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

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00343057
• Other study ID #: IXP0001A_9001
• Status: Completed
• Phase: N/A
• First received: June 20, 2006
• Last updated: September 3, 2009
• Start date: September 2003
• Est. completion date: June 2004

Study information

• Verified date: September 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: France : Not applicable
• Study type: Observational

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 2830
• Est. completion date: June 2004
• 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.

Study Design

N/A

Related Conditions & MeSH terms

• Acute Low Back Pain
• Back Pain
• Low Back Pain

Intervention

Other:
• Patients' questionnaire

Locations

Country	Name	City	State
France	Sanofi-Aventis	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

France,