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

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.

Study Overview

• Status: Recruiting
• Conditions: Non-traumatic Low Back Pain
• Intervention / Treatment: Other: Biopsychosocial intervention

• Study Type: Interventional
• Enrollment (Estimated): 782
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Héloise BANNELIER, Doctor; Phone Number: + 33 6 48 07 86 23; Email: heloise.bannelier@aphp.fr
• Study Contact Backup: Name: Yonathan FREUND, Professor; Phone Number: +33 1 42 17 72 82; Email: yonathan.freund@aphp.fr

Study Locations

• France
  • Paris, France
    • Recruiting
    • Emergency department, Hôpital Pitié Salpêtrière
    • Contact: Héloise BANNELIER, Doctor; Phone Number: + 33 6 48 07 86 23; Email: heloise.bannelier@aphp.fr
    • Contact: Yonathan FREUND, PU-PH; Phone Number: +33 1 42 17 72 82; Email: yonathan.freund@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; Usual care - Standard care for acute non-specific low back pain at clinician's discretion
Experimental: Intervention group; Biopsychosocial approach	Other: 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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity at 7 days, measured by the BPI SF intensity score.		7 days
Number of pain-free days after the emergency department visit	Number of days with BPI intensity at 0	7 days
Number of days off work	Number of days off work at 7 days and at 3 months.	7 days and 3 months.
Functional disability	Functional disability at 3 months, measured using the Roland-Morris Disability Questionnaire.	3 months
Patient satisfaction and quality of life	Patient satisfaction and quality of life at 3 months, assessed using the EQ-5D-5L	3 months
Number of X-rays, CT scans, and MRI scans of the spine performed		3 months
Proportion of patients pain free at 7 days		7 days
Total amount of opioids consumed	Total amount of opioids consumed at 7 days and at 3 months (in morphine equivalent).	7 days and 3 months

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Héloïse BANNELIER, Doctor, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2026
• Primary Completion (Estimated): April 14, 2027
• Study Completion (Estimated): June 14, 2027

Study Registration Dates

• First Submitted: January 21, 2026
• First Submitted That Met QC Criteria: January 21, 2026
• First Posted (Actual): January 29, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Emergency medicine; Acute Low back pain
• Other Study ID Numbers: APHP251083; IDRCB: 2025-A01588-41 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No