PainTBI-PainNCT07424248
Chronic Pain After Combat-Related Traumatic Brain Injury (cTBI-Pain Study) A Prospective Cohort Study of Pain Chronification After Combat-Related Traumatic Brain Injury
An observational study of Pain and Chronic Pain, run by Charitable Organisation Charitable Fund Superhumans (Co Cf Superhumans) at 1 site in Ukraine.
Trial summary
Combat-related traumatic brain injury (cTBI), particularly blast-related injury, is frequently associated with the development of persistent and disabling chronic pain. This prospective observational cohort study aims to determine the incidence, phenotypes, and early predictors of chronic pain following mild to… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Pain, Chronic Pain, Chronic Pain Due to Injury
- How many people
- 100 participants
- Where
- 1 siteUkraine
- Study dates
- 15 Feb 2026to 15 Dec 2026
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Adults aged 18-60 years with mild to moderate combat-related traumatic brain injury (blast, impact, or combined mechanism) presenting to participating trauma and rehabilitation centers in Ukraine. Participants will be enrolled within 14 days of injury and followed prospectively for 6 months to assess the development of chronic pain and related psychological and functional outcomes.
Who may be able to join
- Age 18 to 60 years
- Combat-related traumatic brain injury (blast, impact, or combined mechanism)
- Mild to moderate traumatic brain injury
- Enrollment within 14 days after injury
- Ability to provide written informed consent
Who cannot join
- Severe traumatic brain injury with prolonged impaired consciousness
- Pre-existing severe psychiatric disorder unrelated to trauma
- Chronic pain condition predating the traumatic brain injury
- Inability to complete follow-up assessments
- Severe medical condition limiting participation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Combat-related traumatic brain injury (cTBI), particularly blast-related injury, is frequently associated with the development of persistent and disabling chronic pain. This prospective observational cohort study aims to determine the incidence, phenotypes, and early predictors of chronic pain following mild to moderate combat-related TBI. Adults will be enrolled within 14 days of injury and followed for 6 months. The primary endpoint is clinically significant chronic pain at 3 months, defined by pain intensity and functional interference. The study will evaluate clinical, psychological, and physiological factors to develop and internally validate a prognostic model for chronic pain risk after cTBI.
Read the detailed description
Combat-related traumatic brain injury (cTBI), particularly blast-associated injury, is a major contributor to the development of chronic pain syndromes in military populations. Pain following cTBI may present as chronic post-traumatic headache, cervicogenic pain, neuropathic pain, or widespread pain associated with central sensitization. The interaction between neuronal injury, psychological stress (including PTSD), sleep disturbance, and associated peripheral trauma creates a high-risk environment for pain chronification.
This prospective observational cohort study will enroll adults with mild to moderate combat-related traumatic brain injury within 14 days of injury. Participants will undergo standardized clinical, psychometric, and physiological assessments during the acute phase and will be followed longitudinally at 6 weeks, 3 months, and 6 months.
Pain intensity will be assessed using the Numerical Rating Scale (NRS) and the Brief Pain Inventory (BPI). Neuropathic pain features will be evaluated using DN4, and central sensitization symptoms using the Central Sensitization Inventory (CSI). Psychological factors including PTSD (PCL-5), depression (PHQ-9), anxiety (GAD-7), and pain catastrophizing (PCS) will be assessed. Sleep disturbance will be evaluated using the Insomnia Severity Index (ISI). Functional outcomes will be measured using WHODAS 2.0 and PROMIS Physical Function. A subgroup of participants will undergo physiological testing, including heart rate variability (HRV) and quantitative sensory testing (QST).
The primary endpoint is clinically significant chronic pain at 3 months, defined as NRS ≥4 and/or BPI interference score ≥4. Secondary outcomes include neuropathic pain phenotype, functional impairment, psychological outcomes, and persistent analgesic use at 6 months.
Multivariable regression modeling, including logistic regression and penalized methods (LASSO), will be used to identify independent predictors of chronic pain. Internal validation will be performed using bootstrapping techniques. Model performance will be evaluated using ROC-AUC and calibration metrics.
