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Набор скоро начнётся NCT07685184

The Biopsychosocial Model to Identify Risk Factors for Chronic Postoperative Pain in Orthopedic Trauma Surgery Patients

Наблюдательное Post Traumatic Chronic Pain

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.
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
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

This study aims to assess multidimensional risk factors for chronic post-traumatic pain in orthopedic trauma surgery 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.

Traumatic fractures requiring surgical treatment are among the most common causes of severe acute pain and may result in persistent pain despite fracture healing and satisfactory surgical outcomes. Chronic post-traumatic pain following orthopedic trauma surgery is associated with prolonged functional impairment, delayed return to work, psychological distress, and decreased quality of life.

Current evidence suggests that chronic post-traumatic pain results from a complex interaction between injury-related characteristics, biological vulnerability, therapeutic management, and psychosocial factors. However, these multidimensional determinants remain incompletely understood in orthopedic trauma populations.

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. Fracture-related characteristics, including fracture location, injury severity, surgical management, analgesic strategies, and rehabilitation pathways, 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

  • Биопрепарат • biological collection
    * biological collection of residual peripheral venous blood samples * use of samples from this collection for BDNF (Brain-Derived Neurotrophic Factor) analysis * collection of data from medical records * collection of psychosocial and patient-reported outcome data

Первичные конечные точки

  • Chronic Post-traumatic Pain [Срок оценки: More than 3 months post-trauma]
Вторичные конечные точки (12)
  • Visual Analog Scale (VAS) Pain Score [Срок оценки: From hospital admission until 6 months post-trauma]
  • Injury Severity Score (ISS) [Срок оценки: Baseline (At hospital admission, day 0)]
  • Pain Catastrophizing Profile [Срок оценки: Baseline (At hospital admission, day 0)]
  • Trait Anxiety (STAI-Trait) [Срок оценки: Baseline (At hospital admission, day 0)]
  • Anxiety Intensity (Visual Analog Scale) [Срок оценки: From hospital admission through 6 months post-trauma]
  • Neuropathic Pain Characteristics (DN4 Questionnaire) [Срок оценки: During hospitalization and at 3 and 6 months post-trauma]
  • Brief Pain Inventory (BPI) [Срок оценки: At 3 and 6 months post-trauma]
  • Post-Traumatic Stress Symptoms (PCL-5) [Срок оценки: At 3 and 6 months post-trauma]
  • Opioid Misuse (POMI) [Срок оценки: At 3 and 6 months post-trauma]
  • Quality of Life (SF-12) [Срок оценки: At 3 and 6 months post-trauma]
  • Anxiety and Depression (HADS) [Срок оценки: At 3 and 6 months post-trauma]
  • Serum BDNF Concentration [Срок оценки: From admission (before surgery ) until discharge (from day 1 to day 28)]

Критерии участия

Критерии включения

  • Adult patients aged 18 years or older
  • Surgical treatment for a traumatic fracture
  • Admission to an orthopedic trauma surgery department
  • Ability to participate in follow-up assessments
  • Informed consent

Критерии исключения

  • Patient unable to exercise consent
  • Patients unable to complete the self reported assessment questionnaires

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07685184 · TRAUMA PAIN Surgery

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