DISCO - Influence of a Simple Information Booklet on the... | NCT00343057

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

NCT00343057

Sponsor

Sanofi

Status

Completed

Last Update Posted

Sep 4, 2009Estimated

Enrollment

2,830Actual

Phase

Not provided

Conditions

Acute Low Back Pain

Interventions

Patients' questionnaire

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2003

Primary Completion Date

Not provided

Completion Date

Jun 2004Actual

First Submitted Date

Jun 20, 2006

First Submission Date that Met QC Criteria

Jun 21, 2006

First Posted Date

Jun 22, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 3, 2009

Last Update Posted Date

Sep 4, 2009Estimated

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

2,830Actual

Name	Type	Description	Arm Group Labels	Other Names
Patients' questionnaire	Other

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Subjects presenting with acute common low back pain.

Sampling Method

Probability Sample

Name	Affiliation	Role
COUDERC, Dr	Sanofi	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17684553	Derived	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.