The study aims to develop a clinically applicable risk prediction model to identify individuals at high risk for chronic pain following combat-related TBI and to inform early preventive and rehabilitative interventions.
- Conditions
- Pain, Chronic Pain, Chronic Pain Due to Injury
- Keywords
- Combat-related traumatic brain injury, cTBI, Blast injury, Chronic pain, Neuropathic pain, Sleep disturbance, Pain prediction, Military trauma
- Medical subject headings
- Pain, Chronic Pain, Blast Injuries, Neuralgia, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Combat-Related TBI Cohort | Adults aged 18-60 years with mild to moderate combat-related traumatic brain injury enrolled within 14 days of injury. Participants will undergo standardized clinical, psychological, and pain assessments and will be followed prospectively for 6 months to evaluate the development of chronic pain. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinically significant chronic pain at 3 months after injury.
Clinically significant chronic pain is defined as pain intensity ≥4 on the 0-10 Numerical Rating Scale (NRS) and/or pain interference score ≥4 on the Brief Pain Inventory (BPI) at 3 months post-injury. The proportion of participants meeting this definition will be calculated, and predictors of chronic pain will be evaluated using multivariable modeling.
Measured: From injury to 3 months (±2 weeks) post-injury.
Secondary outcomes (2)
Clinically significant chronic pain at 6 months
Presence of chronic pain defined as NRS ≥4 and/or BPI interference score ≥4 at 6 months post-injury.
Measured: 6 months (±3 weeks) after injury
Neuropathic pain phenotype
Presence of neuropathic pain features defined as DN4 score ≥4.
Measured: 3 and 6 months after injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start15 Feb 2026 (estimated)
- Primary completion15 Feb 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- 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
- 100 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Charitable Organisation Charitable Fund Superhumans (Co Cf Superhumans)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07424248
- Sponsor's protocol ID
- 09v313022026
- Acronym
- TBI-Pain
- Status last verified
- Feb 2026
- First submitted
- 14 Feb 2026
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be publicly posted due to privacy considerations related to military trauma data. De-identified data may be made available upon reasonable request, subject to approval by the study steering committee and execution of a data use agreement.
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Pain After Combat-Related Traumatic Brain Injury (cTBI-Pain Study) A Prospective Cohort Study of Pain Chronification After Combat-Related Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT07424248
- Acronym / sponsor ID
- TBI-Pain / 09v313022026
- Conditions
- Pain, Chronic Pain, Chronic Pain Due to Injury
- Keywords
- Combat-related traumatic brain injury, cTBI, Blast injury, Chronic pain, Neuropathic pain, Sleep disturbance, Pain prediction, Military trauma
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Charitable Organisation Charitable Fund Superhumans (Co Cf Superhumans)University, hospital or other
- Study start
- 15 Feb 2026 (estimated)
- Primary completion
- 15 Feb 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 20 Feb 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.
Combat-related traumatic brain injury (cTBI), particularly blast-related injury, is frequently associated with the development of persistent and disabling chronic pain. This prospective observational cohort study aims to determine the incidence, phenotypes, and early predictors of chronic pain following mild to moderate combat-related TBI. Adults will be enrolled within 14 days of injury and followed for 6 months. The primary endpoint is clinically significant chronic pain at 3 months, defined by pain intensity and functional interference. The study will evaluate clinical, psychological, and physiological factors to develop and internally validate a prognostic model for chronic pain risk after cTBI.
Detailed description
Combat-related traumatic brain injury (cTBI), particularly blast-associated injury, is a major contributor to the development of chronic pain syndromes in military populations. Pain following cTBI may present as chronic post-traumatic headache, cervicogenic pain, neuropathic pain, or widespread pain associated with central sensitization. The interaction between neuronal injury, psychological stress (including PTSD), sleep disturbance, and associated peripheral trauma creates a high-risk environment for pain chronification.
