About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial 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.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
Neuropathic pain phenotype
Presence of neuropathic pain features defined as DN4 score ≥4.
Sponsors and contacts
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