DISCO - Influence of a Simple Information Booklet on the Evolution of Acute Low Back Pain (LBP)
Completed
- Conditions
- Acute Low Back Pain
- Registration Number
- NCT00343057
- Lead Sponsor
- Sanofi
- Brief Summary
To assess the impact of standardized written information on outcome in acute LBP.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2830
Inclusion Criteria
- Each GP have to enroll up to 4 patients with acute LBP.
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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.
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Sanofi-Aventis
🇫🇷Paris, France