Text Size

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
History of Changes
  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:

MedlinePlus related topics: Back Pain
U.S. FDA Resources

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
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
Pain
 Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013