The Biopsychosocial Model to Identify Risk Factors for Chronic Postoperative Pain in Orthopedic Trauma Surgery 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.
- 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
- Center list to be confirmed — check the primary protocol.
- 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 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
Primary outcome measures
- Chronic Post-traumatic Pain [Time frame: More than 3 months post-trauma]
Secondary outcome measures (12)
- Visual Analog Scale (VAS) Pain Score [Time frame: From hospital admission until 6 months post-trauma]
- Injury Severity Score (ISS) [Time frame: Baseline (At hospital admission, day 0)]
- Pain Catastrophizing Profile [Time frame: Baseline (At hospital admission, day 0)]
- Trait Anxiety (STAI-Trait) [Time frame: Baseline (At hospital admission, day 0)]
- Anxiety Intensity (Visual Analog Scale) [Time frame: From hospital admission through 6 months post-trauma]
- Neuropathic Pain Characteristics (DN4 Questionnaire) [Time frame: During hospitalization and at 3 and 6 months post-trauma]
- Brief Pain Inventory (BPI) [Time frame: At 3 and 6 months post-trauma]
- Post-Traumatic Stress Symptoms (PCL-5) [Time frame: At 3 and 6 months post-trauma]
- Opioid Misuse (POMI) [Time frame: At 3 and 6 months post-trauma]
- Quality of Life (SF-12) [Time frame: At 3 and 6 months post-trauma]
- Anxiety and Depression (HADS) [Time frame: At 3 and 6 months post-trauma]
- Serum BDNF Concentration [Time frame: From admission (before surgery ) until discharge (from day 1 to day 28)]
Eligibility criteria
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
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
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07685184 · TRAUMA PAIN Surgery