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

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.

Study Overview

• Status: Recruiting
• Conditions: Post Traumatic Chronic Pain
• Intervention / Treatment: Other: collection of data from medical records; Other: biological collection of residual peripheral venous blood samples

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.

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

• Study Contact: Name: Sophie Bringuier, PhD; Phone Number: +33467338661; Email: s-bringuierbranchereau@chu-montpellier.fr

Study Locations

• France
  • Montpellier, France, 34295
    • Recruiting
    • Department of Anesthesiology and critical care, Lapeyronie University Hospital
    • Principal Investigator: Xavier XC CAPDEVILA, MD, PhD
    • Contact: Xavier XC CAPDEVILA, MD, PhD; Email: x-capdevila@chu-montpellier.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients admitted to the intensive care unit following traumatic injury, with an AIS score greater than 1 and at least one fracture, are included in this study.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
TRAUMApain ICU Cohort; This cohort includes adult patients admitted to the intensive care unit (ICU) for traumatic injuries. Eligible patients are aged 18 years or older, with an Abbreviated Injury Scale (AIS) score greater than 1, and have at least one documented fracture.	Other: collection of data from medical records; collection of data from medical records; Other: biological collection of residual peripheral venous blood samples; use of samples from this collection for BDNF (Brain-Derived Neurotrophic Factor) analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chronic post-traumatic pain	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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Study Director: CAPDEVILA Xavier, MD PhD, x-capdevila@chu-montpellier.fr

Study record dates

Study Major Dates

• Study Start (Actual): July 29, 2024
• Primary Completion (Estimated): July 29, 2027
• Study Completion (Estimated): July 29, 2027

Study Registration Dates

• First Submitted: February 17, 2026
• First Submitted That Met QC Criteria: March 18, 2026
• First Posted (Actual): March 24, 2026

Study Record Updates

• Last Update Posted (Actual): March 24, 2026
• Last Update Submitted That Met QC Criteria: March 18, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Biopsychosocial model; Intensive Care Units; Post traumatic Chronic Pain
• Other Study ID Numbers: 2025-07-324

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No