Back to resultsDISCO - Influence of a Simple Information Booklet on the Evolution of Acute Low Back Pain (LBP)
Primary Purpose
Acute Low Back Pain
Status
Completed
Phase
Locations
France
Study Type
Observational
Intervention
Patients' questionnaire
Sponsored by
About this trial
This is an observational trial for Acute Low Back Pain
Eligibility Criteria
Inclusion Criteria: Each GP have to enroll up to 4 patients with acute LBP. Exclusion Criteria: Patients are excluded if they are less than 18 years old; have pain for more than 4 weeks; have pain intensity for the previous 24 hours less than 3 on a 11-point numeric scale (0= no pain, 10=maximal pain); have sciatica; have had a previous episode of acute LBP during the last 12 months; have no occupational activities; have consulted another practitioner for the same episode of back pain; are pregnant; 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.
Sites / Locations
- Sanofi-Aventis
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00343057
Brief Title
DISCO - Influence of a Simple Information Booklet on the Evolution of Acute Low Back Pain (LBP)
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 Type
Observational
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sanofi
4. Oversight
5. Study Description
Brief Summary
To assess the impact of standardized written information on outcome in acute LBP.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Low Back Pain
7. Study Design
Enrollment
2830 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
Patients' questionnaire
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Each GP have to enroll up to 4 patients with acute LBP.
Exclusion Criteria:
Patients are excluded if they
are less than 18 years old;
have pain for more than 4 weeks;
have pain intensity for the previous 24 hours less than 3 on a 11-point numeric scale (0= no pain, 10=maximal pain);
have sciatica;
have had a previous episode of acute LBP during the last 12 months;
have no occupational activities;
have consulted another practitioner for the same episode of back pain;
are pregnant;
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 Population Description
Subjects presenting with acute common low back pain.
Sampling Method
Probability Sample
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
COUDERC, Dr
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis
City
Paris
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
17684553
Citation
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.
Results Reference
derived
Learn more about this trial
DISCO - Influence of a Simple Information Booklet on the Evolution of Acute Low Back Pain (LBP)
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