The Biopsychosocial Model to Identify Risk Factors for Chronic Postoperative Pain in Orthopedic Trauma Surgery Patients (TRAUMA PAIN)
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienkontakt
- Name: Sophie Bringuier, PhD
- Telefonnummer: +33467338661
- E-Mail: s-bringuierbranchereau@chu-montpellier.fr
Studieren Sie die Kontaktsicherung
- Name: Lucas Deffontis, MD, MSc
- Telefonnummer: +33467338256
- E-Mail: l-deffontis@chu-montpellier.fr
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Probenahmeverfahren
Studienpopulation
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
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TRAUMA-PAIN SURGERY Cohort
This cohort includes adult patients undergoing orthopedic trauma surgery for traumatic fractures
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Chronic Post-traumatic Pain
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Visuelle Analogskala (VAS) Schmerzscore
Zeitfenster: Von der Krankenhausaufnahme bis 6 Monate nach dem Trauma
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Schmerzintensität bewertet mittels einer visuellen Analogskala (VAS).
Die Werte reichen von 0 (kein Schmerz) bis 10 (vorstellbar stärkster Schmerz).
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Von der Krankenhausaufnahme bis 6 Monate nach dem Trauma
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Injury Severity Score (ISS)
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- TRAUMA PAIN Surgery
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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