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临床试验/NCT05533723
NCT05533723已完成不适用

Comparison Between Endoscopic Epidural Neuroplasty and Percutaneous Epidural Neuroplasty With a Steering Catheter in Low Back and Radicular Pain

Ajou University School of Medicine1 个研究点 分布在 1 个国家目标入组 107 人开始时间: 2018年10月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
107
试验地点
1
主要终点
visual analog scale

研究概览

简要总结

PEN(percutaneous epidural neuroplasty) can be performed percutaneously, may be manipulated to mechanically break up adhesions by catheter, while various agents, such as anesthetics, corticosteroids, hyaluronidase, and hypertonic saline are injected. In endoscopic epidural neuroplasty (EEN), a flexible catheter is inserted into the sacral hiatus to precisely place the injection in the epidural space and onto the nerve root. Both EEN and PEN can eliminate the deleterious effects of scar formation, which can physically prevent the direct application of drugs to the nerves, and may provide pain relief in patients who have not responded to epidural blocks, physical therapy, or medication. In this study, visual analog scale (VAS) and Oswestry disability index (ODI) of patients with low back and radicular pain were compared in patients who had received EEN or PEN at 1 day, 1 month, and 6 months after EEN or PEN.

详细描述

Low back pain and lumbar radicular pain commonly occur in degenerative spondy-losis. Low back and radicular pain have many underlying causes, one of which is scar-ring in the epidural space, which can cause pain for many reasons. The nerves may be trapped by scars, while the congestive veins in the epidural space can become enlarged and exert pressure upon the nerves.

Percutaneous epidural neuroplasty (PEN) with a wire type catheter, first reported by Dr. Racz, has been widely practiced since 1989, and reduces pain by epidural adhesiolysis, epidural fibrosis and inflammation near the neural tissue.

The PEN procedure is used to dissolve some scar tissue around the entrapped nerves in the epidural space of the spine. PEN can be performed percutaneously, using a Racz catheter. The catheter may be manipulated to mechanically break up adhesions, while various agents, such as anesthetics, corticosteroids, hyaluronidase, and hypertonic saline are injected. In endoscopic epidural neuroplasty (EEN), a flexible catheter is inserted into the sacral hiatus to precisely place the injection in the epidural space and onto the nerve root. Both EEN and PEN can eliminate the deleterious effects of scar formation, which can physically prevent the direct application of drugs to the nerves, and may pro-vide pain relief in patients who have not responded to epidural blocks, physical therapy, or medication.

In this study, visual analog scale (VAS) and Oswestry disability index (ODI) of pa-tients with low back and radicular pain were compared in patients who had received EEN or PEN at 1 day, 1 month, and 6 months after EEN or PEN.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

接受健康志愿者

入选标准

  • age over 20 years
  • low back or radicular pain in the low extremities
  • persistent low back or radicular pain

排除标准

  • systemic infection
  • skin infection at the injection site
  • uncontrolled diabetes mellitus
  • coagulation abnormalities
  • history of allergic reactions to local anesthetics or contrast agents

结局指标

主要结局

visual analog scale

时间窗: 6 months after EEN or PEN

11 points pain scale score from 0 to 10

Oswestry disability index

时间窗: 6 months after EEN or PEN

disability index from 0 to 100%

次要结局

  • height(before EEN or PEN)
  • weight(before EEN or PEN)

研究者

发起方
Ajou University School of Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jong Bum Choi

professor

Ajou University School of Medicine

研究点 (1)

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