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

Sanofi

Status: Completed

Conditions: Acute Low Back Pain

Treatments: Other: Patients' questionnaire

Study type: Observational

Funder types: Industry

Identifiers

NCT00343057

IXP0001A_9001

Details and patient eligibility

About

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

Full 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.

Enrollment: 2,830 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.