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Clinical Trial NCT07424248 (TBI-Pain) for Pain, Chronic Pain, Chronic Pain Due to Injury is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Chronic Pain After Combat-Related Traumatic Brain Injury (cTBI-Pain Study) A Prospective Cohort Study of Pain Chronification After Combat-Related Traumatic Brain Injury 100 Observational
Clinical Trial NCT07424248 (TBI-Pain) is an observational study for Pain, Chronic Pain, Chronic Pain Due to Injury and is currently not yet recruiting. Enrollment is planned to begin on 15 February 2026 and continue until the study accrues 100 participants. Led by Charitable Organisation Charitable Fund Superhumans (Co Cf Superhumans), this study is expected to complete by 15 December 2026. The latest data from ClinicalTrials.gov was last updated on 24 February 2026.
Brief 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 moderate combat-related TBI. Adults will be enrolled within 14 days of injury and followed for 6 months. Th...Show More
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), ...Show More
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
Conditions
PainChronic PainChronic Pain Due to InjuryOther Study IDs
- TBI-Pain
- 09v313022026
NCT ID Number
Start Date (Actual)
2026-02-15
Last Update Posted
2026-02-24
Completion Date (Estimated)
2026-12-15
Enrollment (Estimated)
100
Study Type
Observational
Status
Not yet recruiting
Keywords
Combat-related traumatic brain injury
cTBI
Blast injury
Chronic pain
Neuropathic pain
Sleep disturbance
Pain prediction
Military trauma
cTBI
Blast injury
Chronic pain
Neuropathic pain
Sleep disturbance
Pain prediction
Military trauma
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
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. | N/A |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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. | From injury to 3 months (±2 weeks) post-injury. |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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. | 6 months (±3 weeks) after injury |
Neuropathic pain phenotype | Presence of neuropathic pain features defined as DN4 score ≥4. | 3 and 6 months after injury |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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
- 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
Charitable Organisation Charitable Fund Superhumans (Co Cf Superhumans)Study Central Contact
Contact: Dmytro Dmytriiev, PhD.Professor, +380674309449, [email protected]
1 Study Locations in 1 Countries
Superhumans War Trauma Center, Lviv, Ukraine