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临床试验/NCT02838615
NCT02838615已完成不适用

Comparison of Lumbar Epidural Steroid Injection: Transforaminal vs. Parasagittal Interlaminar Approach

Keimyung University Dongsan Medical Center0 个研究点目标入组 56 人开始时间: 2016年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
56
主要终点
Clinical efficacy

研究概览

简要总结

The purpose of this study is to compare the clinical efficacy, incidence of ventral epidural spreading and provocation of concordant paresthesia, amount of radiation exposure and total procedure time between transforaminal and parasagittal interlaminar epidural injection.

详细描述

Participants were randomly allocated to receive either parasagittal interlaminar or transforaminal ESI.

Investigators obtained clinical data including age, gender, duration of symptoms, predominant symptoms (axial pain vs. leg pain), severity of neurogenic intermittent claudication (NIC) and degree of depression. Depression was assessed by the Korean version of the Beck Depression Inventory (BDI). The BDI is a standardized questionnaire to assess cognitive, affective, and somatic symptoms of depression. All data were obtained before performing ESI.Data about anterior epidural spreading and presence of concordant pain provocation were obtained during fluoroscopic guided parasagittal interlaminar or transforaminal ESI. Also total procedure time and amount of radiation exposure were checked. Investigators observed the epidural spread pattern after a 2 ml injection of contrast material, confirmed anterior epidural spread with a lateral view, and asked the participants if they had any concordant pain provocation or not. The participants were asked if the pain was in the same distribution as their original pain (concordant) or dissimilar or absent in both quality and location.

Investigators used the numerical rating scale (NRS) as well as the Korean version of the Oswestry Disability Index (ODI) to evaluate clinical efficacy in terms of reducing pain and functional improvement at pretreatment and 2 weeks after the ESI series. ESI was performed twice with a 2 weeks interval before the final treatment outcome evaluation with the NRS and ODI. All patients reported average severity of their symptoms over the previous 1 week. A score of 0 on the NRS represents no pain, and a score of 10 represents the worst pain imaginable. The Korean version of the ODI (0-50) was used to assess functional improvement.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

性别
All
接受健康志愿者

入选标准

  • central spinal stenosis
  • herniated nucleus pulposus.

排除标准

  • Lateral spinal stenosis
  • Internal disc disruption

研究组 & 干预措施

epidural steroid injection

Active Comparator

TF epidural steroid (dexamethasone) injection

干预措施: epidural steroid (dexamethasone) injection (Procedure)

IL epidural steroid injection

Active Comparator

PS interlaminar epidural steroid(dexamethasone) injection

干预措施: epidural steroid (dexamethasone) injection (Procedure)

结局指标

主要结局

Clinical efficacy

时间窗: 2 weeks after study completion

Numerical rating scale

次要结局

  • Intervention related time(1 minutes after the completion of the intervention)
  • Exposed radiation amount during intervention(1 minutes after the completion of the intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ji Hee Hong

Associate professor

Keimyung University Dongsan Medical Center

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