NCT Number: NCT07685184
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: More than 3 months post-trauma
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: From hospital admission until 6 months post-trauma
Pain intensity assessed using a visual analog scale (VAS). Scores range from 0 (no pain) to 10 (worst imaginable pain).
Time frame: 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).
Time frame: Baseline (At hospital admission, day 0)
Pain catastrophizing assessed using the Pain Catastrophizing Scale (PCS). Scores range from 0 (no catastrophizing) to 52 (maximum catastrophizing).
Time frame: 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).
Time frame: From hospital admission through 6 months post-trauma
State anxiety intensity assessed using a Visual Analog Scale (VAS). Scores range from 0 (no anxiety) to 10 (worst imaginable anxiety).
Time frame: During hospitalization and at 3 and 6 months post-trauma
Neuropathic pain characteristics assessed using the DN4 questionnaire. Scores range from 0 (no neuropathic pain) to 10 (definite neuropathic pain).
Time frame: At 3 and 6 months post-trauma
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).
Time frame: At 3 and 6 months post-trauma
Post-traumatic stress symptoms assessed with the PCL-5 questionnaire. Scores range from 0 (no symptoms) to 80 (severe symptoms).
Time frame: At 3 and 6 months post-trauma
Opioid misuse assessed with the POMI questionnaire. Scores range from 0 (no misuse) to 6 (high risk of misuse).
Time frame: At 3 and 6 months post-trauma
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.
Time frame: At 3 and 6 months post-trauma
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.
Time frame: From admission (before surgery ) until discharge (from day 1 to day 28)
Serum concentration of Brain-Derived Neurotrophic Factor measured during hospitalization.
Contact information is provided by the study sponsor or research team.
Lucas Deffontis, MD, MSc
CONTACT
Sophie Bringuier, PhD
CONTACT
University Hospital, Montpellier
Other
Acronym: TRAUMA PAIN
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