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

NCT03953625 | Completed

• 1 other identifier: Livret lombalgie
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Keywords

Common Acute Low Back Pain; Low Back Pain Booklet; Health Insurance

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months after inclusion

Secondary Outcomes (13)

• Percentage of patients who have read the booklet

  3 months after inclusion

• Percentage of patients who consulted the booklet on the ameli.fr website

  3 months after inclusion

• Percentage of patients who have resumed or started physical activity as recommended in the booklet

  3 months after inclusion

• Percentage of patients performing the recommended exercises

  3 months after inclusion

• Percentage of patients still suffering from low back pain (defined by the persistence of back pain)

  3 months after inclusion

Study Arms (2)

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.

Other: delivery of the low back pain booklet

Interventions

delivery of the low back pain booklet OTHER

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.

delivery of the low back pain booklet

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead

Study Sites (1)

Groupe Hospitalier Paris Saint Joseph

Paris, Île-de-France Region, 75014, France

Location

Related Publications (7)

• 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.

  PMID: 19635343 RESULT

• 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.

  PMID: 21451099 RESULT

• 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.

  PMID: 18206309 RESULT

• 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.

  PMID: 28187918 RESULT

• 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.

  PMID: 26501533 RESULT

• 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.

  PMID: 8167640 RESULT

• 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.

  PMID: 6222486 RESULT

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• D'USSEL Marguerite, MD

  Fondation Hôpital Saint-Joseph

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2019
• First Posted: May 16, 2019
• Study Start: November 29, 2018
• Primary Completion: May 13, 2020
• Study Completion: October 26, 2021
• Last Updated: March 31, 2022

Record last verified: 2022-03

Locations

FR (1)