The Biopsychosocial Model to Identify Risk Factors for Chronic Post-traumatic Pain in ICU Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: biological collection of residual peripheral venous blood samples, collection of data from medical records.
- Who it may be relevant to
- Registry conditions: Post Traumatic Chronic Pain. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- 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
Primary outcome measures
- Chronic post-traumatic pain [Time frame: more than 3 months post-trauma]
Secondary outcome measures (12)
- Behavioral Pain Scale (BPS) Score [Time frame: From ICU admission until extubation]
- Visual Analog Scale (VAS) Pain Score [Time frame: From hospital admission until 6 months post-trauma]
- Injury Severity Score (ISS) [Time frame: At ICU admission]
- Pain Catastrophizing Profile [Time frame: During ICU stay up to 28 days]
- Trait Anxiety (STAI-Trait) [Time frame: Once during ICU stay (up to 28 days) when the patient is conscious and able to self-report]
- Anxiety Intensity (Visual Analog Scale) [Time frame: From hospital admission through 6 months post-trauma]
- Neuropathic Pain Characteristics (DN4 Questionnaire) [Time frame: During ICU stay and at 3 and 6 months post-trauma]
- Brief Pain Inventory (BPI) [Time frame: At 3 and 6 months post-trauma after hospital discharge]
- Post-Traumatic Stress Symptoms (PCL-5) [Time frame: 3 and 6 months post-trauma]
- Opioid Misuse (POMI) [Time frame: 3 and 6 months post-trauma]
- Quality of Life (SF-12) [Time frame: 3 and 6 months post-trauma]
- Anxiety and Depression (HADS) [Time frame: 3 and 6 months post-trauma]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Department of Anesthesiology and critical care, Lapeyronie University Hospital — Montpellier
Identifiers
NCT: NCT07491354 · 2025-07-324