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临床试验/NCT00343057
NCT00343057已完成不适用

Influence of a Simple Information Booklet on the Evolution of Acute Low Back Pain (LBP): a Quasi-experimental Study in a Primary Care Setting.

Sanofi1 个研究点 分布在 1 个国家目标入组 2,830 人开始时间: 2003年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Sanofi
入组人数
2,830
试验地点
1

研究概览

简要总结

To assess the impact of standardized written information on outcome in acute LBP.

详细描述

A 3-month prospective, controlled study with a quasi-experimental design (i.e., a nonrandomized controlled sample with geographic stratification [30 areas]). Control and intervention areas ARE selected for their similarities in rural-to-urban distribution of the population and patients' access to GPs and to minimize risk of overlap between areas.

研究设计

研究类型
Observational

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

  • Each GP have to enroll up to 4 patients with acute LBP.

排除标准

  • Patients are excluded if they
  • are less than 18 years old;
  • have pain for more than 4 weeks;
  • have pain intensity for the previous 24 hours less than 3 on a 11-point numeric scale (0= no pain, 10=maximal pain);
  • have sciatica;
  • have had a previous episode of acute LBP during the last 12 months;
  • have no occupational activities;
  • have consulted another practitioner for the same episode of back pain;
  • are pregnant;
  • have back pain related to infection, tumor, or inflammatory disease; or (j) have previously undergone back surgery.
  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

研究者

发起方
Sanofi
申办方类型
Industry

研究点 (1)

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