Low Back PainNCT03953625
Interest of the Return to Primary Care of the "Low Back Pain Booklet" of Health Insurance in the Recovery of Common Acute Low Back Pain
A study testing delivery of the low back pain booklet in people with Low Back Pain, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
Low back pain is defined as pain or functional discomfort between the twelfth rib and the gluteal fold, which may be median or lateralised. It can radiate up to the thigh but never below the knee. Low back pain is said to be acute if it has been progressing for less than three months. Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- delivery of the low back pain booklet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteFrance
- Study dates
- 29 Nov 2018to 26 Oct 2021
- Phase
- Interventional
- 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 20 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient aged 20 to 55 years old
- Presenting an episode of acute common low back pain diagnosed in the GHPSJ emergency room or in general medical consultation at the CMT, evolving for less than 72 hours
- Capable of giving free, informed and express consent
Who cannot join
- Existence of underlying chronic low back pain
- Associated radiculalgia descending below the knee
- Specific low back pain (with a "red flag")
- Patient not reading or understanding French
- Patient deprived of liberty
- Patient under guardianship or curatorship
- Patient under the protection of justice
Trial locations and contacts
1 site in 1 country.
France1 site
Groupe Hospitalier Paris Saint Joseph
Paris, Île-de-France Region, 75014
About this study
Official title: Interest of the Return to Primary Care of the "Low Back Booklet" of Health Insurance in the Recovery of Common Acute Low Back Pain
Low back pain is defined as pain or functional discomfort between the twelfth rib and the gluteal fold, which may be median or lateralised. It can radiate up to the thigh but never below the knee. Low back pain is said to be acute if it has been progressing for less than three months. In the acute form, it evolves on a mechanical rhythm, prevents the usual activity and occurs preferably in adults aged 20 to 55 years. 90% of these low back pains are mechanical and common, i.e. characterized by the absence of "red flags ". The red flags refer to a group of characteristic clinical signs that should alert the practitioner to the possibility of an underlying serious spinal pathology and the need for further investigation.
Common low back pain is a public health issue since it is the leading cause of health expenditure in Europe and an economic challenge (900 million euros / year and 19.1% of work stoppages in 2015 compared to 13% in 2005).
Read more
In 80% of cases, the general practitioner is in the first line of care in cases of acute low back pain. Indeed, it represents a frequent reason for consultation in general medicine (2nd reason for consultation among general practitioners in 2015).
The doctor must: track down warning signs that call into question the diagnosis of common low back pain (red flags), relieve and reassure the patient. Common low back pain very often heals spontaneously but about 10% of patients will develop chronic low back pain (persistence of pain for more than 3 months). These chronicized patients account for 80% of the total cost of low back pain.
Read the detailed description
According Paracetamol is often insufficient and it is necessary to switch to level 2 analgesics (tramadol, codeine). NSAIDs are used in short courses.
It is crucial to reassure the patient about the benign nature of the condition and to insist on maintaining activities. Bed rest should never be recommended, let alone prescribed. The usual activities of daily living should be maintained as much as possible within the limits allowed by pain. A work stoppage may be considered if the professional constraints are greater than those of daily life. The return to work has no deleterious effect and must be as early as possible.
It is useful to detect early chronicization factors, especially psychosocial ones. Finally, in order to prevent lumbar disability, patient education, based on the bio-psycho-social model, must be an important part of patient care. The content of the physician's speech strongly influences the patient's beliefs and behaviour. However, if the information can be provided by the therapist, it can also be provided via brochures.
This is why the Health Insurance launched a public information campaign in November 2017 to improve the management of low back therapeutic education, pain, spine sections], the French Society of Rheumatologyk pain. The French Society of Rheumatology, The French Society of Rheumatology, therapeutic education, pain, spine sections], the French Society of Rheumatology physical and rehabilitation medicine and the college of general medicine have worked together to publish a "booklet back": I suffer from low back pain: what is it and what to do? whose main objective is to fight against false beliefs concerning inter alia "the benefits of strict rest", to promote physical activity, and to recall the true indications of complementary examinations (radiography, CT, or MRI of the spine) Thus, the back booklet intended for the patient is distributed to general practitioners via the visits of the delegates of the Health Insurance. Nearly 1,600,000 brochures were printed and made available to delegates for distribution to health professionals, with 30 brochures per general practitioner. The brochure is also available for download on ameli.fr in the "insured" and "health professionals" sections (doctors, physiotherapists, care institutions, health centres). In this study, one of the 2 participating centres is the Groupe Hospitalier Paris Saint Joseph (GHPSJ), emergency department. Also, we contacted the health insurance to receive brochures. To our knowledge, there is no other emergency service that has done this. The 2nd service centre participating in the study is the general practitioner consultation centre at the Marie-Thérèse health centre (CMT).
