Post Traumatic Chronic PainTRAUMA-PAINNCT07491354
The Biopsychosocial Model to Identify Risk Factors for Chronic Post-traumatic Pain in ICU Patients
An observational study of Post Traumatic Chronic Pain, run by University Hospital, Montpellier at 1 site in France.
Trial summary
This study aims to assess multidimensional risk factors for chronic post-traumatic pain in polytrauma 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… 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 of residual peripheral venous blood samples and collection of data from medical records
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- 29 Jul 2024to 29 Jul 2027
- 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 to the intensive care unit following traumatic injury, with an AIS score greater than 1 and at least one fracture, are included in this study.
Who may be able to join
- Adult patients aged 18 years or older
- Patients with an Abbreviated Injury Scale (AIS) score greater than 1
- Patients presenting with at least one documented fracture
Who cannot join
- Patients with an isolated fracture of the carpal bones
- Patients with isolated traumatic brain injury
- Patients with isolated minor facial trauma
- Patients with isolated digestive trauma
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Department of Anesthesiology and critical care, Lapeyronie University Hospital
Montpellier, 34295
Xavier XC CAPDEVILA, MD, PhD, x-capdevila@chu-montpellier.fr
Xavier XC CAPDEVILA, MD, PhD
About this study
This study aims to assess multidimensional risk factors for chronic post-traumatic pain in polytrauma 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.
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. Trauma-related characteristics, including injury mechanism, severity, and lesion location, 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 of residual peripheral venous blood samples, collection of data from medical records
- Keywords
- Post traumatic Chronic Pain, Intensive Care Units, Biopsychosocial model
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biological collection of residual peripheral venous blood samplesOther
use of samples from this collection for BDNF (Brain-Derived Neurotrophic Factor) analysis
collection of data from medical recordsOther
collection of data from medical records
| Study group | Role | What they receive |
|---|---|---|
| TRAUMApain ICU Cohort | This cohort includes adult patients admitted to the intensive care unit (ICU) for traumatic injuries. Eligible patients are aged 18 years or older, with an Abbreviated Injury Scale (AIS) score greater than 1, and have at least one documented fracture. Receives: Other: biological collection of residual peripheral venous blood samples; Other: collection of data from medical records |
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)
Behavioral Pain Scale (BPS) Score
Pain assessed using the Behavioral Pain Scale (BPS) in mechanically ventilated and intubated patients. Scores range from 3 (no pain) to 12 (maximum pain).
Measured: From ICU admission until extubation
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: At ICU admission
Pain Catastrophizing Profile
Pain catastrophizing assessed using the Pain Catastrophizing Scale (PCS) as soon as the patient is able to self-report during the ICU stay. Scores range from 0 (no catastrophizing) to 52 (maximum catastrophizing).
Measured: During ICU stay up to 28 days
Trait Anxiety (STAI-Trait)
Trait anxiety assessed using the State-Trait Anxiety Inventory - Trait subscale (STAI-Trait) as soon as the patient is conscious and able to self-report during the ICU stay. Scores range from 20 (low trait anxiety) to 80 (high trait anxiety).
Measured: Once during ICU stay (up to 28 days) when the patient is conscious and able to self-report
Anxiety Intensity (Visual Analog Scale)
State anxiety intensity assessed using a Visual Analog Scale (VAS) in non-intubated patients able to self-report during the ICU stay, and during follow-up up to 6 months post-trauma.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 as soon as the patient is able to self-report during hospitalization if pre-existing chronic pain is present, and reassessed at 3 and 6 months post-trauma in patients reporting pain.Scores range from 0 (no neuropathic pain) to 10 (definite neuropathic pain).
Measured: During ICU stay and at 3 and 6 months post-trauma
Brief Pain Inventory (BPI)
Pain assessed with the Brief Pain Inventory (BPI), including two subscales: pain severity and pain interference.
Both subscale scores range from 0 (no pain / no interference) to 10 (worst pain / maximum interference).
Measured: At 3 and 6 months post-trauma after hospital discharge
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: 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: 3 and 6 months post-trauma
Quality of Life (SF-12)
Quality of life assessed with the SF-12 questionnaire, including two component scores: Physical Component Summary (PCS) and Mental Component Summary (MCS). Scores are standardized on a 0 to 100 scale, with higher scores indicating better quality of life.
Measured: 3 and 6 months post-trauma
Anxiety and Depression (HADS)
Anxiety and depression assessed with the Hospital Anxiety and Depression Scale (HADS), including two subscales: anxiety and depression. A total score is also calculated by summing both subscales.
Each subscale score ranges from 0 to 21, and the total score ranges from 0 (no symptoms) to 42 (severe anxiety and depression).
