The Biopsychosocial Model to Identify Risk Factors for Chronic Post-traumatic Pain in ICU Patients
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: biological collection of residual peripheral venous blood samples, collection of data from medical records.
- Кому может быть актуально
- Состояния в реестре: Post Traumatic Chronic Pain. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Франция
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
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.
Подробное описание
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.
Вмешательства
- Другое biological collection of residual peripheral venous blood samples
use of samples from this collection for BDNF (Brain-Derived Neurotrophic Factor) analysis - Другое collection of data from medical records
collection of data from medical records
Первичные конечные точки
- Chronic post-traumatic pain [Срок оценки: more than 3 months post-trauma]
Вторичные конечные точки (12)
- Behavioral Pain Scale (BPS) Score [Срок оценки: From ICU admission until extubation]
- Visual Analog Scale (VAS) Pain Score [Срок оценки: From hospital admission until 6 months post-trauma]
- Injury Severity Score (ISS) [Срок оценки: At ICU admission]
- Pain Catastrophizing Profile [Срок оценки: During ICU stay up to 28 days]
- Trait Anxiety (STAI-Trait) [Срок оценки: Once during ICU stay (up to 28 days) when the patient is conscious and able to self-report]
- Anxiety Intensity (Visual Analog Scale) [Срок оценки: From hospital admission through 6 months post-trauma]
- Neuropathic Pain Characteristics (DN4 Questionnaire) [Срок оценки: During ICU stay and at 3 and 6 months post-trauma]
- Brief Pain Inventory (BPI) [Срок оценки: At 3 and 6 months post-trauma after hospital discharge]
- Post-Traumatic Stress Symptoms (PCL-5) [Срок оценки: 3 and 6 months post-trauma]
- Opioid Misuse (POMI) [Срок оценки: 3 and 6 months post-trauma]
- Quality of Life (SF-12) [Срок оценки: 3 and 6 months post-trauma]
- Anxiety and Depression (HADS) [Срок оценки: 3 and 6 months post-trauma]
Критерии участия
Критерии включения
- Adult patients aged 18 years or older
- Patients with an Abbreviated Injury Scale (AIS) score greater than 1
- Patients presenting with at least one documented fracture
Критерии исключения
- Patients with an isolated fracture of the carpal bones
- Patients with isolated traumatic brain injury
- Patients with isolated minor facial trauma
- Patients with isolated digestive trauma
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Франция · 1 центр
- Department of Anesthesiology and critical care, Lapeyronie University Hospital — Montpellier
Идентификаторы
NCT: NCT07491354 · 2025-07-324