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临床试验/NCT07685184
NCT07685184尚未招募不适用

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

University Hospital, Montpellier0 个研究点目标入组 600 人开始时间: 2026年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
600
主要终点
Chronic Post-traumatic Pain

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

Chronic Post-traumatic Pain

时间窗: More than 3 months post-trauma

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).

次要结局

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

研究者

申办方类型
Other
责任方
Sponsor

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