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临床试验/NCT06092749
NCT06092749招募中不适用

Effectiveness of Transgrade vs Interlaminar Epidural Steroid Injection for Chronic Unilateral Lumbar Radicular Pain

Ain Shams University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年11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
招募中
入组人数
60
试验地点
1
主要终点
The average numeric rating scale (NRS) pain scores

研究概览

简要总结

Chronic neuropathic lumbar pain is among one of the most widespread complaints of patients.Many approaches have been attempted to target chronic pain, with varying efficacy and risks. Transgrade (TG) epidural injection is a new technique using a Racz- Coudé needle for epidural access at a "transgrade" angle without requiring any specialized hardware or accessories. Interlaminar (IL) epidural steroid injection (ESI) is one of the procedures that involves the delivery of injectate to the epidural space through directing a needle between the laminae of two adjacent vertebrae.

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
Double (Participant, Care Provider)

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • > 6-month history of persistent pain in one leg with back pain.
  • Capable of giving informed consent.
  • Unsatisfactory response to conventional treatments including physical therapy or medications with a numeric rating scale (NRS) ≥ 5.

排除标准

  • Previous lumbar spinal surgery.
  • Myelopathy.
  • Rheumatoid disorders.
  • Psychiatric disorders
  • Bleeding or coagulation disorders

研究组 & 干预措施

Interlaminar technique (IL)

Active Comparator

干预措施: Interlaminar technique (IL) (Other)

Transgrade technique (TG)

Active Comparator

干预措施: Transgrade technique (TG) (Other)

结局指标

主要结局

The average numeric rating scale (NRS) pain scores

时间窗: at 12 weeks after intervention

The numeric rating scale (NRS) is most commonly 0 to 10, with 0 being "no pain" and 10 being "the worst pain imaginable."

次要结局

未报告次要终点

研究者

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

Ibrahim Mamdouh Esmat

Assistant Professor of Anesthesia, Intensive Care and Pain Management Department, Faculty of Medicine, Ain- shams University, Cairo, Egypt.

Ain Shams University

研究点 (1)

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