KIN-LIMB Protocol V1.0. KIN-LIMB: Kinematics-Based Prediction of Chronic Pain After Combat-Related Extremity Trauma
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Chronic limb pain at 3 months
研究概览
简要总结
Combat-related extremity trauma frequently results in persistent pain, including neuropathic, residual limb, and phantom limb pain. The kinematics of injury-including energy level, direction of force, and dominant force components-may independently predict tissue deformation, nerve stress, and the transition from acute to chronic- pain. This prospective observational cohort study will assess whether kinematics-only variables predict chronic pain outcomes after combat-related upper and lower limb injuries. Pain outcomes will include pain intensity, pain extent (surface/area), neuropathic pain features, and mechanical pain sensitivity measured using von Frey filaments.
详细描述
Adults with combat-related limb trauma will be enrolled within 72 hours of injury. Baseline assessment will include a standardized kinematics classification documenting (1) energy class, (2) dominant direction of force, (3) dominant force component, and (4) kinematics severity grade (K0-K3). Participants will be followed at 6 weeks, 3 months, and 6 months. The primary endpoint is chronic limb pain at 3 months. Secondary endpoints include chronic pain at 6 months, pain area, neuropathic features, and mechanical pain thresholds using von Frey testing at standardized limb sites (injured and contralateral control). This is a non-interventional study; no treatment decisions are dictated by the protocol.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Combat-related extremity trauma involving upper and/or lower limbs
- •Blunt limb trauma
- •Penetrating limb injury (ballistic or shrapnel)
- •Blast-related limb injury
- •Hybrid injury (blast plus fragment)
- •тTraumatic amputation (partial or complete)
- •Baseline assessment performed within 72 hours of injury
- •Acute limb pain with Numeric Rating Scale (NRS) score ≥3 at baseline
- •Ability to provide informed consent
- •Ability to participate in follow-up assessments
排除标准
- •Inability to complete follow-up assessments
- •Severe cognitive impairment preventing informed consent
- •Declines participation
结局指标
主要结局
Chronic limb pain at 3 months
时间窗: Assessed at 3 months (90 days ± 14 days) after injury Pain assessment will be conducted during the scheduled 3-month follow-up visit (between Day 76 and Day 104 post-injury).
Presence of chronic limb pain at 3 months following injury Chronic limb pain is defined as persistent or recurrent pain localized to the anatomically injured limb, with an average Numeric Rating Scale (NRS) score ≥3 (0-10 scale) during the preceding 7 days at the 3-month follow-up. Pain intensity will be assessed using a standardized 11-point Numeric Rating Scale (0 = no pain; 10 = worst imaginable pain). Participants will be categorized as: Yes - chronic limb pain present (NRS ≥3) No - chronic limb pain absent (NRS \<3) The primary analysis will evaluate the association between baseline injury kinematics variables (energy class, dominant force direction, dominant force component, and kinematics severity grade K0-K3) and the presence of chronic limb pain at 3 months.
次要结局
- Chronic limb pain at 6 months(6 months (180 ± 21 days) after injury)
- Pain Intensity Over Time (Continuous NRS Score)(Baseline (within 72 hours of injury), 6 weeks (±7 days), 3 months (90 ± 14 days), and 6 months (180 ± 21 days) after injury)
- Pain extent measured as percentage of affected limb surface area(6 weeks (±7 days), 3 months (90 ± 14 days), and 6 months (180 ± 21 days) after injury)
研究者
Dmytro Dmytriiev
Professor, Chief of Science Deparment
Charitable Organisation Charitable Fund Superhumans (Co Cf Superhumans)