Measured: 3 and 6 months post-trauma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start29 Jul 2024
- Primary completion29 Jul 2027 (estimated)
- Study completion29 Jul 2027 (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
- 400 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- CAPDEVILA Xavier, MD PhD, Study director, x-capdevila@chu-montpellier.fr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07491354
- Sponsor's protocol ID
- 2025-07-324
- Acronym
- TRAUMA-PAIN
- Status last verified
- Mar 2026
- First submitted
- 17 Feb 2026
- Last updated
- 24 Mar 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 24 Mar 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 Post-traumatic Pain in ICU Patients
- ClinicalTrials.gov ID
- NCT07491354
- Acronym / sponsor ID
- TRAUMA-PAIN / 2025-07-324
- Conditions
- Post Traumatic Chronic Pain
- Keywords
- Post traumatic Chronic Pain, Intensive Care Units, Biopsychosocial model
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 29 Jul 2024 (actual)
- Primary completion
- 29 Jul 2027 (estimated)
- Study completion
- 29 Jul 2027 (estimated)
- First posted
- 24 Mar 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 polytrauma 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.
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. Trauma-related characteristics, including injury mechanism, severity, and lesion location, 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 |
|---|---|---|
| TRAUMApain ICU Cohort | – | Other: biological collection of residual peripheral venous blood samples, Other: collection of data from medical recordsThis cohort includes adult patients admitted to the intensive care unit (ICU) for traumatic injuries. Eligible patients are aged 18 years or older, with an Abbreviated Injury Scale (AIS) score greater than 1, and have at least one documented fracture. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients admitted to the intensive care unit following traumatic injury, with an AIS score greater than 1 and at least one fracture, are included in this study.
Key inclusion criteria (3 listed)
- Adult patients aged 18 years or older
- Patients with an Abbreviated Injury Scale (AIS) score greater than 1
- Patients presenting with at least one documented fracture
Key exclusion criteria (4 listed)
- Patients with an isolated fracture of the carpal bones
- Patients with isolated traumatic brain injury
- Patients with isolated minor facial trauma
- Patients with isolated digestive trauma
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 of residual peripheral venous blood samplesuse of samples from this collection for BDNF (Brain-Derived Neurotrophic Factor) analysis | Other | TRAUMApain ICU Cohort |
| collection of data from medical recordscollection of data from medical records | Other | TRAUMApain ICU 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
Behavioral Pain Scale (BPS) Score
Time frame: From ICU admission until extubation
Visual Analog Scale (VAS) Pain Score
Time frame: From hospital admission until 6 months post-trauma
Injury Severity Score (ISS)
Time frame: At ICU admission
Pain Catastrophizing Profile
Time frame: During ICU stay up to 28 days
Trait Anxiety (STAI-Trait)
Time frame: Once during ICU stay (up to 28 days) when the patient is conscious and able to self-report
Anxiety Intensity (Visual Analog Scale)
Time frame: From hospital admission through 6 months post-trauma
Neuropathic Pain Characteristics (DN4 Questionnaire)
Time frame: During ICU stay and at 3 and 6 months post-trauma
Brief Pain Inventory (BPI)
Time frame: At 3 and 6 months post-trauma after hospital discharge
Post-Traumatic Stress Symptoms (PCL-5)
Time frame: 3 and 6 months post-trauma
Opioid Misuse (POMI)
Time frame: 3 and 6 months post-trauma
Quality of Life (SF-12)
Time frame: 3 and 6 months post-trauma
Anxiety and Depression (HADS)
Time frame: 3 and 6 months post-trauma
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 24 Mar 2026.
Related trials for Post Traumatic Chronic Pain
Not yet recruitingPhase 1
Simultaneous Engagement of Networks for Alleviating Pain (SENAP)
Neuropathic Pain, Postherpetic Neuralgia
Recruiting
Uncovering the Mechanism of Pain Relief by Peripheral Transcutaneous Magnetic Stimulation
Post-Surgical Pain, Chronic, Post-traumatic Pain, Chronic
Active, not recruitingObservational study
Persona OsseoTi Keel Compatibility Study (Total Knee Arthroplasty)
Knee Pain Chronic, Osteoarthritis, Knee
Not yet recruitingPhase 2
Post-traumatic Estradiol Administration and Care Evaluation (PEACE)
Chronic Musculoskeletal Pain, Sexual Assault
Recruiting
Clinical Study of Myofascial Trigger Points(MTrPs) Injection in the Treatment of Knee Osteoarthritis(OA)
Myofascial Trigger Points, Migraine
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.
CAPDEVILA Xavier, MD PhD study director
x-capdevila@chu-montpellier.fr
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post Traumatic Chronic Pain, run by University Hospital, Montpellier at 1 site in France.
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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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 24 Mar 2026.