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临床试验/NCT00761111
NCT00761111Unknown3 期

Could a Simple Information Booklet Modify Low Back Pain Patients Beliefs After Lumbar Discectomy?

University Hospital, Clermont-Ferrand0 个研究点目标入组 140 人开始时间: 2007年6月1日最近更新:
适应症

试验速览

阶段
3 期
发起方
入组人数
140
主要终点
Quebec Questionnaire

研究概览

简要总结

The purpose of this study is to translate and assess an evidence based educational booklet on low back pain patients beliefs after lumbar discectomy.

详细描述

A translation / back-translation of the Your back operation was performed and a before / after prospective study was realized. Main outcome assessment was the Quebec Questionnaire. Demographic data, personal medical sciatica pain history, graduation of the whole subject were recorded. Acceptability of the booklet was also measured.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • A common monoradicular sciatica on a slipped disc with a clinical radio agreement requiring a surgical treatment, after failure of an good ambulatory treatment carried out, one duration of evolution higher than four weeks at naive subjects of any rachidian intervention

排除标准

  • People presenting a cruralgia, a secondary sciatica (epiduritis, osseous metastasis...) or without relationship with a slipped disc (spinal stenosis), an lesion biradicular, an horse tail syndrome, an important motor deficit (muscular testing < 3)
  • Cognitive, auditive, major visual disorders or any subject which does not have a good comprehension of spoken French and/or writing, or having recourse to a third for reading and supplementing a document
  • Subjects presenting a peripheral neuropathy, a severe and evolved diabetes, a cardiac insufficiency, dialysed subject
  • People observing a treatment which included psychotropics for more than three months (other that light hypnotic) because of the disturbances of vigilance and memory

结局指标

主要结局

Quebec Questionnaire

时间窗: after lumbar discectomy

次要结局

  • FABQ Questionnaire(after lumbar discectomy)
  • Rachidian and radicular painful intensity(after lumbar discectomy)

研究者

发起方
University Hospital, Clermont-Ferrand
申办方类型
Other

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