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

NCT07432685 | Enrolling By Invitation

• 1 other identifier: 091302026
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Residual Limb Pain; Post-Traumatic Limb Pain; Extremity Trauma; Combat-Related Limb Injury; Phantom Limb Pain; Phantom Limb Pain After Amputation; Chronic Pain Due to Injury; Chronic Pain

Keywords

Chronic Pain; Residual pain; Extremity trauma;; combat injury; limb injury; amputation; mechanical pain threshold

Outcome Measures

Primary Outcomes (1)

• 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).

Secondary Outcomes (3)

• 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

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Charitable Organisation Charitable Fund Superhumans (Co Cf Superhumans): lead

Study Sites (1)

Superhumans War Trauma Center

Lviv, Ukraine

Location

Related Publications (1)

• 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 RESULT

MeSH Terms

Conditions

Phantom Limb; Chronic Pain

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Chief of Science Deparment

Study Record Dates

• First Submitted: February 14, 2026
• First Posted: February 25, 2026
• Study Start: March 12, 2026
• Primary Completion (Estimated): December 22, 2026
• Study Completion (Estimated): December 14, 2027
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Beginning 6 months after publication of the primary results and available for 5 years thereafter.
• 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.

Locations

UA (1)