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

NCT07491354 | Recruiting

• 1 other identifier: 2025-07-324
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Traumatic Chronic Pain

Keywords

Post traumatic Chronic Pain; Intensive Care Units; Biopsychosocial model

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Behavioral Pain Scale (BPS) Score

  From ICU admission until extubation

• Visual Analog Scale (VAS) Pain Score

  From hospital admission until 6 months post-trauma

• Injury Severity Score (ISS)

  At ICU admission

• Pain Catastrophizing Profile

  During ICU stay up to 28 days

• Trait Anxiety (STAI-Trait)

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

Study Arms (1)

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: biological collection of residual peripheral venous blood samples; Other: collection of data from medical records

Interventions

biological collection of residual peripheral venous blood samples OTHER

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

TRAUMApain ICU Cohort

collection of data from medical records OTHER

collection of data from medical records

TRAUMApain ICU Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Department of Anesthesiology and critical care, Lapeyronie University Hospital

Montpellier, 34295, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Peripheral venous blood samples are collected and serum is isolated and stored for biomarker analyses.

Study Officials

• CAPDEVILA Xavier, MD PhD

  x-capdevila@chu-montpellier.fr

  STUDY DIRECTOR

Central Study Contacts

Sophie Bringuier, PhD

CONTACT

+33467338661; s-bringuierbranchereau@chu-montpellier.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2026
• First Posted: March 24, 2026
• Study Start: July 29, 2024
• Primary Completion (Estimated): July 29, 2027
• Study Completion (Estimated): July 29, 2027
• Last Updated: March 24, 2026

Record last verified: 2026-03

Locations

FR (1)