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Comprehensive Biopsychosocial Approach for Acute Low Back Pain Management in the Emergency Department: a Stepped-wedge Cluster-randomized Clinical Trial

RecruitingNAAges 18 Years - 55 YearsAllAssistance Publique - Hôpitaux de Paris
NCT07375914 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Acute low back pain, the second leading cause of medical consultations in France, poses a major public health challenge, particularly because of its high risk of progressing to chronic low back pain-the leading cause worldwide of years lived with disability. Pharmacological treatments such as paracetamol, opioids, non-steroidal anti-inflammatory drugs (NSAIDs) and muscle relaxants show limited benefit in terms of pain intensity or functional disability. Non-pharmacological treatments, including exercise therapy and psychological support, show promising results but remain hampered by methodological biases and small sample sizes. A biopsychosocial approach that combines pharmacological treatments, physical therapy, psychological support and social interventions has demonstrated moderate improvements in pain and function for chronic low back pain but remains insufficiently studied for acut

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📋 Eligibility rules (as published)
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
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What it tests

  • Biopsychosocial intervention
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Where

1 site
Emergency department, Hôpital Pitié Salpêtrière
Paris, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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