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NCT Number: NCT07491354

The Biopsychosocial Model to Identify Risk Factors for Chronic Post-traumatic Pain in ICU Patients

This study aims to assess multidimensional risk factors for chronic post-traumatic pain in polytrauma 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.

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Key information

Conditions

Post Traumatic Chronic Pain

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Anesthesiology and critical care, Lapeyronie University Hospital

Montpellier, 34295, France

Location status: Recruiting

Location contact

Xavier XC CAPDEVILA, MD, PhD

CONTACT

[email protected]

Xavier XC CAPDEVILA, MD, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

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. Trauma-related characteristics, including injury mechanism, severity, and lesion location, 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients aged 18 years or older
  • Patients with an Abbreviated Injury Scale (AIS) score greater than 1
  • Patients presenting with at least one documented fracture

Exclusion criteria

  • Patients with an isolated fracture of the carpal bones
  • Patients with isolated traumatic brain injury
  • Patients with isolated minor facial trauma
  • Patients with isolated digestive trauma

Treatment and study plan

biological collection of residual peripheral venous blood samples

Other

use of samples from this collection for BDNF (Brain-Derived Neurotrophic Factor) analysis

collection of data from medical records

Other

collection of data from medical records

Primary outcomes

  1. Chronic post-traumatic pain

    Time frame: 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).

Secondary outcomes

  1. Behavioral Pain Scale (BPS) Score

    Time frame: From ICU admission until extubation

    Pain assessed using the Behavioral Pain Scale (BPS) in mechanically ventilated and intubated patients. Scores range from 3 (no pain) to 12 (maximum pain).

  2. Visual Analog Scale (VAS) Pain Score

    Time frame: From hospital admission until 6 months post-trauma

    Pain intensity assessed using a visual analog scale (VAS). Scores range from 0 (no pain) to 10 (worst imaginable pain).

  3. Injury Severity Score (ISS)

    Time frame: At ICU admission

    Severity of traumatic injuries assessed using the Injury Severity Score. Scores range from 1 (minor injury) to 75 (most severe injury).

  4. Pain Catastrophizing Profile

    Time frame: During ICU stay up to 28 days

    Pain catastrophizing assessed using the Pain Catastrophizing Scale (PCS) as soon as the patient is able to self-report during the ICU stay. Scores range from 0 (no catastrophizing) to 52 (maximum catastrophizing).

  5. Trait Anxiety (STAI-Trait)

    Time frame: Once during ICU stay (up to 28 days) when the patient is conscious and able to self-report

    Trait anxiety assessed using the State-Trait Anxiety Inventory - Trait subscale (STAI-Trait) as soon as the patient is conscious and able to self-report during the ICU stay. Scores range from 20 (low trait anxiety) to 80 (high trait anxiety).

  6. Anxiety Intensity (Visual Analog Scale)

    Time frame: From hospital admission through 6 months post-trauma

    State anxiety intensity assessed using a Visual Analog Scale (VAS) in non-intubated patients able to self-report during the ICU stay, and during follow-up up to 6 months post-trauma.Scores range from 0 (no anxiety) to 10 (worst imaginable anxiety).

  7. Neuropathic Pain Characteristics (DN4 Questionnaire)

    Time frame: During ICU stay and at 3 and 6 months post-trauma

    Neuropathic pain characteristics assessed using the DN4 questionnaire as soon as the patient is able to self-report during hospitalization if pre-existing chronic pain is present, and reassessed at 3 and 6 months post-trauma in patients reporting pain.Scores range from 0 (no neuropathic pain) to 10 (definite neuropathic pain).

  8. Brief Pain Inventory (BPI)

    Time frame: At 3 and 6 months post-trauma after hospital discharge

    Pain assessed with the Brief Pain Inventory (BPI), including two subscales: pain severity and pain interference.

    Both subscale scores range from 0 (no pain / no interference) to 10 (worst pain / maximum interference).

  9. Post-Traumatic Stress Symptoms (PCL-5)

    Time frame: 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).

  10. Opioid Misuse (POMI)

    Time frame: 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).

  11. Quality of Life (SF-12)

    Time frame: 3 and 6 months post-trauma

    Quality of life assessed with the SF-12 questionnaire, including two component scores: Physical Component Summary (PCS) and Mental Component Summary (MCS). Scores are standardized on a 0 to 100 scale, with higher scores indicating better quality of life.

  12. Anxiety and Depression (HADS)

    Time frame: 3 and 6 months post-trauma

    Anxiety and depression assessed with the Hospital Anxiety and Depression Scale (HADS), including two subscales: anxiety and depression. A total score is also calculated by summing both subscales.

    Each subscale score ranges from 0 to 21, and the total score ranges from 0 (no symptoms) to 42 (severe anxiety and depression).

Study contacts

Contact information is provided by the study sponsor or research team.

Sophie Bringuier, PhD

CONTACT

[email protected]

+33467338661

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Acronym: TRAUMA-PAIN

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Mar 24, 2026
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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