Vinnitsya Regional Clinical Hospital n.a Pirogov
Vinnitsya, Select, 21018, Ukraine
NCT Number: NCT07438769
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.
Trial opening soon.
Get Notified18 year–60 year
All sexes
Observational
Vinnitsya, Select, 21018, Ukraine
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Contact information is provided by the study sponsor or research team.
Ukrainian Society of Regional Anesthesia and Pain Therapy
Other
Acronym: US-SCAR-PAIN
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