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

NCT07685184 | Not Yet Recruiting

• 1 other identifier: TRAUMA PAIN Surgery
• Study Type: observational
• Target: 600
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Post Traumatic Chronic Pain

Keywords

Post traumatic Chronic Pain; Orthopedic Trauma Surgery; Biopsychosocial model

Outcome Measures

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).

  More than 3 months post-trauma

Secondary Outcomes (12)

• Visual Analog Scale (VAS) Pain Score

  From hospital admission until 6 months post-trauma

• Injury Severity Score (ISS)

  Baseline (At hospital admission, day 0)

• Pain Catastrophizing Profile

  Baseline (At hospital admission, day 0)

• Trait Anxiety (STAI-Trait)

  Baseline (At hospital admission, day 0)

• Anxiety Intensity (Visual Analog Scale)

  From hospital admission through 6 months post-trauma

Study Arms (1)

TRAUMA-PAIN SURGERY Cohort

This cohort includes adult patients undergoing orthopedic trauma surgery for traumatic fractures

Biological: • biological collection

Interventions

• biological collection BIOLOGICAL

* 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

TRAUMA-PAIN SURGERY Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients admitted for orthopedic trauma surgery following traumatic fracture

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

Peripheral venous blood samples are collected and serum is isolated and stored for biomarker analyses.

Central Study Contacts

Sophie Bringuier, PhD

CONTACT

+33467338661; s-bringuierbranchereau@chu-montpellier.fr

Lucas Deffontis, MD, MSc

CONTACT

+33467338256; l-deffontis@chu-montpellier.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2026
• First Posted: July 6, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: July 6, 2026

Record last verified: 2026-06