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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 oppdatert 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Antatt)

600

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Adult patients admitted for orthopedic trauma surgery following traumatic fracture

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / 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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Chronic Post-traumatic Pain
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Visuell analog skala (VAS) smerteskår
Tidsramme: Fra sykehusinnleggelse til 6 måneder etter traume
Smerteintensitet vurdert ved hjelp av en visuell analog skala (VAS). Poengsummer varierer fra 0 (ingen smerte) til 10 (verste tenkelige smerte).
Fra sykehusinnleggelse til 6 måneder etter traume
Injury Severity Score (ISS)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University Hospital, Montpellier

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. juli 2026

Primær fullføring (Antatt)

1. september 2028

Studiet fullført (Antatt)

1. desember 2028

Datoer for studieregistrering

Først innsendt

21. juni 2026

Først innsendt som oppfylte QC-kriteriene

1. juli 2026

Først lagt ut (Faktiske)

6. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

6. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

1. juli 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • TRAUMA PAIN Surgery

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Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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