- Conditions
- Low Back Pain
- Being tested
- delivery of the low back pain booklet
- Keywords
- Common Acute Low Back Pain, Low Back Pain Booklet, Health Insurance
- 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.
delivery of the low back pain bookletOther
When a patient arrives at the GHPSJ emergency room or in general medical consultation at the CMT and a diagnosis of common acute low back pain is made, the physician verifies the study selection criteria.
If it is randomized in the arm 2 "with booklet" group, the management will be the same as for the "without booklet" group but with the hand delivery of the booklet in addition.
All patients will be informed about the existence of the booklet. A link to the digital version on the ameli.fr website is included in the information note The patient will be contacted 3 months later by a Clinical Research Associate (CRA) to conduct a data collection.
| Study group | Role | What they receive |
|---|---|---|
| no delivery of the low back pain booklet | No intervention | When a patient arrives at the GHPSJ emergency room or in general medical consultation at the CMT and a diagnosis of common acute low back pain is made, the physician verifies the study selection criteria. if the patient is included and depending on the week of inclusion, he will then be randomized to either the "no booklet" or the "booklet" group. If it is randomized to the arm 1 "no booklet" group, the patient will have classic management. All patients will be informed about the existence of the booklet. A link to the digital version on the ameli.fr website is included in the information note The patient will be contacted 3 months later by a Clinical Research Associate (CRA) to conduct a data collection. |
| delivery of the low back pain booklet | Experimental | When a patient arrives at the GHPSJ emergency room or in general medical consultation at the CMT and a diagnosis of common acute low back pain is made, the physician verifies the study selection criteria.
If the patient is included and depending on the week of inclusion, the patient will then be randomized to either the "no booklet" or the "booklet" group.
If it is randomized in the arm 2 "with booklet" group, the management will be the same as for the "without booklet" group but with the hand delivery of the booklet in addition.
All patients will be informed about the existence of the booklet. A link to the digital version on the ameli.fr website is included in the information note The patient will be contacted 3 months later by a Clinical Research Associate (CRA) to conduct a data collection. Receives: Other: delivery of the low back pain booklet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in the evolution of the EIFEL score at 3 months after inclusion between the 2 patient groups
A difference of 5 points in the EIFEL score between the two groups, already validated in previous studies, will be considered clinically significant.
Measured: 3 months after inclusion
Secondary outcomes (13)
Percentage of patients who have read the booklet
Differences between the 2 groups at 3 months
Measured: 3 months after inclusion
Percentage of patients who consulted the booklet on the ameli.fr website
Differences between the 2 groups at 3 months
Measured: 3 months after inclusion
Percentage of patients who have resumed or started physical activity as recommended in the booklet
Differences between the 2 groups at 3 months
Measured: 3 months after inclusion
Percentage of patients performing the recommended exercises
Differences between the 2 groups at 3 months
Measured: 3 months after inclusion
Percentage of patients still suffering from low back pain (defined by the persistence of back pain)
Differences between the 2 groups at 3 months
Measured: 3 months after inclusion
Numerical scale evaluating the pain
Intensity of lumbar pain experienced over the last 72 hours evaluated on a numerical scale (from 0 to 10) for patients still suffering from low back pain Differences between the 2 groups at 3 months
Measured: 3 months after inclusion
Duration of evolution of the initial low back pain episode if resolving
Differences between the 2 groups at 3 months
Measured: 3 months after inclusion
Duration of any work stoppage related to low back pain
Differences between the 2 groups at 3 months
Measured: 3 months after inclusion
Number of medical consultations
Differences between the 2 groups at 3 months
Measured: 3 months after inclusion
Number of physiotherapy or osteopathy sessions
Differences between the 2 groups at 3 months
Measured: 3 months after inclusion
Number of additional examinations
Differences between the 2 groups at 3 months
Measured: 3 months after inclusion
Number of analgesics taken per day during the last 72 hours (classified by WHO levels)
Differences between the 2 groups at 3 months
Measured: 3 months after inclusion
Satisfaction with the information given about the booklet
Numerical scale (from 0 to 10) Differences between the 2 groups at 3 months
Measured: 3 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2019
- Study start29 Nov 2018
- Primary completion13 May 2020
- Study completion26 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- D'USSEL Marguerite, MD, Principal investigator, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03953625
- Sponsor's protocol ID
- Livret lombalgie
- Status last verified
- Mar 2022
- First submitted
- 15 May 2019
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Greenhalgh S, Selfe J. A qualitative investigation of Red Flags for serious spinal pathology. Physiotherapy. 2009 Sep;95(3):224-7. doi: 10.1016/j.physio.2009.04.006. Epub 2009 Jul 8. No abstract available.