This prospective observational cohort study will enroll adults with mild to moderate combat-related traumatic brain injury within 14 days of injury. Participants will undergo standardized clinical, psychometric, and physiological assessments during the acute phase and will be followed longitudinally at 6 weeks, 3 months, and 6 months.
Pain intensity will be assessed using the Numerical Rating Scale (NRS) and the Brief Pain Inventory (BPI). Neuropathic pain features will be evaluated using DN4, and central sensitization symptoms using the Central Sensitization Inventory (CSI). Psychological factors including PTSD (PCL-5), depression (PHQ-9), anxiety (GAD-7), and pain catastrophizing (PCS) will be assessed. Sleep disturbance will be evaluated using the Insomnia Severity Index (ISI). Functional outcomes will be measured using WHODAS 2.0 and PROMIS Physical Function. A subgroup of participants will undergo physiological testing, including heart rate variability (HRV) and quantitative sensory testing (QST).
The primary endpoint is clinically significant chronic pain at 3 months, defined as NRS ≥4 and/or BPI interference score ≥4. Secondary outcomes include neuropathic pain phenotype, functional impairment, psychological outcomes, and persistent analgesic use at 6 months.
Multivariable regression modeling, including logistic regression and penalized methods (LASSO), will be used to identify independent predictors of chronic pain. Internal validation will be performed using bootstrapping techniques. Model performance will be evaluated using ROC-AUC and calibration metrics.
The study aims to develop a clinically applicable risk prediction model to identify individuals at high risk for chronic pain following combat-related TBI and to inform early preventive and rehabilitative interventions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combat-Related TBI Cohort | – | –Adults aged 18-60 years with mild to moderate combat-related traumatic brain injury enrolled within 14 days of injury. Participants will undergo standardized clinical, psychological, and pain assessments and will be followed prospectively for 6 months to evaluate the development of chronic pain. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Adults aged 18-60 years with mild to moderate combat-related traumatic brain injury (blast, impact, or combined mechanism) presenting to participating trauma and rehabilitation centers in Ukraine. Participants will be enrolled within 14 days of injury and followed prospectively for 6 months to assess the development of chronic pain and related psychological and functional outcomes.
Key inclusion criteria (5 listed)
- Age 18 to 60 years
- Combat-related traumatic brain injury (blast, impact, or combined mechanism)
- Mild to moderate traumatic brain injury
- Enrollment within 14 days after injury
- Ability to provide written informed consent
Key exclusion criteria (5 listed)
- Severe traumatic brain injury with prolonged impaired consciousness
- Pre-existing severe psychiatric disorder unrelated to trauma
- Chronic pain condition predating the traumatic brain injury
- Inability to complete follow-up assessments
- Severe medical condition limiting participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinically significant chronic pain at 3 months after injury.
Time frame: From injury to 3 months (±2 weeks) post-injury.
Clinically significant chronic pain is defined as pain intensity ≥4 on the 0-10 Numerical Rating Scale (NRS) and/or pain interference score ≥4 on the Brief Pain Inventory (BPI) at 3 months post-injury. The proportion of participants meeting this definition will be calculated, and predictors of chronic pain will be evaluated using multivariable modeling.
2 secondary outcomes
Clinically significant chronic pain at 6 months
Time frame: 6 months (±3 weeks) after injury
Neuropathic pain phenotype
Time frame: 3 and 6 months after injury
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 Feb 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be publicly posted due to privacy considerations related to military trauma data. De-identified data may be made available upon reasonable request, subject to approval by the study steering committee and execution of a data use agreement.
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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.
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 Pain and Chronic Pain, run by Charitable Organisation Charitable Fund Superhumans (Co Cf Superhumans) at 1 site in Ukraine.
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 5 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 24 Feb 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 Ukraine. 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 Dmytro Dmytriiev, PhD.Professor (+380674309449, d.dmytriiev@superhumans.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinically significant chronic pain at 3 months after injury. (time frame: From injury to 3 months (±2 weeks) post-injury.). 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 Feb 2026; AzTrials last refreshed its copy on 8 Nov 2026.