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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00343057
Recruitment Status : Completed
First Posted : June 22, 2006
Last Update Posted : September 4, 2009
Information provided by:

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

Condition or disease Intervention/treatment
Acute Low Back Pain 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
Actual Enrollment : 2830 participants
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.
Study Start Date : September 2003
Actual Study Completion Date : June 2004

Resource links provided by the National Library of Medicine

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Subjects presenting with acute common low back pain.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00343057

Paris, France
Sponsors and Collaborators
Study Director: COUDERC, Dr Sanofi

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00343057     History of Changes
Other Study ID Numbers: IXP0001A_9001
First Posted: June 22, 2006    Key Record Dates
Last Update Posted: September 4, 2009
Last Verified: September 2009

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