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This study aims to assess multidimensional risk factors for chronic post-traumatic pain in polytrauma patients. The purpose is to better understand pain chronification mechanisms by quantifying the interaction between clinical, biological, therapeutic, and psychosocial factors during hospitalization, with the ultimate goal of developing a convergent model to predict patients at risk before hospital discharge.
According to the International Classification of Diseases 11th (ICD-11) classification, chronic post-traumatic pain is defined as pain persisting for more than 3 months following tissue injury. Given its physical, psychological, and social consequences, chronic pain represents a major source of disability, functional limitation, and impaired quality of life. Chronic pain frequently develops after accidental trauma, particularly in patients sustaining musculoskeletal injuries such as fractures.
The primary objective of this study is to identify early risk factors associated with chronic post-traumatic pain. In this study, patients undergo a comprehensive multidimensional evaluation throughout hospitalization. Trauma-related characteristics, including injury mechanism, severity, and lesion location, as well as therapeutic management, are systematically documented. Psychosocial factors and post-traumatic symptoms are assessed during hospitalization and at 3- and 6-month follow-up visits.
In addition to clinical and psychosocial assessments, biological samples are collected from hospital admission until discharge. This biological component focuses on brain-derived neurotrophic factor (BDNF). BDNF, initially described for its role in synaptic plasticity, has been increasingly implicated in central sensitization processes involved in pain chronification. By integrating clinical, biological, therapeutic, and psychosocial data, this study aims to characterize mechanisms associated with chronic post-traumatic pain and to develop a convergent predictive model to identify patients at high risk prior to hospital discharge.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TRAUMApain ICU Cohort | This cohort includes adult patients admitted to the intensive care unit (ICU) for traumatic injuries. Eligible patients are aged 18 years or older, with an Abbreviated Injury Scale (AIS) score greater than 1, and have at least one documented fracture. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| biological collection of residual peripheral venous blood samples | Other | use of samples from this collection for BDNF (Brain-Derived Neurotrophic Factor) analysis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Chronic post-traumatic pain | Presence of chronic post-traumatic pain, defined as a visual analog scale (VAS) score greater than 3 persisting more than 3 months post-trauma. The Visual Analog Scale (VAS) Scores range from 0 (no pain) to 10 (worst imaginable pain). | more than 3 months post-trauma |
| Measure | Description | Time Frame |
|---|---|---|
| Behavioral Pain Scale (BPS) Score | Pain assessed using the Behavioral Pain Scale (BPS) in mechanically ventilated and intubated patients. Scores range from 3 (no pain) to 12 (maximum pain). | From ICU admission until extubation |
| Visual Analog Scale (VAS) Pain Score |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients admitted to the intensive care unit following traumatic injury, with an AIS score greater than 1 and at least one fracture, are included in this study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sophie Bringuier, PhD | Contact | +33467338661 | s-bringuierbranchereau@chu-montpellier.fr |
| Name | Affiliation | Role |
|---|---|---|
| CAPDEVILA Xavier, MD PhD | x-capdevila@chu-montpellier.fr | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesiology and critical care, Lapeyronie University Hospital | Recruiting | Montpellier | 34295 | France |
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Peripheral venous blood samples are collected and serum is isolated and stored for biomarker analyses.
| collection of data from medical records | Other | collection of data from medical records |
|
Pain intensity assessed using a visual analog scale (VAS). Scores range from 0 (no pain) to 10 (worst imaginable pain). |
| From hospital admission until 6 months post-trauma |
| Injury Severity Score (ISS) | Severity of traumatic injuries assessed using the Injury Severity Score. Scores range from 1 (minor injury) to 75 (most severe injury). | At ICU admission |
| Pain Catastrophizing Profile | Pain catastrophizing assessed using the Pain Catastrophizing Scale (PCS) as soon as the patient is able to self-report during the ICU stay. Scores range from 0 (no catastrophizing) to 52 (maximum catastrophizing). | During ICU stay up to 28 days |
| Trait Anxiety (STAI-Trait) | Trait anxiety assessed using the State-Trait Anxiety Inventory - Trait subscale (STAI-Trait) as soon as the patient is conscious and able to self-report during the ICU stay. Scores range from 20 (low trait anxiety) to 80 (high trait anxiety). | Once during ICU stay (up to 28 days) when the patient is conscious and able to self-report |
| Anxiety Intensity (Visual Analog Scale) | State anxiety intensity assessed using a Visual Analog Scale (VAS) in non-intubated patients able to self-report during the ICU stay, and during follow-up up to 6 months post-trauma.Scores range from 0 (no anxiety) to 10 (worst imaginable anxiety). | From hospital admission through 6 months post-trauma |
| Neuropathic Pain Characteristics (DN4 Questionnaire) | Neuropathic pain characteristics assessed using the DN4 questionnaire as soon as the patient is able to self-report during hospitalization if pre-existing chronic pain is present, and reassessed at 3 and 6 months post-trauma in patients reporting pain.Scores range from 0 (no neuropathic pain) to 10 (definite neuropathic pain). | During ICU stay and at 3 and 6 months post-trauma |
| Brief Pain Inventory (BPI) | Pain assessed with the Brief Pain Inventory (BPI), including two subscales: pain severity and pain interference. Both subscale scores range from 0 (no pain / no interference) to 10 (worst pain / maximum interference). | At 3 and 6 months post-trauma after hospital discharge |
| Post-Traumatic Stress Symptoms (PCL-5) | Post-traumatic stress symptoms assessed with the PCL-5 questionnaire. Scores range from 0 (no symptoms) to 80 (severe symptoms). | 3 and 6 months post-trauma |
| Opioid Misuse (POMI) | Opioid misuse assessed with the POMI questionnaire. Scores range from 0 (no misuse) to 6 (high risk of misuse). | 3 and 6 months post-trauma |
| Quality of Life (SF-12) | Quality of life assessed with the SF-12 questionnaire, including two component scores: Physical Component Summary (PCS) and Mental Component Summary (MCS). Scores are standardized on a 0 to 100 scale, with higher scores indicating better quality of life. | 3 and 6 months post-trauma |
| Anxiety and Depression (HADS) | Anxiety and depression assessed with the Hospital Anxiety and Depression Scale (HADS), including two subscales: anxiety and depression. A total score is also calculated by summing both subscales. Each subscale score ranges from 0 to 21, and the total score ranges from 0 (no symptoms) to 42 (severe anxiety and depression). | 3 and 6 months post-trauma |