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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07438769
Acronym
US-SCAR-PAIN
Enrollment
150
Registered
2026-02-27
Start date
2026-03-24
Completion date
2026-05-23
Last updated
2026-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burn Scar Pain, Combat-Related Burn Injury, Neuropathic Pain, Scar-Related Pain

Keywords

Burn scar pain, ultrasound, nerve entrapment, blast injury, drone injury, neuropathic pain, chronic pain prediction

Brief 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.

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.

Interventions

None listed

Sponsors

Ukrainian Society of Regional Anesthesia and Pain Therapy
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Persistent clinically significant scar pain3 mounthPersistent 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

MeasureTime frameDescription
Persistent Clinically Significant Scar Pain at 6 Months6 mounthPresence of clinically significant scar pain defined as Numeric Rating Scale (NRS) ≥4 during movement or on light touch at 6 months after enrollment.

Countries

Ukraine

Contacts

CONTACTDmytro Dmytriiev, PhD.Professor
mddmytriiev@gmail.com+380674309449

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026