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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-60
SponsorUkrainian Society of Regional Anesthesia and Pain Therapy

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years

Burn injury with clinically formed scar

Enrollment 2-12 weeks after injury

Scar located on extremities, chest wall, or neck

Disqualifiers

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)

Trial population

The study population will consist of adult patients (≥18 years) with clinically formed burn scars following blast-related, drone-related, or comparable burn injuries. Participants will be enrolled between 2 and 12 weeks after injury and followed prospectively for 6 months. Scars may be located on extremities, chest wall, or neck. The study population represents individuals at risk of developing persistent scar pain after combat-related or high-energy burn trauma.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

150 Participants
are grouped into 2 trial groups
Group A: Persistent Scar Pain
Group B: No Persistent Scar Pain

Trial outcomes

Primary outcomes

1

Persistent clinically significant scar pain

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
3 mounth

Secondary outcomes

1

Persistent Clinically Significant Scar Pain at 6 Months

Presence of clinically significant scar pain defined as Numeric Rating Scale (NRS) ≥4 during movement or on light touch at 6 months after enrollment.

Time frame
6 mounth

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Vinnitsya Regional Clinical Hospital n.a Pirogov Status unavailable 21018, Vinnitsya, SelectUkraineUkraine

Sponsors and contacts

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