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

NCT07375914 | Not Yet Recruiting

• 2 other identifiers: APHP251083IDRCB: 2025-A01588-41
• Study Type: interventional
• Target: 782
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Non-traumatic Low Back Pain

Keywords

Emergency medicine; Acute Low back pain

Outcome Measures

Primary Outcomes (1)

• Pain Interference Score at 7 days

  Pain interference score at 7 days, assessed using the Pain Interference subscale of the Brief Pain Inventory - Short Form (BPI-SF). The score is calculated as the mean of 7 items (each rated 0-10) and reported on a 0-100 scale

  7 days

Secondary Outcomes (7)

• Pain intensity at 7 days, measured by the BPI SF intensity score.

  7 days

• Number of pain-free days after the emergency department visit

  7 days

• Total amount of opioids consumed

  7 days and 3 months

• Number of days off work

  7 days and 3 months.

• Functional disability

  3 months

Study Arms (2)

Control group

NO INTERVENTION

Usual care - Standard care for acute non-specific low back pain at clinician's discretion

Intervention group

EXPERIMENTAL

Biopsychosocial approach

Other: Biopsychosocial intervention

Interventions

Biopsychosocial intervention OTHER

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 typical recovery, self-management strategies, and appropriate follow-up. The intervention is introduced sequentially across 12 centers according to a stepped-wedge randomization schedule, with each site moving from control to intervention while maintaining standard emergency care.

Intervention group

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Officials

• Héloïse BANNELIER, Doctor

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Héloïse BANNELIER, Doctor

CONTACT

+ 33 6 48 07 86 23; heloise.bannelier@aphp.fr

Yonathan FREUND, Professor

CONTACT

+33 1 42 17 72 82; yonathan.freund@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2026
• First Posted: January 29, 2026
• Study Start: January 15, 2026
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): March 15, 2027
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share