Kinematics-Based Prediction of Chronic Pain After Combat-Related Extremity Trauma (KIN-LIMB)

February 19, 2026 updated by: Dmytro Dmytriiev, Charitable Organisation Charitable Fund Superhumans (Co Cf Superhumans)

KIN-LIMB Protocol V1.0. KIN-LIMB: 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.

Study Overview

Status

Enrolling by invitation

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ukraine
      • Lviv, Ukraine
        • Superhumans War Trauma Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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

Outcome Measure
Measure Description
Time Frame
Chronic limb pain at 6 months
Time Frame: 6 months (180 ± 21 days) after injury

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)
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

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
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.
6 weeks (±7 days), 3 months (90 ± 14 days), and 6 months (180 ± 21 days) after injury

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charitable Organisation Charitable Fund Superhumans (Co Cf Superhumans)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 12, 2026

Primary Completion (Estimated)

December 22, 2026

Study Completion (Estimated)

December 14, 2027

Study Registration Dates

First Submitted

February 14, 2026

First Submitted That Met QC Criteria

February 19, 2026

First Posted (Actual)

February 25, 2026

Study Record Updates

Last Update Posted (Actual)

February 25, 2026

Last Update Submitted That Met QC Criteria

February 19, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 091302026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Beginning 6 months after publication of the primary results and available for 5 years thereafter.

IPD Sharing Access Criteria

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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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