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OpenTrials
Completed

NCT Number: NCT00343057

DISCO - Influence of a Simple Information Booklet on the Evolution of Acute Low Back Pain (LBP)

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

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sanofi-Aventis

Paris, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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.

Treatment and study plan

Patients' questionnaire

Other

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

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

Important dates

Study start
2003
Study completion
2004
First posted
Jun 22, 2006
Registry last updated
Sep 4, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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