Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-30 @ 8:43 PM
Study NCT ID:
NCT07438769
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-27
First Post:
2026-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound Predictors of Persistent Burn Scar Pain After Blast and Drone-Related Injuries: A Prospective Cohort Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009437', 'term': 'Neuralgia'}, {'id': 'D009408', 'term': 'Nerve Compression Syndromes'}, {'id': 'D001753', 'term': 'Blast Injuries'}], 'ancestors': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001469', 'term': 'Barotrauma'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-24', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-05-23', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-22', 'studyFirstSubmitDate': '2026-02-22', 'studyFirstSubmitQcDate': '2026-02-22', 'lastUpdatePostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Persistent clinically significant scar pain', 'timeFrame': '3 mounth', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Persistent Clinically Significant Scar Pain at 6 Months', 'timeFrame': '6 mounth', 'description': 'Presence of clinically significant scar pain defined as Numeric Rating Scale (NRS) ≥4 during movement or on light touch at 6 months after enrollment.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Burn scar pain', 'ultrasound', 'nerve entrapment', 'blast injury', 'drone injury', 'neuropathic pain', 'chronic pain prediction'], 'conditions': ['Burn Scar Pain', 'Neuropathic Pain', 'Combat-Related Burn Injury', 'Scar-Related Pain']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://doi.org/10.3389/fphys.2025.1627798', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years\n* Burn injury with clinically formed scar\n* Enrollment 2-12 weeks after injury\n* Scar located on extremities, chest wall, or neck\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* Severe cognitive impairment preventing valid questionnaires\n* Hemodynamic instability or inability to complete baseline evaluation\n* Active systemic infection (enrollment deferred until stable)\n* Pre-existing chronic pain condition unrelated to burn scar that would confound outcomes (investigator judgment)'}, 'identificationModule': {'nctId': 'NCT07438769', 'acronym': 'US-SCAR-PAIN', 'briefTitle': 'Ultrasound Predictors of Persistent Burn Scar Pain After Blast and Drone-Related Injuries: A Prospective Cohort Study', 'organization': {'class': 'OTHER', 'fullName': 'Ukrainian Society of Regional Anesthesia and Pain Therapy'}, 'officialTitle': 'Ultrasound Predictors of Persistent Burn Scar Pain After Blast and Drone-Related Injuries: A Prospective Cohort Study', 'orgStudyIdInfo': {'id': '23V0123022026'}, 'secondaryIdInfos': [{'id': 'USRA', 'type': 'OTHER', 'domain': 'Ukranian Society of Regional Anesthesia and Pain Therapy'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Persistent Scar Pain', 'description': '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.'}, {'label': 'No Persistent Scar Pain', 'description': 'Participants without clinically significant persistent scar pain (NRS \\<4 during movement and light touch) at 3 and 6 months follow-up.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '21018', 'city': 'Vinnitsya', 'state': 'Select', 'country': 'Ukraine', 'contacts': [{'name': 'Dmytro Dmytriiev, Phd', 'role': 'CONTACT', 'email': 'mddmytriiev@gmail.com', 'phone': '0674309449'}], 'facility': 'Vinnitsya Regional Clinical Hospital n.a Pirogov'}], 'centralContacts': [{'name': 'Dmytro Dmytriiev, PhD.Professor', 'role': 'CONTACT', 'email': 'mddmytriiev@gmail.com', 'phone': '+380674309449'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ukrainian Society of Regional Anesthesia and Pain Therapy', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Dmytro Dmytriiev', 'investigatorAffiliation': 'Ukrainian Society of Regional Anesthesia and Pain Therapy'}}}}