Ultrasound Predictors of Persistent Burn Scar Pain After Blast and Drone-Related Injuries: A Prospective Cohort Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Burn Scar Pain, Neuropathic Pain, Combat-Related Burn Injury, Scar-Related Pain. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Ukraine
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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.
Primary outcome measures
- Persistent clinically significant scar pain [Time frame: 3 mounth]
Secondary outcome measures (1)
- Persistent Clinically Significant Scar Pain at 6 Months [Time frame: 6 mounth]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Ukraine · 1 center
- Vinnitsya Regional Clinical Hospital n.a Pirogov — Vinnitsya
Identifiers
NCT: NCT07438769 · 23V0123022026 · USRA