The Biopsychosocial Model to Identify Risk Factors for Chronic Postoperative Pain in Orthopedic Trauma Surgery Patients (TRAUMA PAIN)
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Sophie Bringuier, PhD
- Numéro de téléphone: +33467338661
- E-mail: s-bringuierbranchereau@chu-montpellier.fr
Sauvegarde des contacts de l'étude
- Nom: Lucas Deffontis, MD, MSc
- Numéro de téléphone: +33467338256
- E-mail: l-deffontis@chu-montpellier.fr
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
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TRAUMA-PAIN SURGERY Cohort
This cohort includes adult patients undergoing orthopedic trauma surgery for traumatic fractures
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|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Chronic Post-traumatic Pain
Délai: 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). |
More than 3 months post-trauma
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Échelle Visuelle Analogique (EVA) Score de Douleur
Délai: De l'admission à l'hôpital jusqu'à 6 mois après le traumatisme
|
Intensité de la douleur évaluée à l'aide d'une échelle visuelle analogique (EVA).
Les scores vont de 0 (aucune douleur) à 10 (douleur la plus intense imaginable).
|
De l'admission à l'hôpital jusqu'à 6 mois après le traumatisme
|
|
Injury Severity Score (ISS)
Délai: Baseline (At hospital admission, day 0)
|
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
Délai: Baseline (At hospital admission, day 0)
|
Pain catastrophizing assessed using the Pain Catastrophizing Scale (PCS).
Scores range from 0 (no catastrophizing) to 52 (maximum catastrophizing).
|
Baseline (At hospital admission, day 0)
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|
Trait Anxiety (STAI-Trait)
Délai: Baseline (At hospital admission, day 0)
|
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)
|
|
Anxiety Intensity (Visual Analog Scale)
Délai: From hospital admission through 6 months post-trauma
|
State anxiety intensity assessed using a Visual Analog Scale (VAS).
Scores range from 0 (no anxiety) to 10 (worst imaginable anxiety).
|
From hospital admission through 6 months post-trauma
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Neuropathic Pain Characteristics (DN4 Questionnaire)
Délai: During hospitalization and at 3 and 6 months post-trauma
|
Neuropathic pain characteristics assessed using the DN4 questionnaire.
Scores range from 0 (no neuropathic pain) to 10 (definite neuropathic pain).
|
During hospitalization and at 3 and 6 months post-trauma
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Brief Pain Inventory (BPI)
Délai: 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
|
|
Post-Traumatic Stress Symptoms (PCL-5)
Délai: 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).
|
At 3 and 6 months post-trauma
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|
Opioid Misuse (POMI)
Délai: 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).
|
At 3 and 6 months post-trauma
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Quality of Life (SF-12)
Délai: At 3 and 6 months post-trauma
|
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)
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- TRAUMA PAIN Surgery
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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