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

Assistance Publique - Hôpitaux de Paris

Status

Not yet enrolling

Conditions

Non-traumatic Low Back Pain

Treatments

Other: Biopsychosocial intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT07375914

IDRCB: 2025-A01588-41 (Other Identifier)

APHP251083

Details and patient eligibility

About

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.

Enrollment

782 estimated patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

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