The Biopsychosocial Model to Identify Risk Factors for Chronic Postoperative Pain in Orthopedic Trauma Surgery Patients (TRAUMA PAIN)

This study aims to assess multidimensional risk factors for chronic post-traumatic pain in orthopedic trauma surgery 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: Not yet recruiting
• Conditions: Post Traumatic Chronic Pain
• Intervention / Treatment: Biological: • biological collection

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.

Traumatic fractures requiring surgical treatment are among the most common causes of severe acute pain and may result in persistent pain despite fracture healing and satisfactory surgical outcomes. Chronic post-traumatic pain following orthopedic trauma surgery is associated with prolonged functional impairment, delayed return to work, psychological distress, and decreased quality of life.

Current evidence suggests that chronic post-traumatic pain results from a complex interaction between injury-related characteristics, biological vulnerability, therapeutic management, and psychosocial factors. However, these multidimensional determinants remain incompletely understood in orthopedic trauma populations.

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. Fracture-related characteristics, including fracture location, injury severity, surgical management, analgesic strategies, and rehabilitation pathways, 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): 600

Contacts and Locations

• Study Contact: Name: Sophie Bringuier, PhD; Phone Number: +33467338661; Email: s-bringuierbranchereau@chu-montpellier.fr
• Study Contact Backup: Name: Lucas Deffontis, MD, MSc; Phone Number: +33467338256; Email: l-deffontis@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 for orthopedic trauma surgery following traumatic fracture

Description

Inclusion Criteria:

• Adult patients aged 18 years or older
• Surgical treatment for a traumatic fracture
• Admission to an orthopedic trauma surgery department
• Ability to participate in follow-up assessments
• Informed consent

Exclusion Criteria:

• Patient unable to exercise consent
• Patients unable to complete the self reported assessment questionnaires

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
TRAUMA-PAIN SURGERY Cohort; This cohort includes adult patients undergoing orthopedic trauma surgery for traumatic fractures	Biological: • biological collection; biological collection of residual peripheral venous blood samples; use of samples from this collection for BDNF (Brain-Derived Neurotrophic Factor) analysis; collection of data from medical records; collection of psychosocial and patient-reported outcome data

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
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).	Baseline (At hospital admission, day 0)
Pain Catastrophizing Profile	Pain catastrophizing assessed using the Pain Catastrophizing Scale (PCS). Scores range from 0 (no catastrophizing) to 52 (maximum catastrophizing).	Baseline (At hospital admission, day 0)
Trait Anxiety (STAI-Trait)	Trait anxiety assessed using the State-Trait Anxiety Inventory - Trait subscale (STAI-Trait). Scores range from 20 (low trait anxiety) to 80 (high trait anxiety).	Baseline (At hospital admission, day 0)
Anxiety Intensity (Visual Analog Scale)	State anxiety intensity assessed using a Visual Analog Scale (VAS). 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. Scores range from 0 (no neuropathic pain) to 10 (definite neuropathic pain).	During hospitalization and at 3 and 6 months post-trauma
Brief Pain Inventory (BPI)	Pain assessed with the Brief Pain Inventory (BPI), including pain severity and pain interference subscales. Both subscale scores range from 0 (no pain/no interference) to 10 (worst pain/maximum interference).	At 3 and 6 months post-trauma
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).	At 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).	At 3 and 6 months post-trauma
Quality of Life (SF-12)	Quality of life assessed using the SF-12 questionnaire. Physical Component Summary (PCS) and Mental Component Summary (MCS) scores range from 0 to 100. Higher scores indicate better quality of life.	At 3 and 6 months post-trauma
Anxiety and Depression (HADS)	Anxiety and depression assessed using the Hospital Anxiety and Depression Scale (HADS). Each subscale ranges from 0 to 21. Total score ranges from 0 to 42.	At 3 and 6 months post-trauma
Serum BDNF Concentration	Serum concentration of Brain-Derived Neurotrophic Factor measured during hospitalization.	From admission (before surgery ) until discharge (from day 1 to day 28)

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: June 21, 2026
• First Submitted That Met QC Criteria: July 1, 2026
• First Posted (Actual): July 6, 2026

Study Record Updates

• Last Update Posted (Actual): July 6, 2026
• Last Update Submitted That Met QC Criteria: July 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Biopsychosocial model; Post traumatic Chronic Pain; Orthopedic Trauma Surgery
• Other Study ID Numbers: TRAUMA PAIN Surgery

Drug and device information, study documents

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