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临床试验/NCT04686903
NCT04686903已完成不适用

Prospective Comparison Between Epiduroscopy Procedure, Racz Catheter Procedure and Caudal Epidural Block in Patients With FBSS

Europainclinics z.ú.2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
150
试验地点
2
主要终点
Change from baseline EuroQoL-5 dimension (EQ-5D) value 6m

研究概览

简要总结

Prospective comparison between epiduroscopy procedure, Racz catheter procedure and caudal epidural block in patients with FBSS

详细描述

I. Epiduroscopy is an advanced proven diagnostic and therapeutic method for chronic radicular pain after spinal surgery. Moreover, this method is frequently used in patients with chronic low back pain conditions without previous spine surgery also known as "virgin back". Epiduroscopy allows by optical fiber technology and skiascopy imaging the exact examination of the epidural space and subsequently mechanical lysis (with advanced interventional options by laser, radiofrequency, balloon techniques etc.) and/or drug administration to the target point.

II. The Racz catheter procedure is based on epidural neurolysis. It is used to release some of the adhesions or scar tissue which surround entrapped nerves in the epidural space of the spine. This state could be caused by chronic inflammatory adhesions or by healing mechanisms after spine surgery - scars. Mechanical liberation of epidural space further allows better administration and targeting of drugs as corticoids or hyaluronidase. This technique is performed under fluoroscopy imaging. Suitable epidurogram and skiascopy confirm appropriate catheter position during procedure.

III. The caudal epidural block involves placing a needle through the sacral hiatus to deliver medications into the epidural space. This approach to the epidural space is popular in managing a wide variety of chronic pain conditions in adults, especially chronic low back pain syndromes. Fluoroscopy is considered as a gold standard of needle guidance during procedures in which caudal epidural injections are performed.

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
None

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients aged between 20 and 80
  • patients with FBSS (at least 1 - up to 2 lumbar laminectomies) who has radiating pain (VAS >=5) on lower extremities
  • those who (only if a signature was obtainable), or whose legal guardian, fully understood the clinical trial details and signed the informed consent form

排除标准

  • more than 2 lumbar laminectomies
  • patients without previous spine surgery
  • patients with a history of other spinal diseases (compression fracture, spondylitis, tumor)
  • women with a positive pregnancy test before the trial or who planned to become pregnant within the following 3 years
  • other patients viewed as inappropriate by the staff
  • disagreement with participation in the study

结局指标

主要结局

Change from baseline EuroQoL-5 dimension (EQ-5D) value 6m

时间窗: 6 months follow-up

EQ-5D-5L self-care, usual activities, pain/discomfort and anxiety/depression

Change from baseline EuroQoL-5 dimension (EQ-5D) value 12m

时间窗: 12 months follow-up

EQ-5D-5L self-care, usual activities, pain/discomfort and anxiety/depression

Change from baseline Visual Analog Pain Scale (VAS) of back pain 12 m

时间窗: 12 months follow-up

VAS 10 point measurement

Oswestry disability index (ODI) 12m

时间窗: 12 months follow-up

he ODI self-administered questionnaire measuring 0-100 scale function.'' The questionnaire comprises 10 items, each with 6 levels of response. Each item is scored from 0 to 5, and the total summation is converted to a 0-100 scale. The ODI scores range from 0 to 100, with higher scores indicating severe symptoms.

Change from baseline Visual Analog Pain Scale (VAS) of back pain 6m

时间窗: 6 months follow-up

VAS 10 point measurement

Oswestry disability index (ODI) 6m

时间窗: 6 months follow-up

he ODI self-administered questionnaire measuring 0-100 scale function.'' The questionnaire comprises 10 items, each with 6 levels of response. Each item is scored from 0 to 5, and the total summation is converted to a 0-100 scale. The ODI scores range from 0 to 100, with higher scores indicating severe symptoms.

次要结局

  • Before procedure drug usage(before procedure)
  • Postprocedural drug usage(before procedure)
  • Radiation exposure(12 months follow-up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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