Status:
COMPLETED
DISCO - Influence of a Simple Information Booklet on the Evolution of Acute Low Back Pain (LBP)
Lead Sponsor:
Sanofi
Conditions:
Acute Low Back Pain
Eligibility:
All Genders
18+ years
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 selec...
Eligibility Criteria
Inclusion
- Each GP have to enroll up to 4 patients with acute LBP.
Exclusion
- 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.
Key Trial Info
Start Date :
September 1 2003
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2004
Estimated Enrollment :
2830 Patients enrolled
Trial Details
Trial ID
NCT00343057
Start Date
September 1 2003
End Date
June 1 2004
Last Update
September 4 2009
Active Locations (1)
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1
Sanofi-Aventis
Paris, France