Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 5:40 AM
Study NCT ID:
NCT07443358
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-02
First Post:
2026-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Pulsed Electromagnetic Field on Pruritus in Burn Scars
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011537', 'term': 'Pruritus'}], 'ancestors': [{'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'opaque sealed envelope'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'pulsed electromagnetic field and standard care'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-25', 'studyFirstSubmitDate': '2026-02-25', 'studyFirstSubmitQcDate': '2026-02-25', 'lastUpdatePostDateStruct': {'date': '2026-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain intensity', 'timeFrame': 'up to 6 weeks', 'description': 'The Visual Analog Scale (VAS) will be used to measure the intensity of pruritus experienced by participants. The scale consists of a 10 cm horizontal line where 0 cm represents "No itch at all," and 10 cm represents "The worst itch imaginable." Participants will be asked to place a vertical mark on the line corresponding to the severity of their pruritus. The distance from the left end of the scale to the mark, measured in centimeters, will represent the participant\'s itching score, ranging from 0 to 10.'}, {'measure': 'life disability', 'timeFrame': 'up to 6 weeks', 'description': "The ItchyQoL questionnaire will evaluate the impact of pruritus on participants' quality of life across three domains: symptoms, functional limitations, and emotional well-being. It is a 22-item self-administered tool scored on a 5-point Likert scale, with responses ranging from 1 (Not at all) to 5 (Extremely). Higher scores indicate a greater negative impact of itch on quality of life, with total scores ranging from 22 to 110. Subdomain scores will also be calculated to provide a detailed analysis of how itch affects daily activities and emotional well-being.The assessment time for completing the ItchyQoL is typically 5-10 minutes, depending on the patient's literacy level and familiarity with self-reported questionnaires."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['burn scar', 'pruritus', 'pulsed electromagnetic field'], 'conditions': ['Burn Scar']}, 'descriptionModule': {'briefSummary': 'This study will be conducted to evaluate the effectiveness of pulsed electromagnetic field therapy in pruritus in patients with burn scars.', 'detailedDescription': "Burn injuries are among the most devastating and complex forms of trauma, often requiring prolonged medical care and rehabilitation. These injuries can cause substantial damage to the skin and underlying tissues, leading to acute complications such as infection, fluid loss, and metabolic dysregulation. However, the long-term consequences of burn injuries extend beyond the initial trauma, significantly affecting survivors' physical and psychological well-being .The pathophysiology of burn scar pruritus is complex and multifactorial, involving a combination of nerve regeneration, inflammation, and abnormal scar tissue remodeling. During the healing process, damaged nerve fibers regenerate in an unorganized manner, leading to hyperexcitability and an increased sensation of itch. This aberrant nerve regrowth is thought to be a key driver of neuropathic itch in burn scars. Evidence suggests that PEMF therapy may influence nerve signaling pathways involved in neuropathic and inflammatory itch. By addressing both neural and inflammatory components, PEMF therapy offers a novel mechanism of action that could be particularly beneficial for burn survivors. However, its efficacy in the context of burn scar pruritus has not been rigorously evaluated, highlighting the need for clinical research ."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 25-40 years.\n* Patients with second and third-degree burn scars sustained at least 3 months prior to enrollment.\n* Patients experiencing a pruritus score ≥ 5 on the Visual Analog Scale (VAS).\n* Patients who have not undergone prior PEMF therapy or other physical therapy interventions for pruritus in the past 3 months.\n\nExclusion Criteria:\n\n* Patients with cardiac pacemakers, implanted defibrillators, or other electronic medical devices.\n* Pregnant or lactating women.\n* Patients with uncontrolled systemic diseases (e.g., diabetes, hypertension) or active skin infections.\n* Patients with psychological disorders that would interfere with their ability to adhere to the treatment protocol.\n* Patients with allergic reaction to food or drugs'}, 'identificationModule': {'nctId': 'NCT07443358', 'acronym': 'PEM', 'briefTitle': 'Effect of Pulsed Electromagnetic Field on Pruritus in Burn Scars', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effect of Pulsed Electromagnetic Field on Pruritus in Burn Scars', 'orgStudyIdInfo': {'id': 'P.T.REC/012/005747'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'pulsed electromagnetic field therapy', 'description': 'Twenty patients with burn scars will receive pulsed electromagnetic field with standard care three times per weeks for six weeks', 'interventionNames': ['Other: pulsed electromagnetic field therapy', 'Other: standard care']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'standard care', 'description': 'Twenty patients with burn scars will receive standard care three times per weeks for six weeks', 'interventionNames': ['Other: standard care']}], 'interventions': [{'name': 'pulsed electromagnetic field therapy', 'type': 'OTHER', 'description': 'The pulsed electromagnetic field applicator will be positioned 2 cm above the affected burn scar area, ensuring full coverage of the scar with Frequency: 27.12 MHz, Pulse duration: 65 microseconds, and Intensity: 20 Gauss. the patients will receive also standard care', 'armGroupLabels': ['pulsed electromagnetic field therapy']}, {'name': 'standard care', 'type': 'OTHER', 'description': 'the patients will receive standard care in the form of Application of topical emollients (e.g., silicone-based creams) twice daily to maintain hydration, Moisturizing skin care routines to prevent dryness and irritation, and Gentle scar massage for 10 minutes daily to improve scar pliability.', 'armGroupLabels': ['pulsed electromagnetic field therapy', 'standard care']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Asmaa Eliwa, master', 'role': 'CONTACT', 'email': 'dr.asmaa1812@gmail.com', 'phone': '01150761961'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principle investigator : Asmaa ibrahim eliwa', 'investigatorFullName': 'Asmaa Ibrahim Eliwa Sapa', 'investigatorAffiliation': 'Cairo University'}}}}