Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07375914

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Pain Interference Score at 7 days

    Time frame: 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

Secondary outcomes

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

    Time frame: 7 days

  2. Number of pain-free days after the emergency department visit

    Time frame: 7 days

    Number of days with BPI intensity at 0

  3. Proportion of patients pain free at 7 days

    Time frame: 7 days

  4. Number of days off work

    Time frame: 7 days and 3 months.

    Number of days off work at 7 days and at 3 months.

  5. Functional disability

    Time frame: 3 months

    Functional disability at 3 months, measured using the Roland-Morris Disability Questionnaire.

  6. Patient satisfaction and quality of life

    Time frame: 3 months

    Patient satisfaction and quality of life at 3 months, assessed using the EQ-5D-5L

  7. Number of X-rays, CT scans, and MRI scans of the spine performed

    Time frame: 3 months

  8. Total amount of opioids consumed

    Time frame: 7 days and 3 months

    Total amount of opioids consumed at 7 days and at 3 months (in morphine equivalent).

Study contacts

Contact information is provided by the study sponsor or research team.

Héloïse BANNELIER, Doctor

CONTACT

[email protected]

+ 33 6 48 07 86 23

Yonathan FREUND, Professor

CONTACT

[email protected]

+33 1 42 17 72 82

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: CALM-ED

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 29, 2026
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.