Burn Scar PainUS-SCAR-PAINNCT07438769
Ultrasound Predictors of Persistent Burn Scar Pain After Blast and Drone-Related Injuries: A Prospective Cohort Study
An observational study of Burn Scar Pain and Neuropathic Pain, run by Ukrainian Society of Regional Anesthesia and Pain Therapy at 1 site in Ukraine.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Burn Scar Pain, Neuropathic Pain, Combat-Related Burn Injury
- How many people
- 150 participants
- Where
- 1 siteUkraine
- Study dates
- 24 Mar 2026to 23 May 2026
- How long will I take part?
- 6 Months
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study 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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ukraine1 site
Vinnitsya Regional Clinical Hospital n.a Pirogov
Vinnitsya, Select, 21018
Dmytro Dmytriiev, Phd, 0674309449, mddmytriiev@gmail.com
About this study
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.
Read the 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.
- Keywords
- Burn scar pain, ultrasound, nerve entrapment, blast injury, drone injury, neuropathic pain, chronic pain prediction
- Medical subject headings
- Neuralgia, Nerve Compression Syndromes, Blast Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 mounth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start24 Mar 2026 (estimated)
- Primary completion23 May 2026 (estimated)
- Study completion23 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burn Scar PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Ukrainian Society of Regional Anesthesia and Pain Therapy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dmytro Dmytriiev, Ukrainian Society of Regional Anesthesia and Pain Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07438769
- Sponsor's protocol ID
- 23V0123022026
- Other IDs
- USRA
- Acronym
- US-SCAR-PAIN
- Status last verified
- Feb 2026
- First submitted
- 22 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No