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Enrolling by invitation NCT07432685

Kinematics-Based Prediction of Chronic Pain After Combat-Related Extremity Trauma

— Observational Residual Limb Pain Post-Traumatic Limb Pain Extremity Trauma Combat-Related Limb Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Residual Limb Pain, Post-Traumatic Limb Pain, Extremity Trauma, Combat-Related Limb Injury. Basic parameters: 18 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Ukraine
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

KIN-LIMB Protocol V1.0. KIN-LIMB: Kinematics-Based Prediction of Chronic Pain After Combat-Related Extremity Trauma

Overview

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.

Detailed description

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.

Primary outcome measures

  • Chronic limb pain at 3 months [Time frame: 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).]
Secondary outcome measures (3)
  • Chronic limb pain at 6 months [Time frame: 6 months (180 ± 21 days) after injury]
  • Pain Intensity Over Time (Continuous NRS Score) [Time frame: 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 [Time frame: 6 weeks (±7 days), 3 months (90 ± 14 days), and 6 months (180 ± 21 days) after injury]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • Inability to complete follow-up assessments
  • Severe cognitive impairment preventing informed consent
  • Declines participation

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Ukraine · 1 center
  • Superhumans War Trauma Center — Lviv

Publications

  • 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. PMID 41376178

Identifiers

NCT: NCT07432685 · 091302026

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