PubMed 19635343Nicholas MK, Linton SJ, Watson PJ, Main CJ; "Decade of the Flags" Working Group. Early identification and management of psychological risk factors ("yellow flags") in patients with low back pain: a reappraisal. Phys Ther. 2011 May;91(5):737-53. doi: 10.2522/ptj.20100224. Epub 2011 Mar 30.
PubMed 21451099Bishop A, Foster NE, Thomas E, Hay EM. How does the self-reported clinical management of patients with low back pain relate to the attitudes and beliefs of health care practitioners? A survey of UK general practitioners and physiotherapists. Pain. 2008 Mar;135(1-2):187-95. doi: 10.1016/j.pain.2007.11.010.
PubMed 18206309Friedman BW, Irizarry E, Solorzano C, Khankel N, Zapata J, Zias E, Gallagher EJ. Diazepam Is No Better Than Placebo When Added to Naproxen for Acute Low Back Pain. Ann Emerg Med. 2017 Aug;70(2):169-176.e1. doi: 10.1016/j.annemergmed.2016.10.002. Epub 2017 Feb 7.
PubMed 28187918Friedman BW, Dym AA, Davitt M, Holden L, Solorzano C, Esses D, Bijur PE, Gallagher EJ. Naproxen With Cyclobenzaprine, Oxycodone/Acetaminophen, or Placebo for Treating Acute Low Back Pain: A Randomized Clinical Trial. JAMA. 2015 Oct 20;314(15):1572-80. doi: 10.1001/jama.2015.13043.
PubMed 26501533Coste J, Le Parc JM, Berge E, Delecoeuillerie G, Paolaggi JB. [French validation of a disability rating scale for the evaluation of low back pain (EIFEL questionnaire)]. Rev Rhum Ed Fr. 1993 May;60(5):335-41. French.
PubMed 8167640Roland M, Morris R. A study of the natural history of back pain. Part I: development of a reliable and sensitive measure of disability in low-back pain. Spine (Phila Pa 1976). 1983 Mar;8(2):141-4. doi: 10.1097/00007632-198303000-00004. No abstract available.
PubMed 6222486
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of the Return to Primary Care of the "Low Back Booklet" of Health Insurance in the Recovery of Common Acute Low Back Pain
- ClinicalTrials.gov ID
- NCT03953625
- Acronym / sponsor ID
- Livret lombalgie
- Conditions
- Low Back Pain
- Keywords
- Common Acute Low Back Pain, Low Back Pain Booklet, Health Insurance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 29 Nov 2018 (actual)
- Primary completion
- 13 May 2020 (actual)
- Study completion
- 26 Oct 2021 (actual)
- First posted
- 16 May 2019 (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.
Low back pain is defined as pain or functional discomfort between the twelfth rib and the gluteal fold, which may be median or lateralised. It can radiate up to the thigh but never below the knee. Low back pain is said to be acute if it has been progressing for less than three months. In the acute form, it evolves on a mechanical rhythm, prevents the usual activity and occurs preferably in adults aged 20 to 55 years. 90% of these low back pains are mechanical and common, i.e. characterized by the absence of "red flags ". The red flags refer to a group of characteristic clinical signs that should alert the practitioner to the possibility of an underlying serious spinal pathology and the need for further investigation.
Common low back pain is a public health issue since it is the leading cause of health expenditure in Europe and an economic challenge (900 million euros / year and 19.1% of work stoppages in 2015 compared to 13% in 2005).
In 80% of cases, the general practitioner is in the first line of care in cases of acute low back pain. Indeed, it represents a frequent reason for consultation in general medicine (2nd reason for consultation among general practitioners in 2015).
The doctor must: track down warning signs that call into question the diagnosis of common low back pain (red flags), relieve and reassure the patient. Common low back pain very often heals spontaneously but about 10% of patients will develop chronic low back pain (persistence of pain for more than 3 months). These chronicized patients account for 80% of the total cost of low back pain.
