The Biopsychosocial Model to Identify Risk Factors for Chronic Postoperative Pain in Orthopedic Trauma Surgery Patients (TRAUMA PAIN)
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Sophie Bringuier, PhD
- Número de teléfono: +33467338661
- Correo electrónico: s-bringuierbranchereau@chu-montpellier.fr
Copia de seguridad de contactos de estudio
- Nombre: Lucas Deffontis, MD, MSc
- Número de teléfono: +33467338256
- Correo electrónico: l-deffontis@chu-montpellier.fr
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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TRAUMA-PAIN SURGERY Cohort
This cohort includes adult patients undergoing orthopedic trauma surgery for traumatic fractures
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Chronic Post-traumatic Pain
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Puntuación de dolor en la Escala Visual Analógica (EVA)
Periodo de tiempo: Desde el ingreso hospitalario hasta los 6 meses posteriores al trauma
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Intensidad del dolor evaluada mediante una escala analógica visual (EAV).
Las puntuaciones van de 0 (sin dolor) a 10 (el dolor más intenso imaginable).
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Desde el ingreso hospitalario hasta los 6 meses posteriores al trauma
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Injury Severity Score (ISS)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
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Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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Última actualización enviada que cumplió con los criterios de control de calidad
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Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- TRAUMA PAIN Surgery
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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