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

Обзор

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 acute presentations. French guidelines advocate a combined strategy involving paracetamol, NSAIDs, physical activity and psychosocial risk assessment. However, a French multicentre retrospective study highlighted marked heterogeneity in clinical practice, along with a low adoption rate (\<10 %) of these recommendations in emergency departments, underscoring the need to strengthen adherence to evidence-based management strategies. We hypothesise that a multimodal intervention targeting physicians (guideline reminders) and patients (information on disease progression and multidisciplinary care plans), to enable the systematic implementation of all aspects of a biopsychosocial approach in emergency departments, could reduce short-term pain and disability in patients with acute low back pain.

Вмешательства

• Другое Biopsychosocial intervention
  The biopsychosocial intervention consists of a structured program implemented in participating emergency departments. It includes a standardized 3-hour online training session for physicians covering evidence-based management of acute low back pain, rational pharmacological use, promotion of physical activity, and consideration of psychosocial factors. A summary sheet will be given with key recommendations during the period. For patients, short educational materials provide information on typica

Первичные конечные точки

• Pain Interference Score at 7 days [Срок оценки: 7 days]

Вторичные конечные точки (8)

• Pain intensity at 7 days, measured by the BPI SF intensity score. [Срок оценки: 7 days]
• Number of pain-free days after the emergency department visit [Срок оценки: 7 days]
• Proportion of patients pain free at 7 days [Срок оценки: 7 days]
• Number of days off work [Срок оценки: 7 days and 3 months.]
• Functional disability [Срок оценки: 3 months]
• Patient satisfaction and quality of life [Срок оценки: 3 months]
• Number of X-rays, CT scans, and MRI scans of the spine performed [Срок оценки: 3 months]
• Total amount of opioids consumed [Срок оценки: 7 days and 3 months]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

Франция · 1 центр

• Emergency department, Hôpital Pitié Salpêtrière — Paris

Идентификаторы

NCT: NCT07375914 · APHP251083 · IDRCB: 2025-A01588-41

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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