The Biopsychosocial Model to Identify Risk Factors for Chronic Postoperative Pain in Orthopedic Trauma Surgery Patients (TRAUMA PAIN)
研究概览
详细说明
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.
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名:Sophie Bringuier, PhD
- 电话号码:+33467338661
- 邮箱:s-bringuierbranchereau@chu-montpellier.fr
研究联系人备份
- 姓名:Lucas Deffontis, MD, MSc
- 电话号码:+33467338256
- 邮箱:l-deffontis@chu-montpellier.fr
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- Patient unable to exercise consent
- Patients unable to complete the self reported assessment questionnaires
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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TRAUMA-PAIN SURGERY Cohort
This cohort includes adult patients undergoing orthopedic trauma surgery for traumatic fractures
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Chronic Post-traumatic Pain
大体时间:More than 3 months post-trauma
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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
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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视觉模拟评分法(VAS)疼痛评分
大体时间:从入院到创伤后6个月
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使用视觉模拟评分法(VAS)评估疼痛强度。
评分范围从0(无痛)到10(可想象的最剧烈疼痛)。
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从入院到创伤后6个月
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Injury Severity Score (ISS)
大体时间:Baseline (At hospital admission, day 0)
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Severity of traumatic injuries assessed using the Injury Severity Score.
Scores range from 1 (minor injury) to 75 (most severe injury).
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Baseline (At hospital admission, day 0)
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Pain Catastrophizing Profile
大体时间:Baseline (At hospital admission, day 0)
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Pain catastrophizing assessed using the Pain Catastrophizing Scale (PCS).
Scores range from 0 (no catastrophizing) to 52 (maximum catastrophizing).
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Baseline (At hospital admission, day 0)
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Trait Anxiety (STAI-Trait)
大体时间:Baseline (At hospital admission, day 0)
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Trait anxiety assessed using the State-Trait Anxiety Inventory - Trait subscale (STAI-Trait). Scores range from 20 (low trait anxiety) to 80 (high trait anxiety). |
Baseline (At hospital admission, day 0)
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Anxiety Intensity (Visual Analog Scale)
大体时间:From hospital admission through 6 months post-trauma
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State anxiety intensity assessed using a Visual Analog Scale (VAS).
Scores range from 0 (no anxiety) to 10 (worst imaginable anxiety).
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From hospital admission through 6 months post-trauma
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Neuropathic Pain Characteristics (DN4 Questionnaire)
大体时间:During hospitalization and at 3 and 6 months post-trauma
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Neuropathic pain characteristics assessed using the DN4 questionnaire.
Scores range from 0 (no neuropathic pain) to 10 (definite neuropathic pain).
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During hospitalization and at 3 and 6 months post-trauma
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Brief Pain Inventory (BPI)
大体时间:At 3 and 6 months post-trauma
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Pain assessed with the Brief Pain Inventory (BPI), including pain severity and pain interference subscales. Both subscale scores range from 0 (no pain/no interference) to 10 (worst pain/maximum interference). |
At 3 and 6 months post-trauma
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Post-Traumatic Stress Symptoms (PCL-5)
大体时间:At 3 and 6 months post-trauma
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Post-traumatic stress symptoms assessed with the PCL-5 questionnaire.
Scores range from 0 (no symptoms) to 80 (severe symptoms).
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At 3 and 6 months post-trauma
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Opioid Misuse (POMI)
大体时间:At 3 and 6 months post-trauma
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Opioid misuse assessed with the POMI questionnaire.
Scores range from 0 (no misuse) to 6 (high risk of misuse).
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At 3 and 6 months post-trauma
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Quality of Life (SF-12)
大体时间:At 3 and 6 months post-trauma
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Quality of life assessed using the SF-12 questionnaire. Physical Component Summary (PCS) and Mental Component Summary (MCS) scores range from 0 to 100. Higher scores indicate better quality of life. |
At 3 and 6 months post-trauma
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Anxiety and Depression (HADS)
大体时间:At 3 and 6 months post-trauma
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Anxiety and depression assessed using the Hospital Anxiety and Depression Scale (HADS). Each subscale ranges from 0 to 21. Total score ranges from 0 to 42. |
At 3 and 6 months post-trauma
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Serum BDNF Concentration
大体时间:From admission (before surgery ) until discharge (from day 1 to day 28)
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Serum concentration of Brain-Derived Neurotrophic Factor measured during hospitalization.
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From admission (before surgery ) until discharge (from day 1 to day 28)
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- TRAUMA PAIN Surgery
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