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The Biopsychosocial Model to Identify Risk Factors for Chronic Postoperative Pain in Orthopedic Trauma Surgery Patients (TRAUMA PAIN)

1 juli 2026 uppdaterad av: University Hospital, Montpellier
This study aims to assess multidimensional risk factors for chronic post-traumatic pain in orthopedic trauma surgery patients. The purpose is to better understand pain chronification mechanisms by quantifying the interaction between clinical, biological, therapeutic, and psychosocial factors during hospitalization, with the ultimate goal of developing a convergent model to predict patients at risk before hospital discharge.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Beräknad)

600

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Testmetod

Icke-sannolikhetsprov

Studera befolkning

Adult patients admitted for orthopedic trauma surgery following traumatic fracture

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
TRAUMA-PAIN SURGERY Cohort
This cohort includes adult patients undergoing orthopedic trauma surgery for traumatic fractures
Biologisk: • biological collection
  • biological collection of residual peripheral venous blood samples
  • use of samples from this collection for BDNF (Brain-Derived Neurotrophic Factor) analysis
  • collection of data from medical records
  • collection of psychosocial and patient-reported outcome data

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Chronic Post-traumatic Pain
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Visual Analog Scale (VAS) Smärtskattning
Tidsram: Från sjukhusinläggning till 6 månader efter trauma
Smärtintensitet bedöms med en visuell analog skala (VAS). Poäng sträcker sig från 0 (ingen smärta) till 10 (värsta tänkbara smärta).
Från sjukhusinläggning till 6 månader efter trauma
Injury Severity Score (ISS)
Tidsram: 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).
Baseline (At hospital admission, day 0)
Pain Catastrophizing Profile
Tidsram: 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)
Trait Anxiety (STAI-Trait)
Tidsram: 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)
Tidsram: 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
Neuropathic Pain Characteristics (DN4 Questionnaire)
Tidsram: 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
Brief Pain Inventory (BPI)
Tidsram: At 3 and 6 months post-trauma

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)
Tidsram: At 3 and 6 months post-trauma
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
Opioid Misuse (POMI)
Tidsram: At 3 and 6 months post-trauma
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
Quality of Life (SF-12)
Tidsram: 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
Anxiety and Depression (HADS)
Tidsram: At 3 and 6 months post-trauma

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
Serum BDNF Concentration
Tidsram: From admission (before surgery ) until discharge (from day 1 to day 28)
Serum concentration of Brain-Derived Neurotrophic Factor measured during hospitalization.
From admission (before surgery ) until discharge (from day 1 to day 28)

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University Hospital, Montpellier

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 juli 2026

Primärt slutförande (Beräknad)

1 september 2028

Avslutad studie (Beräknad)

1 december 2028

Studieregistreringsdatum

Först inskickad

21 juni 2026

Först inskickad som uppfyllde QC-kriterierna

1 juli 2026

Första postat (Faktisk)

6 juli 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

6 juli 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

1 juli 2026

Senast verifierad

1 juni 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Andra studie-ID-nummer

  • TRAUMA PAIN Surgery

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