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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

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
delivery of the low back pain booklet
Sponsored by
Fondation Hôpital Saint-Joseph
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Common Acute Low Back Pain, Low Back Pain Booklet, Health Insurance

Eligibility Criteria

20 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Groupe Hospitalier Paris Saint Joseph

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

no delivery of the low back pain booklet

delivery of the low back pain booklet

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Percentage of patients who have read the booklet
Differences between the 2 groups at 3 months
Percentage of patients who consulted the booklet on the ameli.fr website
Differences between the 2 groups at 3 months
Percentage of patients who have resumed or started physical activity as recommended in the booklet
Differences between the 2 groups at 3 months
Percentage of patients performing the recommended exercises
Differences between the 2 groups at 3 months
Percentage of patients still suffering from low back pain (defined by the persistence of back pain)
Differences between the 2 groups at 3 months
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
Duration of evolution of the initial low back pain episode if resolving
Differences between the 2 groups at 3 months
Duration of any work stoppage related to low back pain
Differences between the 2 groups at 3 months
Number of medical consultations
Differences between the 2 groups at 3 months
Number of physiotherapy or osteopathy sessions
Differences between the 2 groups at 3 months
Number of additional examinations
Differences between the 2 groups at 3 months
Number of analgesics taken per day during the last 72 hours (classified by WHO levels)
Differences between the 2 groups at 3 months
Satisfaction with the information given about the booklet
Numerical scale (from 0 to 10) Differences between the 2 groups at 3 months

Full Information

First Posted
May 15, 2019
Last Updated
March 30, 2022
Sponsor
Fondation Hôpital Saint-Joseph
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1. Study Identification

Unique Protocol Identification Number
NCT03953625
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
November 29, 2018 (Actual)
Primary Completion Date
May 13, 2020 (Actual)
Study Completion Date
October 26, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Hôpital Saint-Joseph

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Common Acute Low Back Pain, Low Back Pain Booklet, Health Insurance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
no delivery of the low back pain booklet
Arm Type
No Intervention
Arm Description
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.
Arm Title
delivery of the low back pain booklet
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
delivery of the low back pain booklet
Intervention Description
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.
Primary Outcome Measure Information:
Title
Difference in the evolution of the EIFEL score at 3 months after inclusion between the 2 patient groups
Description
A difference of 5 points in the EIFEL score between the two groups, already validated in previous studies, will be considered clinically significant.
Time Frame
3 months after inclusion
Secondary Outcome Measure Information:
Title
Percentage of patients who have read the booklet
Description
Differences between the 2 groups at 3 months
Time Frame
3 months after inclusion
Title
Percentage of patients who consulted the booklet on the ameli.fr website
Description
Differences between the 2 groups at 3 months
Time Frame
3 months after inclusion
Title
Percentage of patients who have resumed or started physical activity as recommended in the booklet
Description
Differences between the 2 groups at 3 months
Time Frame
3 months after inclusion
Title
Percentage of patients performing the recommended exercises
Description
Differences between the 2 groups at 3 months
Time Frame
3 months after inclusion
Title
Percentage of patients still suffering from low back pain (defined by the persistence of back pain)
Description
Differences between the 2 groups at 3 months
Time Frame
3 months after inclusion
Title
Numerical scale evaluating the pain
Description
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
Time Frame
3 months after inclusion
Title
Duration of evolution of the initial low back pain episode if resolving
Description
Differences between the 2 groups at 3 months
Time Frame
3 months after inclusion
Title
Duration of any work stoppage related to low back pain
Description
Differences between the 2 groups at 3 months
Time Frame
3 months after inclusion
Title
Number of medical consultations
Description
Differences between the 2 groups at 3 months
Time Frame
3 months after inclusion
Title
Number of physiotherapy or osteopathy sessions
Description
Differences between the 2 groups at 3 months
Time Frame
3 months after inclusion
Title
Number of additional examinations
Description
Differences between the 2 groups at 3 months
Time Frame
3 months after inclusion
Title
Number of analgesics taken per day during the last 72 hours (classified by WHO levels)
Description
Differences between the 2 groups at 3 months
Time Frame
3 months after inclusion
Title
Satisfaction with the information given about the booklet
Description
Numerical scale (from 0 to 10) Differences between the 2 groups at 3 months
Time Frame
3 months after inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
D'USSEL Marguerite, MD
Organizational Affiliation
Fondation Hôpital Saint-Joseph
Official's Role
Principal Investigator
Facility Information:
Facility Name
Groupe Hospitalier Paris Saint Joseph
City
Paris
State/Province
Ile-de-France
ZIP/Postal Code
75014
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
19635343
Citation
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.
Results Reference
result
PubMed Identifier
21451099
Citation
Nicholas 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 Reference
result
PubMed Identifier
18206309
Citation
Bishop 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 Reference
result
PubMed Identifier
28187918
Citation
Friedman 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 Reference
result
PubMed Identifier
26501533
Citation
Friedman 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 Reference
result
PubMed Identifier
8167640
Citation
Coste 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 Reference
result
PubMed Identifier
6222486
Citation
Roland 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.
Results Reference
result

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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

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