The Biopsychosocial Model to Identify Risk Factors for Chronic Postoperative Pain in Orthopedic Trauma Surgery Patients (TRAUMA PAIN)
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Sophie Bringuier, PhD
- Numer telefonu: +33467338661
- E-mail: s-bringuierbranchereau@chu-montpellier.fr
Kopia zapasowa kontaktu do badania
- Nazwa: Lucas Deffontis, MD, MSc
- Numer telefonu: +33467338256
- E-mail: l-deffontis@chu-montpellier.fr
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Metoda próbkowania
Badana populacja
Opis
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 studiów
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
Interwencja / Leczenie |
|---|---|
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TRAUMA-PAIN SURGERY Cohort
This cohort includes adult patients undergoing orthopedic trauma surgery for traumatic fractures
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Chronic Post-traumatic Pain
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Skala Wizualno-Analogowa (VAS) Wynik Bólu
Ramy czasowe: Od przyjęcia do szpitala do 6 miesięcy po urazie
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Intensywność bólu oceniana za pomocą wizualnej skali analogowej (VAS).
Wyniki mieszczą się w zakresie od 0 (brak bólu) do 10 (najsilniejszy wyobrażalny ból).
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Od przyjęcia do szpitala do 6 miesięcy po urazie
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Injury Severity Score (ISS)
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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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Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Inne numery identyfikacyjne badania
- TRAUMA PAIN Surgery
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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