Biopsychosocial approach for acute low back pain in the emergency department

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, stepped-wedge cluster-randomized trial evaluates a biopsychosocial intervention that combines pain medication, physical therapy, psychological support, and social care for adults with acute non-traumatic low back pain presenting to emergency departments in Paris. Participants must be 18–55 years old, have moderate to severe pain, and be able to attend follow-up at 3 months. The study aims to determine whether this integrated approach improves pain and function compared with standard care, within an emergency department setting. Red flags, language requirements, and follow-up feasibility are used to define eligibility and safety. The trial builds on evidence suggesting benefits of biopsychosocial strategies for chronic low back pain and adapts them to the acute setting.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients aged 18 to 55 presenting to a participating emergency department, and
* Presenting with acute non-traumatic low back pain, newly developed or worsened within the past 7 days.
* Moderate to severe pain, defined as a score of ≥4 on a 0-10 numerical rating scale.
* Provision of informed consent after being given the information sheet.
* Patients covered by social security (excluding AME).

Exclusion Criteria:

* Presence of a 'red flag' according to HAS guidelines, including: motor neurological deficit or cauda equina syndrome, non-mechanical pain, trauma, active neoplastic disease or history of inflammatory rheumatism, suspected osteoarticular infection, recent spinal surgery with worsening symptoms, suspected acute vascular pathology, prolonged use of medications or corticosteroids, significant structural spinal deformity, or deterioration of general health.
* Inability to attend the 3-month follow-up.
* Poor command of French.
* Patient under guardianship/curatorship or deprived of liberty.
* Pregnant or breastfeeding women

Where it's running

• Emergency department, Hôpital Pitié Salpêtrière
  Paris, France Recruiting

Study contacts

• Principal investigator: Héloïse BANNELIER, Doctor — Assistance Publique - Hôpitaux de Paris
• Study coordinator: Héloïse BANNELIER, Doctor
• Email: heloise.bannelier@aphp.fr
• Phone: + 33 6 48 07 86 23

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.