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临床试验/EUCTR2014-002751-25-GB
EUCTR2014-002751-25-GB进行中(未招募)1 期

Multi-centre randomised control trial comparing the clinical and cost effectiveness of trans-foraminal epidural steroid injection to surgical microdiscectomy for the treatment of chronic radicular pain secondary to prolapsed intervertebral disc herniation: NErve Root Block VErsus Surgery (NERVES) - Nerve Root Block Versus Surgery (NERVES)

The Walton Centre NHS Foundation Trust0 个研究点目标入组 148 人开始时间: 2014年8月8日最近更新:
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
148

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

入选标准

  • Patients with the following characteristics will be eligible for inclusion in the trial:
  • a.Diagnosed lower extremity radiculopathy (sciatica)
  • b.Sciatica secondary to prolapsed intervertebral disc (PID) (proven by MRI)
  • c.Duration of symptoms between 6 weeks and 12 months
  • d.Leg pain non-responsive to conservative, non-invasive management
  • e.Age 16 – 65 years
  • f.Patient has attempted at least one form of conservative (non-operative) treatment* but this has not provided adequate relief of patient’s pain/symptoms
  • g.Patient has provided written, informed consent
  • Are the trial subjects under 18? yes
  • Number of subjects for this age range: 0
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 190
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range 0

排除标准

  • Patients with the following characteristics will be excluded from the trial:
  • a.Serious neurological deficit (e.g. foot-drop/possible cauda-equina compression)
  • b.Previous spinal surgery at the same intervertebral disc (level)
  • c.Sciatica presentation for longer than 12 months
  • d.Age < 16
  • e.Age > 65
  • f.Patient has not attempted any form of conservative treatment
  • g.Any patient who has a contraindication for surgery and/or injection
  • h. Patient known to be pregnant

研究者

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