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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00343057
First received: June 20, 2006
Last updated: September 3, 2009
Last verified: September 2009
  Purpose

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


Condition Intervention
Acute Low Back Pain
Other: Patients' questionnaire

Study Type: Observational
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.

Resource links provided by NLM:


Further study details as provided by Sanofi:

Enrollment: 2830
Study Start Date: September 2003
Study Completion Date: June 2004
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Subjects presenting with acute common low back pain.

Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00343057

Locations
France
Sanofi-Aventis
Paris, France
Sponsors and Collaborators
Sanofi
Investigators
Study Director: COUDERC, Dr Sanofi
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00343057     History of Changes
Other Study ID Numbers: IXP0001A_9001
Study First Received: June 20, 2006
Last Updated: September 3, 2009
Health Authority: France : Not applicable

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on October 30, 2014