NCT00343057

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,830

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2003

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2004

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

June 20, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 22, 2006

Completed
Last Updated

September 4, 2009

Status Verified

September 1, 2009

First QC Date

June 20, 2006

Last Update Submit

September 3, 2009

Conditions

Acute Low Back Pain

Interventions

Patients' questionnaireOTHER

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Subjects presenting with acute common low back pain.

You may qualify if:

  • Each GP have to enroll up to 4 patients with acute LBP.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanofi-Aventis

Paris, France

Location

Related Publications (1)

  • 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.

    PMID: 17684553DERIVED

Study Officials

  • COUDERC, Dr

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
observational
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 20, 2006

First Posted

June 22, 2006

Study Start

September 1, 2003

Study Completion

June 1, 2004

Last Updated

September 4, 2009

Record last verified: 2009-09

Locations

FR(1)