Health TrialsbyHealthPanel

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

ConditionPost Traumatic Chronic Pain
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Montpellier

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • biological collection of residual peripheral venous blood samples

    Other intervention

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

  • collection of data from medical records

    Other intervention

    collection of data from medical records

Treatment groups

400 Participants
are divided into 1 treatment group
Group A: TRAUMApain ICU Cohort2 interventions

Trial outcomes

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).

Time frame
more than 3 months post-trauma

Secondary outcomes

1

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).

Time frame
From ICU admission until extubation
2

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).

Time frame
From hospital admission until 6 months post-trauma
3

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).

Time frame
At ICU admission
4

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).

Time frame
During ICU stay up to 28 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Montpellier

Lead sponsor

Source ClinicalTrials.gov
Apply now