Post Traumatic Chronic PainTRAUMA PAINNCT07685184
The Biopsychosocial Model to Identify Risk Factors for Chronic Postoperative Pain in Orthopedic Trauma Surgery Patients
An observational study of Post Traumatic Chronic Pain, run by University Hospital, Montpellier.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Traumatic Chronic Pain
- What is being tested?
- • biological collection
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- Jul 2026to Dec 2028
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients admitted for orthopedic trauma surgery following traumatic fracture
Who may be able to join
- 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
Who cannot join
- Patient unable to exercise consent
- Patients unable to complete the self reported assessment questionnaires
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
- Conditions
- Post Traumatic Chronic Pain
- Being tested
- • biological collection
- Keywords
- Post traumatic Chronic Pain, Orthopedic Trauma Surgery, Biopsychosocial model
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
• biological collectionBiological
- 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
| Study group | Role | What they receive |
|---|---|---|
| TRAUMA-PAIN SURGERY Cohort | This cohort includes adult patients undergoing orthopedic trauma surgery for traumatic fractures Receives: Biological: • biological collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: More than 3 months post-trauma
Secondary outcomes (12)
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).
Measured: From hospital admission until 6 months post-trauma
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).
Measured: Baseline (At hospital admission, day 0)
Pain Catastrophizing Profile
Pain catastrophizing assessed using the Pain Catastrophizing Scale (PCS). Scores range from 0 (no catastrophizing) to 52 (maximum catastrophizing).
Measured: Baseline (At hospital admission, day 0)
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).
Measured: Baseline (At hospital admission, day 0)
Anxiety Intensity (Visual Analog Scale)
State anxiety intensity assessed using a Visual Analog Scale (VAS). Scores range from 0 (no anxiety) to 10 (worst imaginable anxiety).
Measured: From hospital admission through 6 months post-trauma
Neuropathic Pain Characteristics (DN4 Questionnaire)
Neuropathic pain characteristics assessed using the DN4 questionnaire. Scores range from 0 (no neuropathic pain) to 10 (definite neuropathic pain).
Measured: During hospitalization and at 3 and 6 months post-trauma
Brief Pain Inventory (BPI)
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).
Measured: At 3 and 6 months post-trauma
Post-Traumatic Stress Symptoms (PCL-5)
Post-traumatic stress symptoms assessed with the PCL-5 questionnaire. Scores range from 0 (no symptoms) to 80 (severe symptoms).
Measured: At 3 and 6 months post-trauma
Opioid Misuse (POMI)
Opioid misuse assessed with the POMI questionnaire. Scores range from 0 (no misuse) to 6 (high risk of misuse).
Measured: At 3 and 6 months post-trauma
Quality of Life (SF-12)
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.
Measured: At 3 and 6 months post-trauma
Anxiety and Depression (HADS)
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.
Measured: At 3 and 6 months post-trauma
Serum BDNF Concentration
Serum concentration of Brain-Derived Neurotrophic Factor measured during hospitalization.
Measured: From admission (before surgery ) until discharge (from day 1 to day 28)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study startJul 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Traumatic Chronic PainStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07685184
- Sponsor's protocol ID
- TRAUMA PAIN Surgery
- Acronym
- TRAUMA PAIN
- Status last verified
- Jun 2026
- First submitted
- 21 Jun 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Biopsychosocial Model to Identify Risk Factors for Chronic Postoperative Pain in Orthopedic Trauma Surgery Patients
- ClinicalTrials.gov ID
- NCT07685184
- Acronym / sponsor ID
- TRAUMA PAIN / TRAUMA PAIN Surgery
- Conditions
- Post Traumatic Chronic Pain
- Keywords
- Post traumatic Chronic Pain, Orthopedic Trauma Surgery, Biopsychosocial model
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Jul 2026 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 6 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TRAUMA-PAIN SURGERY Cohort | – | Biological: • biological collectionThis cohort includes adult patients undergoing orthopedic trauma surgery for traumatic fractures |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients admitted for orthopedic trauma surgery following traumatic fracture
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Patient unable to exercise consent
- Patients unable to complete the self reported assessment questionnaires
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| • 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 | Biological | TRAUMA-PAIN SURGERY Cohort |
Primary outcome
Chronic Post-traumatic Pain
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).
12 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Post Traumatic Chronic Pain, run by University Hospital, Montpellier.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sophie Bringuier, PhD (+33467338661, s-bringuierbranchereau@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chronic Post-traumatic Pain (time frame: More than 3 months post-trauma). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.