Acute Low Back PainAcuteLBPNCT04575714
Clinical Pathways and Patients' Attitudes in Acute Low Back Pain
An observational study of Acute Low Back Pain, run by CHU de Reims at 1 site in France.
Trial summary
In France the prevalence of low back pain is 70 to 80 %. It's the leading cause of health expenditure in Europe and costs 900 million euros per year to health insurance in France. This is the second reason to consult a general practitioner. Acute low back pain is defined as low back pain lasts less than 6 weeks. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Low Back Pain
- What is being tested?
- Data record
- How many people
- 250 participants
- Where
- 1 siteFrance
- Study dates
- 19 Jul 2019to 19 Nov 2019
- 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 to 65 years
- All sexes
- Adult, Older adult
Study population: Patients between 18 and 65 years old living in France to have ever had an acute low back pain
Who may be able to join
- men and women
- aged between 18 and 65 years old
- living in France
- to have ever had an acute low back pain
- accepting to participate in the study
Who cannot join
- over 65 or under 18 years old
Trial locations and contacts
1 site in 1 country.
About this study
In France the prevalence of low back pain is 70 to 80 %. It's the leading cause of health expenditure in Europe and costs 900 million euros per year to health insurance in France. This is the second reason to consult a general practitioner. Acute low back pain is defined as low back pain lasts less than 6 weeks. It represents 60 to 70 % of low back pain but only 20% of the costs induced by low back pain in general. In fact, acute low back pain often heals spontaneously.
Risk factors for acute low back pain and risk factors for chronic low back pain have been the subject of many publications. They remain very difficult to prevent in practice because of their multiplicity. Preventing acute low back pain is part of the prevention of chronic low back pain. Patient care management of low back pain is well codified and consensual in the various international recommendations. However, their application is sometimes very disparate and bad habits on both patients and professionals persist. Advices recommended in the case of low back pain are widely disseminated but their applications are little studied. In 2017, in France, health insurance started a "back pain" prevention campaign with the objective of raising awareness of good attitudes in the event of back pain. It made an initial assessment of the different knowledges concerning spinal pain in the general population but also in the medical population with the aim of improving them. It appears that number of patients would not consult physician in this case. The many proposals of care and the diversity of medical professionals, paramedics and other stakeholders, proposing to cure low back pain form as many different clinical pathways. Use of alternative or unconventional medicines is poorly assessed. In this context, it seems relevant to evaluate patient clinical pathways and patients' attitudes.
Read the detailed description
The aim of the study is to explore patient clinical pathways and patients' attitudes in acute low back pain
- Conditions
- Acute Low Back Pain
- Being tested
- Data record
- Keywords
- Acute low back pain, low back pain, clinical pathway
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data recordOther
Data record
| Study group | Role | What they receive |
|---|---|---|
| Acute low back pain | Adult patients with acute low back pain Receives: Other: Data record |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical pathways
First professional consulted by patients : general practitioner or specialist
Measured: Day 0
Secondary outcomes (1)
patients' attitude
patient's first attitude: stop or continue physical activity
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start19 Jul 2019
- Primary completion19 Nov 2019
- Study completion19 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Low Back PainStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe 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
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04575714
- Sponsor's protocol ID
- PO19084
- Acronym
- AcuteLBP
- Status last verified
- Sep 2020
- First submitted
- 29 Sep 2020
- Last updated
- 5 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Pathways and Patients' Attitudes in Acute Low Back Pain
- ClinicalTrials.gov ID
- NCT04575714
- Acronym / sponsor ID
- AcuteLBP / PO19084
- Conditions
- Acute Low Back Pain
- Keywords
- Acute low back pain, low back pain, clinical pathway
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 19 Jul 2019 (actual)
- Primary completion
- 19 Nov 2019 (actual)
- Study completion
- 19 Nov 2019 (actual)
- First posted
- 5 Oct 2020 (actual)
- 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.
In France the prevalence of low back pain is 70 to 80 %. It's the leading cause of health expenditure in Europe and costs 900 million euros per year to health insurance in France. This is the second reason to consult a general practitioner. Acute low back pain is defined as low back pain lasts less than 6 weeks. It represents 60 to 70 % of low back pain but only 20% of the costs induced by low back pain in general. In fact, acute low back pain often heals spontaneously.
Risk factors for acute low back pain and risk factors for chronic low back pain have been the subject of many publications. They remain very difficult to prevent in practice because of their multiplicity. Preventing acute low back pain is part of the prevention of chronic low back pain. Patient care management of low back pain is well codified and consensual in the various international recommendations. However, their application is sometimes very disparate and bad habits on both patients and professionals persist. Advices recommended in the case of low back pain are widely disseminated but their applications are little studied. In 2017, in France, health insurance started a "back pain" prevention campaign with the objective of raising awareness of good attitudes in the event of back pain. It made an initial assessment of the different knowledges concerning spinal pain in the general population but also in the medical population with the aim of improving them. It appears that number of patients would not consult physician in this case. The many proposals of care and the diversity of medical professionals, paramedics and other stakeholders, proposing to cure low back pain form as many different clinical pathways. Use of alternative or unconventional medicines is poorly assessed. In this context, it seems relevant to evaluate patient clinical pathways and patients' attitudes.
Detailed description
The aim of the study is to explore patient clinical pathways and patients' attitudes in acute low back pain
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute low back pain | – | Other: Data recordAdult patients with acute low back pain |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients between 18 and 65 years old living in France to have ever had an acute low back pain
Key inclusion criteria (5 listed)
- men and women
- aged between 18 and 65 years old
- living in France
- to have ever had an acute low back pain
- accepting to participate in the study
Key exclusion criteria (1 listed)
- over 65 or under 18 years old
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 |
|---|---|---|
| Data recordData record | Other | Acute low back pain |
Primary outcome
clinical pathways
Time frame: Day 0
First professional consulted by patients : general practitioner or specialist
1 secondary outcome
patients' attitude
Time frame: Day 0
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 5 Oct 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 CHU de Reims 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 5 inclusion and 1 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 5 Oct 2020. 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.
What does the primary outcome measure?
clinical pathways (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Oct 2020.