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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07491354
Acronym
TRAUMA-PAIN
Enrollment
400
Registered
2026-03-24
Start date
2024-07-29
Completion date
2027-07-29
Last updated
2026-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Traumatic Chronic Pain

Keywords

Post traumatic Chronic Pain, Intensive Care Units, Biopsychosocial model

Brief summary

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.

Detailed description

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.

Interventions

OTHERbiological 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

Sponsors

University Hospital, Montpellier
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Chronic post-traumatic painmore than 3 months post-traumaPresence 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

MeasureTime frameDescription
Behavioral Pain Scale (BPS) ScoreFrom ICU admission until extubationPain assessed using the Behavioral Pain Scale (BPS) in mechanically ventilated and intubated patients. Scores range from 3 (no pain) to 12 (maximum pain).
Visual Analog Scale (VAS) Pain ScoreFrom hospital admission until 6 months post-traumaPain intensity assessed using a visual analog scale (VAS). Scores range from 0 (no pain) to 10 (worst imaginable pain).
Injury Severity Score (ISS)At ICU admissionSeverity of traumatic injuries assessed using the Injury Severity Score. Scores range from 1 (minor injury) to 75 (most severe injury).
Pain Catastrophizing ProfileDuring ICU stay up to 28 daysPain 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).
Trait Anxiety (STAI-Trait)Once during ICU stay (up to 28 days) when the patient is conscious and able to self-reportTrait 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).
Anxiety Intensity (Visual Analog Scale)From hospital admission through 6 months post-traumaState 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).
Neuropathic Pain Characteristics (DN4 Questionnaire)During ICU stay and at 3 and 6 months post-traumaNeuropathic 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).
Brief Pain Inventory (BPI)At 3 and 6 months post-trauma after hospital dischargePain 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).
Post-Traumatic Stress Symptoms (PCL-5)3 and 6 months post-traumaPost-traumatic stress symptoms assessed with the PCL-5 questionnaire. Scores range from 0 (no symptoms) to 80 (severe symptoms).
Opioid Misuse (POMI)3 and 6 months post-traumaOpioid misuse assessed with the POMI questionnaire. Scores range from 0 (no misuse) to 6 (high risk of misuse).
Quality of Life (SF-12)3 and 6 months post-traumaQuality 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.
Anxiety and Depression (HADS)3 and 6 months post-traumaAnxiety 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).

Countries

France

Contacts

CONTACTSophie Bringuier, PhD
s-bringuierbranchereau@chu-montpellier.fr+33467338661
STUDY_DIRECTORCAPDEVILA Xavier, MD PhD

x-capdevila@chu-montpellier.fr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026