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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07685184
Acronym
TRAUMA PAIN
Enrollment
600
Registered
2026-07-06
Start date
2026-07-01
Completion date
2028-12-01
Last updated
2026-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Traumatic Chronic Pain

Keywords

Post traumatic Chronic Pain, Orthopedic Trauma Surgery, Biopsychosocial model

Brief summary

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.

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.

Interventions

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

Sponsors

University Hospital, Montpellier
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Chronic Post-traumatic PainMore than 3 months post-traumaPresence 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).

Secondary

MeasureTime frameDescription
Visual Analog Scale (VAS) Pain ScoreFrom hospital admission until 6 months post-traumaPain intensity assessed using a visual analog scale (VAS). Scores range from 0 (no pain) to 10 (worst imaginable pain).
Injury Severity Score (ISS)Baseline (At hospital admission, day 0)Severity of traumatic injuries assessed using the Injury Severity Score. Scores range from 1 (minor injury) to 75 (most severe injury).
Pain Catastrophizing ProfileBaseline (At hospital admission, day 0)Pain catastrophizing assessed using the Pain Catastrophizing Scale (PCS). Scores range from 0 (no catastrophizing) to 52 (maximum catastrophizing).
Trait Anxiety (STAI-Trait)Baseline (At hospital admission, day 0)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).
Anxiety Intensity (Visual Analog Scale)From hospital admission through 6 months post-traumaState anxiety intensity assessed using a Visual Analog Scale (VAS). Scores range from 0 (no anxiety) to 10 (worst imaginable anxiety).
Neuropathic Pain Characteristics (DN4 Questionnaire)During hospitalization and at 3 and 6 months post-traumaNeuropathic pain characteristics assessed using the DN4 questionnaire. Scores range from 0 (no neuropathic pain) to 10 (definite neuropathic pain).
Brief Pain Inventory (BPI)At 3 and 6 months post-traumaPain 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).
Post-Traumatic Stress Symptoms (PCL-5)At 3 and 6 months post-traumaPost-traumatic stress symptoms assessed with the PCL-5 questionnaire. Scores range from 0 (no symptoms) to 80 (severe symptoms).
Opioid Misuse (POMI)At 3 and 6 months post-traumaOpioid misuse assessed with the POMI questionnaire. Scores range from 0 (no misuse) to 6 (high risk of misuse).
Quality of Life (SF-12)At 3 and 6 months post-traumaQuality 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.
Anxiety and Depression (HADS)At 3 and 6 months post-traumaAnxiety 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.
Serum BDNF ConcentrationFrom admission (before surgery ) until discharge (from day 1 to day 28)Serum concentration of Brain-Derived Neurotrophic Factor measured during hospitalization.

Contacts

CONTACTSophie Bringuier, PhD
s-bringuierbranchereau@chu-montpellier.fr+33467338661
CONTACTLucas Deffontis, MD, MSc
l-deffontis@chu-montpellier.fr+33467338256

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 7, 2026