Detailed description
According Paracetamol is often insufficient and it is necessary to switch to level 2 analgesics (tramadol, codeine). NSAIDs are used in short courses.
It is crucial to reassure the patient about the benign nature of the condition and to insist on maintaining activities. Bed rest should never be recommended, let alone prescribed. The usual activities of daily living should be maintained as much as possible within the limits allowed by pain. A work stoppage may be considered if the professional constraints are greater than those of daily life. The return to work has no deleterious effect and must be as early as possible.
It is useful to detect early chronicization factors, especially psychosocial ones. Finally, in order to prevent lumbar disability, patient education, based on the bio-psycho-social model, must be an important part of patient care. The content of the physician's speech strongly influences the patient's beliefs and behaviour. However, if the information can be provided by the therapist, it can also be provided via brochures.
This is why the Health Insurance launched a public information campaign in November 2017 to improve the management of low back therapeutic education, pain, spine sections], the French Society of Rheumatologyk pain. The French Society of Rheumatology, The French Society of Rheumatology, therapeutic education, pain, spine sections], the French Society of Rheumatology physical and rehabilitation medicine and the college of general medicine have worked together to publish a "booklet back": I suffer from low back pain: what is it and what to do? whose main objective is to fight against false beliefs concerning inter alia "the benefits of strict rest", to promote physical activity, and to recall the true indications of complementary examinations (radiography, CT, or MRI of the spine) Thus, the back booklet intended for the patient is distributed to general practitioners via the visits of the delegates of the Health Insurance. Nearly 1,600,000 brochures were printed and made available to delegates for distribution to health professionals, with 30 brochures per general practitioner. The brochure is also available for download on ameli.fr in the "insured" and "health professionals" sections (doctors, physiotherapists, care institutions, health centres). In this study, one of the 2 participating centres is the Groupe Hospitalier Paris Saint Joseph (GHPSJ), emergency department. Also, we contacted the health insurance to receive brochures. To our knowledge, there is no other emergency service that has done this. The 2nd service centre participating in the study is the general practitioner consultation centre at the Marie-Thérèse health centre (CMT).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| no delivery of the low back pain booklet | No intervention | –When a patient arrives at the GHPSJ emergency room or in general medical consultation at the CMT and a diagnosis of common acute low back pain is made, the physician verifies the study selection criteria. if the patient is included and depending on the week of inclusion, he will then be randomized to either the "no booklet" or the "booklet" group. If it is randomized to the arm 1 "no booklet" group, the patient will have classic management. All patients will be informed about the existence of the booklet. A link to the digital version on the ameli.fr website is included in the information note The patient will be contacted 3 months later by a Clinical Research Associate (CRA) to conduct a data collection. |
| delivery of the low back pain booklet | Experimental | Other: delivery of the low back pain bookletWhen a patient arrives at the GHPSJ emergency room or in general medical consultation at the CMT and a diagnosis of common acute low back pain is made, the physician verifies the study selection criteria. If the patient is included and depending on the week of inclusion, the patient will then be randomized to either the "no booklet" or the "booklet" group. If it is randomized in the arm 2 "with booklet" group, the management will be the same as for the "without booklet" group but with the hand delivery of the booklet in addition. All patients will be informed about the existence of the booklet. A link to the digital version on the ameli.fr website is included in the information note The patient will be contacted 3 months later by a Clinical Research Associate (CRA) to conduct a data collection. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patient aged 20 to 55 years old
- Presenting an episode of acute common low back pain diagnosed in the GHPSJ emergency room or in general medical consultation at the CMT, evolving for less than 72 hours
- Capable of giving free, informed and express consent
Key exclusion criteria (7 listed)
- Existence of underlying chronic low back pain
- Associated radiculalgia descending below the knee
- Specific low back pain (with a "red flag")
- Patient not reading or understanding French
- Patient deprived of liberty
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 |
|---|---|---|
| delivery of the low back pain bookletWhen a patient arrives at the GHPSJ emergency room or in general medical consultation at the CMT and a diagnosis of common acute low back pain is made, the physician verifies the study selection criteria. If it is randomized in the arm 2 "with booklet" group, the management will be the same as for the "without booklet" group but with the hand delivery of the booklet in addition. All patients will be informed about the existence of the booklet. A link to the digital version on the ameli.fr website is included in the information note The patient will be contacted 3 months later by a Clinical Research Associate (CRA) to conduct a data collection. | Other | delivery of the low back pain booklet |
Primary outcome
Difference in the evolution of the EIFEL score at 3 months after inclusion between the 2 patient groups
Time frame: 3 months after inclusion
A difference of 5 points in the EIFEL score between the two groups, already validated in previous studies, will be considered clinically significant.
