Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT07432685

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

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.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

Residual Limb Pain Chronic Pain Chronic Pain Due to Injury Combat-Related Limb Injury Extremity Trauma Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Phantom Limb Phantom Limb Pain Phantom Limb Pain After Amputation Post-Traumatic Limb Pain Postoperative Complications Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Superhumans War Trauma Center

Lviv, Ukraine

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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).

    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.

Secondary outcomes

  1. Chronic limb pain at 6 months

    Time frame: 6 months (180 ± 21 days) after injury

    • 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)

  2. 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

    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.

  3. 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

    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.

Sponsors and collaborators

Lead sponsor

Charitable Organisation Charitable Fund Superhumans (Co Cf Superhumans)

Other

Registry information

Official study title

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

Acronym: KIN-LIMB

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Feb 25, 2026
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.