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临床试验/NCT05062993
NCT05062993已完成不适用

Evaluation of the Effect of Ultrasound Guided Caudal Epidural Pulsed Radiofrequency Stimulation on Chronic Pain in Patients With Failed Back Surgery Syndrome

Diskapi Teaching and Research Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年2月22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
30
试验地点
1
主要终点
Numeric Rating Scale

研究概览

简要总结

Postlumbar surgery syndrome (PLSS; failed back syndrome) is characterized by persistent pain in the lower back or lower extremities after spinal surgery. It occurs in 10-40% of patients who undergo a back surgery. The recently introduced pulsed radiofrequency (PRF) technique is widely used to provide relief from chronic pain and studies have shown that PRF stimulation can be used to control neuropathic pain by placing the needle electrodes into the caudal epidural space The aim of this study is evaluation of the effect of ultrasound guided caudal epidural pulsed radiofrequency stimulation in patients with chronic lumbosacral radicular pain due to postlumbar surgery syndrome.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • •chronic pain in legs or back pain
  • •unsatisfactory response to at least one transforaminal, lumbar or caudal steroid injections

排除标准

  • •coagulation disorders
  • •psychiatric disorders
  • •rheumatoid disorders
  • •infections

研究组 & 干预措施

study group

Experimental

Patients with chronic radicular pain will be included in this study. Ultrasound guided caudal epidural pulse radiofrequency technique will be applied to the study group.

干预措施: caudal epidural pulse radio frequency (Procedure)

结局指标

主要结局

Numeric Rating Scale

时间窗: 8 weeks after procedure

The 11-point NRS consists of numbers between 0 and 10 where 0 indicates "no pain" and 10 indicates "maximum pain." The patient is instructed to identify one number between 0 and 10, which is best representative of their pain intensity.

Numeric Rating Scale(NRS) (0-10)

时间窗: before procedure

The 11-point NRS consists of numbers between 0 and 10 where 0 indicates "no pain" and 10 indicates "maximum pain." The patient is instructed to identify one number between 0 and 10, which is best representative of their pain intensity.

Numeric Rating Scale

时间窗: 2 weeks after procedure

The 11-point NRS consists of numbers between 0 and 10 where 0 indicates "no pain" and 10 indicates "maximum pain." The patient is instructed to identify one number between 0 and 10, which is best representative of their pain intensity.

Numeric Rating Scale

时间窗: 4 weeks after procedure

The 11-point NRS consists of numbers between 0 and 10 where 0 indicates "no pain" and 10 indicates "maximum pain." The patient is instructed to identify one number between 0 and 10, which is best representative of their pain intensity.

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

Selin Guven Kose

Principal Investigator

Diskapi Teaching and Research Hospital

研究点 (1)

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