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临床试验/NCT01928784
NCT01928784Unknown不适用

Radial Extracorporeal Shock Wave Therapy on Chronic Low Back Pain: a Prospective Controlled Study

Beijing Jishuitan Hospital1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2013年6月最近更新:
适应症

试验速览

阶段
不适用
入组人数
26
试验地点
1
主要终点
Change in Visual analogue scale scores(VAS) of patients before and after therapy

研究概览

简要总结

The aim of this prospective study is to explore the pain-alleviating effect of low-energy extracorporeal shock wave therapy(ESWT) in patients with chronic low back pain.

详细描述

26 patients who suffered from persistent symptoms for more than 3 months are going to be treated with DOLORCLAST radial extracorporeal shock wave(EMS, Swiss). Patients are assigned to two groups according to the exist of specific pain spot. Group I(have specific pain spot) received a total of 2000 impulses of 2.5 Bar; group II(controls, no specific pain spot) 4000 impulses of 2.5 Bar. Patients is going to be treated once. The efficacy of therapy is going to be evaluated by VAS scale before and after the treatment.

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 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Symptom of low back pain during last 4 weeks
  • Low back pain history for more than 3 months

排除标准

  • Have lower limbs radiating pain beyond knee joints
  • Spinal tumorous or infectious disease, fracture, ankylosing spondylitis, cauda equina syndrome or other severe spinal diseases
  • Spinal surgical history
  • Severe heart, lung, liver, kidney disease or high blood pressure
  • With cardiac pacemaker
  • Coagulopathy or thrombosis
  • Have ESW therapy or pharmaceutical treatment for low back pain during last 1 months
  • Mental illnesses or none cooperation
  • Pregnancy

结局指标

主要结局

Change in Visual analogue scale scores(VAS) of patients before and after therapy

时间窗: baseline, 1 hour after therapy

Change of Visual analogue scale score(VAS) of patients before and after shock wave therapy

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

Cheng Zeng

MD

Beijing Jishuitan Hospital

研究点 (1)

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