Acute Low Back Pain Clinical Trial
Official 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.
Verified date | September 2009 |
Source | Sanofi |
Contact | n/a |
Is FDA regulated | No |
Health authority | France : Not applicable |
Study type | Observational |
To assess the impact of standardized written information on outcome in acute LBP.
Status | Completed |
Enrollment | 2830 |
Est. completion date | June 2004 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
N/A
Country | Name | City | State |
---|---|---|---|
France | Sanofi-Aventis | Paris |
Lead Sponsor | Collaborator |
---|---|
Sanofi |
France,
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