The Biopsychosocial Model to Identify Risk Factors for Chronic Post-traumatic Pain in ICU Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 1
- 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 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.
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.
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.
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
- 否
入选标准
- •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
排除标准
- •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
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
- Behavioral Pain Scale (BPS) Score(From ICU admission until extubation)
- Visual Analog Scale (VAS) Pain Score(From hospital admission until 6 months post-trauma)
- Injury Severity Score (ISS)(At ICU admission)
- Pain Catastrophizing Profile(During ICU stay up to 28 days)
- Trait Anxiety (STAI-Trait)(Once during ICU stay (up to 28 days) when the patient is conscious and able to self-report)
- Anxiety Intensity (Visual Analog Scale)(From hospital admission through 6 months post-trauma)
- Neuropathic Pain Characteristics (DN4 Questionnaire)(During ICU stay and at 3 and 6 months post-trauma)
- Brief Pain Inventory (BPI)(At 3 and 6 months post-trauma after hospital discharge)
- Post-Traumatic Stress Symptoms (PCL-5)(3 and 6 months post-trauma)
- Opioid Misuse (POMI)(3 and 6 months post-trauma)
- Quality of Life (SF-12)(3 and 6 months post-trauma)
- Anxiety and Depression (HADS)(3 and 6 months post-trauma)