用

Comparison of efficacy of nerve stimulation-assisted ultrasound-guided transforaminal injection versus ultrasound-guided transforaminal injection in patients with lumbar radicular pain: A Randomized Interventional Trial

AIIMS New Delhi1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年1月9日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
Visual Analogue Scale (VAS)

研究概览

简要总结

The lifetime prevalence of low back and sciatic pain has been reported as 54–80% with annual prevalence ranging from 15 to 45%. Lumbar transforaminal injections (TFI) are routinely performed in the interventional management of spinal radicular pain. It provides better delivery of medication to the site of radiculopathy with minimal risk of dural puncture. Unfortunately, TFI under fluoroscopic guidance results in a rather high cumulative radiation dosage for patients and medical staff. The potential biological effects of a high x-ray dosage have deterministic and stochastic effects on skin, bone, parotid glands, and the lungs. In literature, both longitudinal and transverse approaches to perform ultrasound-guided transforaminal injection (UTFI) has been described. The different studies are inconclusive to the best approach with maximal efficacy. Nerve roots exit from the upper part of the intervertebral foramen below the pedicle. To improve the efficacy of UTFI, we hypothesized that if sensory and/or motor stimulation of nerve roots can be combined with UTFI, the efficacy of the procedure will increase.  The study will be conducted with the primary objective of comparing  Visual Analogue Scale (VAS) between the groups at the end of 1 month and  secondary objectives of comparing VAS at each time period- 30 mins, 1 week and 3 months, number of needle attempts between the two groups, contrast spread pattern and operation time between the two groups. Fourty patients will be recruited satisfying the inclusion and exclusion criteria. Patients will be divided into two group: 1. Group N: Nerve stimulation-assisted ultrasound-guided transforaminal injection and 2. Group U: Ultrasound-guided transforaminal injection. Appropriate statistical analysis would be performed after compilation of data.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Low back pain with unilateral radicular pain with clinical-radiologic signs without paresis 2)VAS >3 3)18 to 65 year 4)Who gives informed consent to inclusion in the study 5)Who has current CT or MR imaging of their lumbar spine available 6)Monosegmental dermotomal pain distribution 7)Failure of symptomatic treatment with NSAIDs or/and physiotherapy for at least 6 weeks.

排除标准

  • History of drugs allergy including contrast media, steroid and anaesthetics 2)Body mass index of ≥35 kg/m2 3)Spinal infection or a local or systemic infection 4)Pregnant patient 5)Previous injections within 3 months 6)Uncontrolled diabetes 7)Spinal tumors 8)On anticoagulation therapy or uncorrectable coagulopathy 9)Underwent surgery in the lumbar region 10)Progressively neurological deficit, acute traumatic, infectious, or pathologic cases.

结局指标

主要结局

Visual Analogue Scale (VAS)

时间窗: 1 month

次要结局

  • 1. Visual Analogue Scale (VAS)(2. Number of needle attempts between the two groups)

研究者

发起方
AIIMS New Delhi
申办方类型
Research institution

研究点 (1)

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