Chronic Pain After Combat-Related Traumatic Brain Injury (cTBI-Pain Study) A Prospective Cohort Study of Pain Chronification After Combat-Related Traumatic Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Clinically significant chronic pain at 3 months after injury.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
结局指标
主要结局
Clinically significant chronic pain at 3 months after injury.
时间窗: 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.
次要结局
- Clinically significant chronic pain at 6 months(6 months (±3 weeks) after injury)
- Neuropathic pain phenotype(3 and 6 months after injury)