临床试验/NCT02742311

NCT02742311已完成不适用

EuroPainClinics® Study V (Prospective Observational Study)

Europainclinics z.ú.1 个研究点分布在 1 个国家目标入组 500 人开始时间: 2021年12月31日最近更新: 2022年1月13日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Europainclinics z.ú.
入组人数: 500
试验地点: 1
主要终点: 1.Pain as assessed by the Visual analogue scale All acquired information will be noted in to the special anonymous protocol

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

In this prospective observational trial the effect of the Endoscopic discectomy microinvasive therapy should be examined in (approximately 500) adult patients with low back pain.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 70 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•lumbar disc prolapse with unilateral radiculopathy, on clinical evaluation, positive straight leg raise or femoral stretch test, and identification of a single nerve root lesion on MRI

排除标准

•The exlusion criteria: bilateral root symptoms, double root involvement, cauda equina syndrome and negative MRI Picture for disc herniation, unsigned infomed consent

结局指标

主要结局

1.Pain as assessed by the Visual analogue scale All acquired information will be noted in to the special anonymous protocol

时间窗: 3 years

All acquired information will be noted in to the special anonymous protocol

次要结局

4. Changes in analgesics drugs consumption as assessed by equianalgesic dose ratios for opioids(3 years)
3.Pain progress as assessed by global pain scale(3 years)
2.Pain localization as assessed by note of radiating dermatome as neurologic examination(3 years)

研究者

发起方

Europainclinics z.ú.

申办方类型

Other

责任方

Sponsor

研究点 (1)

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