NCT07491354

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 400 (estimated)
• Sponsor: University Hospital, Montpellier · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Post Traumatic Chronic Pain

Interventions

Type	Name	Description
OTHER	biological collection of residual peripheral venous blood samples	use of samples from this collection for BDNF (Brain-Derived Neurotrophic Factor) analysis
OTHER	collection of data from medical records	collection of data from medical records

Timeline

• Start date: 2024-07-29
• Primary completion: 2027-07-29
• Completion: 2027-07-29
• First posted: 2026-03-24
• Last updated: 2026-03-24

Locations

1 site across 1 country: France