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临床试验/NCT02461654
NCT02461654终止不适用

EuroPainClinics® Study III (Prospective Observational Study)

Europainclinics z.ú.1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2018年12月31日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
150
试验地点
1
主要终点
Pain as assessed by the Visual analogue scale

研究概览

简要总结

In this prospective observational trial the effect of the Disc FX microinvasive therapy should be examined in (approximately 150) adult patients with low back pain.

详细描述

Patients will be selected from 4 participating clinics from Czech and Slovak republic. Trial will compare evolution of patient's health state, changes of low back pain and other neurological conditions during time period (6 and 12 month) after miniivasive interventional pain release procedure - disc FX.

Back pain due to Lumbar Disc Disease in our population is a very common problem. The treatment options range from physiotherapy to fusion surgery. When all conservative treatment is failed than in some cases with suitable conditions of intervertebral disc is possible to avoid classical disc surgery with minimally invasive surgery techniques. A number of minimally invasive procedures have also been developed in the recent past for its management. One of them is Disc FX procedure. Disc FX is an innovative system allowing for a safe and effective approach to a damaged disc without injury to the surrounding structures. This method provides an option for those people who have not benefited from conservative treatment, and are not yet ready for major surgery. It is a minimal-access procedure performed on an out-patient basis. Its big advantage is the fact that the patient may go home the same day. The procedure consists of three phases: during the first phase, the disc is punctured with a special needle that functions as a working channel. This needle is used to remove part of the degenerate inner tissue. Then, using a radio-frequency probe, the disc is sealed to minimize the risk of repeated herniation. In the final step, the pathological nerves in the back part of the disc are destroyed with the use of radio-frequency.

Trial will compare evolution of patient's health state, changes of low back pain and other neurological conditions during time period (6 and 12 month) after miniivasive interventional pain release procedure - disc FX.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Patients who undergo Disc FX therapy

排除标准

  • 未提供

结局指标

主要结局

Pain as assessed by the Visual analogue scale

时间窗: 3 years

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

次要结局

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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