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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| Chronic limb pain at 3 months | 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. | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Chronic limb pain at 6 months | 2. Chronic Limb Pain at 6 Months Secondary Outcome Measure: Presence of chronic limb pain at 6 months following injury Description: Persistent or recurrent limb pain defined as an average Numeric Rating Scale (NRS) score ≥3 (0-10 scale) during the preceding 7 days at the 6-month follow-up visit. Participants will be categorized as: Yes - chronic limb pain present (NRS ≥3) No - chronic limb pain absent (NRS <3) |
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Inclusion Criteria:
Exclusion Criteria:
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This study includes adults with acute combat-related extremity trauma presenting to participating trauma and rehabilitation centers in Ukraine.
Eligible participants have upper and/or lower limb injuries resulting from combat-related mechanisms, including blunt trauma, penetrating (ballistic or shrapnel) injuries, blast-related injuries, hybrid (blast plus fragment) injuries, and traumatic amputations (partial or complete).
Participants must be enrolled within 72 hours of injury and report acute limb pain with a Numeric Rating Scale (NRS) score ≥3 at baseline.
The study population represents a real-world cohort of combat-injured adults at risk for persistent limb pain, neuropathic pain, residual limb pain, and phantom limb pain.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Superhumans War Trauma Center | Lviv | Ukraine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41376178 | Result | Burmistr I, Zaslansky R, Dmytriiev D, Kopf A. The Total Pain in Ukraine Study: How Does War Affect Civilians With a History of Chronic Pain? An Observational Study. Eur J Pain. 2026 Jan;30(1):e70185. doi: 10.1002/ejp.70185. |
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De-identified individual participant data underlying the published results will be made available to qualified researchers upon reasonable request. Data will include baseline kinematics variables, pain measures (NRS), pain extent, DN4 scores, and mechanical pain thresholds (von Frey), including amputation subgroup outcomes where applicable.
Data will be shared after approval of a research proposal and execution of a data use agreement. No identifiable information will be disclosed. Data will be available beginning 6 months after publication of the primary results.
Beginning 6 months after publication of the primary results and available for 5 years thereafter.
De-identified data will be available to qualified researchers upon approval of a research proposal and signing of a data use agreement. Data will be shared securely; no identifiable information will be provided.
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| 6 months (180 ± 21 days) after injury |
| Pain Intensity Over Time (Continuous NRS Score) | Secondary Outcome Measure: Pain intensity measured using the Numeric Rating Scale (0-10) Description: Pain intensity assessed using a standardized 11-point Numeric Rating Scale (0 = no pain; 10 = worst imaginable pain). The mean NRS score at each follow-up visit will be analyzed as a continuous variable. | 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 | Pain distribution recorded using standardized digital limb body maps. Pain extent will be quantified using digital planimetry and expressed as percentage (%) of total limb surface area. | 6 weeks (±7 days), 3 months (90 ± 14 days), and 6 months (180 ± 21 days) after injury |
| ID | Term |
|---|---|
| D010591 | Phantom Limb |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D010149 | Pain, Postoperative |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D010146 | Pain |
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