Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07438769

Ultrasound Predictors of Persistent Burn Scar Pain After Blast and Drone-Related Injuries: A Prospective Cohort Study

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Vinnitsya Regional Clinical Hospital n.a Pirogov

Vinnitsya, Select, 21018, Ukraine

Location contact

Dmytro Dmytriiev, Phd

CONTACT

[email protected]

0674309449

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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)

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dmytro Dmytriiev, PhD.Professor

CONTACT

[email protected]

+380674309449

Sponsors and collaborators

Lead sponsor

Ukrainian Society of Regional Anesthesia and Pain Therapy

Other

Registry information

Acronym: US-SCAR-PAIN

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 27, 2026
Registry last updated
Feb 27, 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.

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