Comprehensive Biopsychosocial Approach for Acute Low Back Pain Management in the Emergency Department: a Stepped-wedge Cluster-randomized Clinical Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Biopsychosocial intervention.
- Who it may be relevant to
- Registry conditions: Non-traumatic Low Back Pain. Basic parameters: 18 years — 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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 typica
Primary outcome measures
- Pain Interference Score at 7 days [Time frame: 7 days]
Secondary outcome measures (8)
- Pain intensity at 7 days, measured by the BPI SF intensity score. [Time frame: 7 days]
- Number of pain-free days after the emergency department visit [Time frame: 7 days]
- Proportion of patients pain free at 7 days [Time frame: 7 days]
- Number of days off work [Time frame: 7 days and 3 months.]
- Functional disability [Time frame: 3 months]
- Patient satisfaction and quality of life [Time frame: 3 months]
- Number of X-rays, CT scans, and MRI scans of the spine performed [Time frame: 3 months]
- Total amount of opioids consumed [Time frame: 7 days and 3 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
France · 1 center
- Emergency department, Hôpital Pitié Salpêtrière — Paris
Identifiers
NCT: NCT07375914 · APHP251083 · IDRCB: 2025-A01588-41