13 secondary outcomes
Percentage of patients who have read the booklet
Time frame: 3 months after inclusion
Percentage of patients who consulted the booklet on the ameli.fr website
Time frame: 3 months after inclusion
Percentage of patients who have resumed or started physical activity as recommended in the booklet
Time frame: 3 months after inclusion
Percentage of patients performing the recommended exercises
Time frame: 3 months after inclusion
Percentage of patients still suffering from low back pain (defined by the persistence of back pain)
Time frame: 3 months after inclusion
Numerical scale evaluating the pain
Time frame: 3 months after inclusion
Duration of evolution of the initial low back pain episode if resolving
Time frame: 3 months after inclusion
Duration of any work stoppage related to low back pain
Time frame: 3 months after inclusion
Number of medical consultations
Time frame: 3 months after inclusion
Number of physiotherapy or osteopathy sessions
Time frame: 3 months after inclusion
Number of additional examinations
Time frame: 3 months after inclusion
Number of analgesics taken per day during the last 72 hours (classified by WHO levels)
Time frame: 3 months after inclusion
Satisfaction with the information given about the booklet
Time frame: 3 months after inclusion
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 31 Mar 2022.
- Results publication: PubMed 19635343Greenhalgh S, Selfe J. A qualitative investigation of Red Flags for serious spinal pathology. Physiotherapy. 2009 Sep;95(3):224-7. doi: 10.1016/j.physio.2009.04.006. Epub 2009 Jul 8. No abstract available.
- Results publication: PubMed 21451099Nicholas MK, Linton SJ, Watson PJ, Main CJ; "Decade of the Flags" Working Group. Early identification and management of psychological risk factors ("yellow flags") in patients with low back pain: a reappraisal. Phys Ther. 2011 May;91(5):737-53. doi: 10.2522/ptj.20100224. Epub 2011 Mar 30.
- Results publication: PubMed 18206309Bishop A, Foster NE, Thomas E, Hay EM. How does the self-reported clinical management of patients with low back pain relate to the attitudes and beliefs of health care practitioners? A survey of UK general practitioners and physiotherapists. Pain. 2008 Mar;135(1-2):187-95. doi: 10.1016/j.pain.2007.11.010.
- Results publication: PubMed 28187918Friedman BW, Irizarry E, Solorzano C, Khankel N, Zapata J, Zias E, Gallagher EJ. Diazepam Is No Better Than Placebo When Added to Naproxen for Acute Low Back Pain. Ann Emerg Med. 2017 Aug;70(2):169-176.e1. doi: 10.1016/j.annemergmed.2016.10.002. Epub 2017 Feb 7.
- Results publication: PubMed 26501533Friedman BW, Dym AA, Davitt M, Holden L, Solorzano C, Esses D, Bijur PE, Gallagher EJ. Naproxen With Cyclobenzaprine, Oxycodone/Acetaminophen, or Placebo for Treating Acute Low Back Pain: A Randomized Clinical Trial. JAMA. 2015 Oct 20;314(15):1572-80. doi: 10.1001/jama.2015.13043.
- Results publication: PubMed 8167640Coste J, Le Parc JM, Berge E, Delecoeuillerie G, Paolaggi JB. [French validation of a disability rating scale for the evaluation of low back pain (EIFEL questionnaire)]. Rev Rhum Ed Fr. 1993 May;60(5):335-41. French.
- Results publication: PubMed 6222486Roland M, Morris R. A study of the natural history of back pain. Part I: development of a reliable and sensitive measure of disability in low-back pain. Spine (Phila Pa 1976). 1983 Mar;8(2):141-4. doi: 10.1097/00007632-198303000-00004. No abstract available.
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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.
D'USSEL Marguerite, MD principal investigator
Fondation Hôpital Saint-Joseph
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing delivery of the low back pain booklet in people with Low Back Pain, run by Fondation Hôpital Saint-Joseph 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 3 inclusion and 7 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 31 Mar 2022. 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?
Difference in the evolution of the EIFEL score at 3 months after inclusion between the 2 patient groups (time frame: 3 months after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03953625, which also lists 7 linked publications.
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 31 Mar 2022.