Health TrialsbyHealthPanel

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

ConditionPost Traumatic Chronic Pain
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Montpellier

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patient unable to exercise consent

Patients unable to complete the self reported assessment questionnaires

Trial population

Adult patients admitted for orthopedic trauma surgery following traumatic fracture

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • • biological collection

    Biological/Vaccine

    * 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

Treatment groups

600 Participants
are divided into 1 treatment group
Group A: TRAUMA-PAIN SURGERY Cohort1 intervention

Trial outcomes

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).

Time frame
More than 3 months post-trauma

Secondary outcomes

1

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).

Time frame
From hospital admission until 6 months post-trauma
2

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).

Time frame
Baseline (At hospital admission, day 0)
3

Pain Catastrophizing Profile

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)
4

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).

Time frame
Baseline (At hospital admission, day 0)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Montpellier

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: