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

NCT07438769 — Not yet recruiting, 150 participants, Ukrainian Society of Regional Anesthesia and Pain Therapy

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Registry	NCT07438769, acronym US-SCAR-PAIN
Status	Not yet recruiting
Study type	Observational
Enrollment	150 (Estimated)
Sponsor	Ukrainian Society of Regional Anesthesia and Pain Therapy (Other)
Conditions	Burn Scar Pain, Neuropathic Pain, Combat-Related Burn Injury, Scar-Related Pain
Dates	start 2026-03-24 (estimated), primary completion 2026-05-23 (estimated), completion 2026-05-23 (estimated), first posted 2026-02-27, last updated 2026-02-27
Locations	1 site in Ukraine

-Summary

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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
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.

+Outcome measures

Primary outcomes

Persistent clinically significant scar pain [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

Persistent Clinically Significant Scar Pain at 6 Months [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.

+Eligibility

Sex: All, ages: 18 Years to 60 Years

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)

+Locations (1)

Facility	City	Country	Status
Vinnitsya Regional Clinical Hospital n.a Pirogov	Vinnitsya, Select	Ukraine