Emergency department, Hôpital Pitié Salpêtrière
Paris, France
Location status: Recruiting
Location contact
Héloise BANNELIER, Doctor
CONTACT
Yonathan FREUND, PU-PH
CONTACT
NCT Number: NCT07375914
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.
Interested in participating?
Request Info18 year–55 year
All sexes
Interventional
Not applicable
Paris, France
Location status: Recruiting
Héloise BANNELIER, Doctor
CONTACT
Yonathan FREUND, PU-PH
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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
Time frame: 7 days
Time frame: 7 days
Number of days with BPI intensity at 0
Time frame: 7 days
Time frame: 7 days and 3 months.
Number of days off work at 7 days and at 3 months.
Time frame: 3 months
Functional disability at 3 months, measured using the Roland-Morris Disability Questionnaire.
Time frame: 3 months
Patient satisfaction and quality of life at 3 months, assessed using the EQ-5D-5L
Time frame: 3 months
Time frame: 7 days and 3 months
Total amount of opioids consumed at 7 days and at 3 months (in morphine equivalent).
Contact information is provided by the study sponsor or research team.
Héloïse BANNELIER, Doctor
CONTACT
Yonathan FREUND, Professor
CONTACT
Assistance Publique - Hôpitaux de Paris
Other
Acronym: CALM-ED
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.