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

Sanofi2,830 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

2,830

Conditions

Acute Low Back Pain

Interventions

Patients' questionnaireOTHER

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Each GP have to enroll up to 4 patients with acute LBP. Exclusion Criteria: Patients are excluded if they 1. are less than 18 years old; 2. have pain for more than 4 weeks; 3. have pain intensity for the previous 24 hours less than 3 on a 11-point numeric scale (0= no pain, 10=maximal pain); 4. have sciatica; 5. have had a previous episode of acute LBP during the last 12 months; 6. have no occupational activities; 7. have consulted another practitioner for the same episode of back pain; 8. are pregnant; 9. 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.

Locations (1)

Sanofi-Aventis

Paris, France

Data from ClinicalTrials.gov

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