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

Influence of a Simple Information Booklet on the Evolution of Acute Low Back Pain (LBP): a Quasi-experimental Study in a Primary Care Setting.

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

Study Overview

• Status: Completed
• Conditions: Acute Low Back Pain
• Intervention / Treatment: Other: Patients' questionnaire

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.

• Study Type: Observational
• Enrollment (Actual): 2830

Contacts and Locations

Study Locations

• France
  • Paris, France
    • Sanofi-Aventis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Subjects presenting with acute common low back pain.

Description

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 Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: Sanofi
• Investigators: Study Director: COUDERC, Dr, Sanofi

Publications and helpful links

General Publications

• Coudeyre E, Tubach F, Rannou F, Baron G, Coriat F, Brin S, Revel M, Poiraudeau S. Effect of a simple information booklet on pain persistence after an acute episode of low back pain: a non-randomized trial in a primary care setting. PLoS One. 2007 Aug 8;2(8):e706. doi: 10.1371/journal.pone.0000706.

Study record dates

Study Major Dates

• Study Start: September 1, 2003
• Study Completion (Actual): June 1, 2004

Study Registration Dates

• First Submitted: June 20, 2006
• First Submitted That Met QC Criteria: June 21, 2006
• First Posted (Estimate): June 22, 2006

Study Record Updates

• Last Update Posted (Estimate): September 4, 2009
• Last Update Submitted That Met QC Criteria: September 3, 2009
• Last Verified: September 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: IXP0001A_9001