Ultrasound Predictors of Persistent Burn Scar Pain After Blast and Drone-Related Injuries: A Prospective Cohort Study (US-SCAR-PAIN)

February 22, 2026 updated by: Dmytro Dmytriiev, Ukrainian Society of Regional Anesthesia and Pain Therapy
Persistent burn scar pain is common after blast and drone-related injuries and may be driven by scar fibrosis, vascular activity, and peripheral nerve involvement within scar tissue. This prospective cohort study aims to determine whether early ultrasound features of scars and nerves predict persistent clinically significant scar pain at 3 and 6 months. Ultrasound measures include scar thickness, echogenicity, Power Doppler vascularity, dynamic adhesion (gliding) assessment, and ultrasound signs of nerve involvement ("US-nerve positive"). Clinical outcomes include pain intensity (NRS), neuropathic pain screening (DN4), and functional interference.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Participants with burn scars 2-12 weeks after injury will undergo standardized baseline assessment including pain ratings at rest, during movement, and on light touch, DN4 screening, basic scar assessment, and a structured ultrasound examination using a high-frequency linear probe (10-18 MHz). Ultrasound endpoints include scar thickness, echogenicity pattern, Power Doppler vascularity grade, dynamic adhesion score, and nerve involvement defined as presence of ≥2 out of 5 ultrasound criteria (focal nerve thickening, hypoechoic fascicular distortion, nerve traversing scar tissue, reduced gliding, and sonopalpation pain reproduction). Follow-up assessments will be performed at 6 weeks, 3 months, and 6 months. The primary analysis will evaluate the association between baseline ultrasound features and persistent clinically significant scar pain (NRS ≥4 during movement or touch) at 3 or 6 months.

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

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

Study Contact

Study Locations

  • Ukraine
    • Select
      • Vinnitsya, Select, Ukraine, 21018
        • Vinnitsya Regional Clinical Hospital n.a Pirogov
        • Contact:

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

The study population will consist of adult patients (≥18 years) with clinically formed burn scars following blast-related, drone-related, or comparable burn injuries. Participants will be enrolled between 2 and 12 weeks after injury and followed prospectively for 6 months. Scars may be located on extremities, chest wall, or neck. The study population represents individuals at risk of developing persistent scar pain after combat-related or high-energy burn trauma.

Description

Inclusion Criteria:

  • Age ≥18 years
  • Burn injury with clinically formed scar
  • Enrollment 2-12 weeks after injury
  • Scar located on extremities, chest wall, or neck
  • Ability to provide written informed consent

Exclusion Criteria:

  • Severe cognitive impairment preventing valid questionnaires
  • Hemodynamic instability or inability to complete baseline evaluation
  • Active systemic infection (enrollment deferred until stable)
  • Pre-existing chronic pain condition unrelated to burn scar that would confound outcomes (investigator judgment)

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

Cohorts and Interventions

Group / Cohort
Persistent Scar Pain
articipants who develop clinically significant persistent scar pain defined as NRS ≥4 during movement or light touch at 3 or 6 months follow-up after burn injury.
No Persistent Scar Pain
Participants without clinically significant persistent scar pain (NRS <4 during movement and light touch) at 3 and 6 months follow-up.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Persistent clinically significant scar pain
Time Frame: 3 mounth
Persistent scar pain defined as Numeric Rating Scale (NRS) ≥4 during movement or on light touch at follow-up assessment. The primary endpoint is the presence of clinically significant pain at 3 months after enrollment.
3 mounth

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Persistent Clinically Significant Scar Pain at 6 Months
Time Frame: 6 mounth
Presence of clinically significant scar pain defined as Numeric Rating Scale (NRS) ≥4 during movement or on light touch at 6 months after enrollment.
6 mounth

Collaborators and Investigators

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

Sponsor

Ukrainian Society of Regional Anesthesia and Pain Therapy

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.

Helpful Links

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 24, 2026

Primary Completion (Estimated)

May 23, 2026

Study Completion (Estimated)

May 23, 2026

Study Registration Dates

First Submitted

February 22, 2026

First Submitted That Met QC Criteria

February 22, 2026

First Posted (Actual)

February 27, 2026

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 22, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23V0123022026
  • USRA (Other Identifier: Ukranian Society of Regional Anesthesia and Pain Therapy)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

Clinical Trials on Neuropathic Pain

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Africa

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe