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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Predictors of Persistent Burn Scar Pain After Blast and Drone-Related Injuries: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07438769
- Acronym / sponsor ID
- US-SCAR-PAIN / 23V0123022026
- Keywords
- Burn scar pain, ultrasound, nerve entrapment, blast injury, drone injury, neuropathic pain, chronic pain prediction
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Ukrainian Society of Regional Anesthesia and Pain TherapyUniversity, hospital or other
- Study start
- 24 Mar 2026 (estimated)
- Primary completion
- 23 May 2026 (estimated)
- Study completion
- 23 May 2026 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Persistent clinically significant scar pain
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.
1 secondary outcome
Persistent Clinically Significant Scar Pain at 6 Months
Time frame: 6 mounth
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dmytro Dmytriiev, PhD.Professor (+380674309449, mddmytriiev@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Persistent clinically significant scar pain (time frame: 3 mounth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.