Acute Low Back PainNCT00343057
DISCO - Influence of a Simple Information Booklet on the Evolution of Acute Low Back Pain (LBP)
An observational study of Acute Low Back Pain, run by Sanofi at 1 site in France.
Trial summary
To assess the impact of standardized written information on outcome in acute LBP. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Low Back Pain
- What is being tested?
- Patients' questionnaire
- How many people
- 2,830 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2003to Jun 2004
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects presenting with acute common low back pain.
Who may be able to join
- Each GP have to enroll up to 4 patients with acute LBP.
Who cannot join
- 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;
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
To assess the impact of standardized written information on outcome in acute LBP.
Read the 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.
- Conditions
- Acute Low Back Pain
- Being tested
- Patients' questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients' questionnaireOther
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2006 (estimated)
- Study startSep 2003
- Study completionJun 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Low Back PainStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 2,830 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- COUDERC, Dr, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00343057
- Sponsor's protocol ID
- IXP0001A_9001
- Status last verified
- Sep 2009
- First submitted
- 20 Jun 2006
- Last updated
- 4 Sep 2009
- Results posted
- No
Publications
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.
PubMed 17684553
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00343057
- Acronym / sponsor ID
- IXP0001A_9001
- Conditions
- Acute Low Back Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,830 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Sep 2003
- Study completion
- Jun 2004 (actual)
- First posted
- 22 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects presenting with acute common low back pain.
Key inclusion criteria (1 listed)
- Each GP have to enroll up to 4 patients with acute LBP.
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patients' questionnaire | Other | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2009.
- Derived from this study: PubMed 17684553Coudeyre 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
COUDERC, Dr study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Low Back Pain, run by Sanofi at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00343057, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2009.