[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100621845":3},{"organization":4,"outcomesModule":7,"designInfo":39,"detailedDescription":16,"studyPopulation":16,"armGroups":45,"interventions":56,"overallOfficials":61,"centralContacts":65,"locations":74,"responsibleParty":92,"collaborators":16,"id":94,"slug":95,"hasResults":96,"nctId":97,"briefTitle":98,"officialTitle":98,"acronym":99,"eligibilityCriteria":100,"healthyVolunteers":96,"sex":101,"minAge":102,"maxAge":103,"enrollmentInfo":104,"targetDuration":16,"studyType":107,"phases":108,"briefSummary":110,"conditions":111,"keywords":113,"overallStatus":77,"whyStopped":16,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":125},{"fullName":5,"class":6},"Assistance Publique - Hôpitaux de Paris","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":16},[9],{"measure":10,"description":11,"timeFrame":12},"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",[14,17,20,22,26,30,33,35],{"measure":15,"description":16,"timeFrame":12},"Pain intensity at 7 days, measured by the BPI SF intensity score.",null,{"measure":18,"description":19,"timeFrame":12},"Number of pain-free days after the emergency department visit","Number of days with BPI intensity at 0",{"measure":21,"description":16,"timeFrame":12},"Proportion of patients pain free at 7 days",{"measure":23,"description":24,"timeFrame":25},"Number of days off work","Number of days off work at 7 days and at 3 months.","7 days and 3 months.",{"measure":27,"description":28,"timeFrame":29},"Functional disability","Functional disability at 3 months, measured using the Roland-Morris Disability Questionnaire.","3 months",{"measure":31,"description":32,"timeFrame":29},"Patient satisfaction and quality of life","Patient satisfaction and quality of life at 3 months, assessed using the EQ-5D-5L",{"measure":34,"description":16,"timeFrame":29},"Number of X-rays, CT scans, and MRI scans of the spine performed",{"measure":36,"description":37,"timeFrame":38},"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",{"allocation":40,"interventionModel":41,"interventionModelDescription":16,"primaryPurpose":42,"observationalModel":16,"timePerspective":16,"maskingInfo":43},"RANDOMIZED","CROSSOVER","HEALTH_SERVICES_RESEARCH",{"masking":44,"maskingDescription":16,"whoMasked":16},"NONE",[46,50],{"label":47,"type":48,"description":49,"interventionNames":16},"Control group","NO_INTERVENTION","Usual care - Standard care for acute non-specific low back pain at clinician's discretion",{"label":51,"type":52,"description":53,"interventionNames":54},"Intervention group","EXPERIMENTAL","Biopsychosocial approach",[55],"Other: Biopsychosocial intervention",[57],{"type":6,"name":58,"description":59,"armGroupLabels":60,"otherNames":16},"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.",[51],[62],{"name":63,"affiliation":5,"role":64},"Héloïse BANNELIER, Doctor","PRINCIPAL_INVESTIGATOR",[66,70],{"name":63,"role":67,"phone":68,"phoneExt":16,"email":69},"CONTACT","+ 33 6 48 07 86 23","heloise.bannelier@aphp.fr",{"name":71,"role":67,"phone":72,"phoneExt":16,"email":73},"Yonathan FREUND, Professor","+33 1 42 17 72 82","yonathan.freund@aphp.fr",[75],{"facility":76,"status":77,"city":78,"state":16,"zip":16,"country":79,"countryCode":80,"cosmosGeoPoint":81,"geoPoint":86,"contacts":87},"Emergency department, Hôpital Pitié Salpêtrière","RECRUITING","Paris","France","FR",{"type":82,"coordinates":83},"Point",[84,85],2.3488,48.85341,{"lat":85,"lon":84},[88,90],{"name":89,"role":67,"phone":68,"phoneExt":16,"email":69},"Héloise BANNELIER, Doctor",{"name":91,"role":67,"phone":72,"phoneExt":16,"email":73},"Yonathan FREUND, PU-PH",{"type":93,"investigatorFullName":16,"investigatorTitle":16,"investigatorAffiliation":16,"oldNameTitle":16,"oldOrganization":16},"SPONSOR","100621845","comprehensive-biopsychosocial-approach-for-acute-low-back-pain-management-in-the-emergency-department-a-stepped-wedge-cluster-randomized-clinical-trial-100621845",false,"NCT07375914","Comprehensive Biopsychosocial Approach for Acute Low Back Pain Management in the Emergency Department: a Stepped-wedge Cluster-randomized Clinical Trial","CALM-ED","Inclusion Criteria:\n\n* Patients aged 18 to 55 presenting to a participating emergency department, and\n* Presenting with acute non-traumatic low back pain, newly developed or worsened within the past 7 days.\n* Moderate to severe pain, defined as a score of ≥4 on a 0-10 numerical rating scale.\n* Provision of informed consent after being given the information sheet.\n* Patients covered by social security (excluding AME).\n\nExclusion Criteria:\n\n* 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.\n* Inability to attend the 3-month follow-up.\n* Poor command of French.\n* Patient under guardianship\u002Fcuratorship or deprived of liberty.\n* Pregnant or breastfeeding women","ALL","18 Years","55 Years",{"count":105,"type":106},782,"ESTIMATED","INTERVENTIONAL",[109],"NA","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.\n\nA 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 (\\\u003C10 %) 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.",[112],"Non-traumatic Low Back Pain",[114,115],"Emergency medicine","Acute Low back pain","2026-10-07",{"date":118,"type":119},"2026-10-08","ACTUAL",{"date":121,"type":119},"2026-04-14",{"date":123,"type":106},"2027-06-14",{"name":5,"class":6},1]