Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2025-12-25 @ 8:18 PM
Study NCT ID:
NCT06065969
Status:
UNKNOWN
Last Update Posted:
2023-10-04
First Post:
2023-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Photobiomodulation Dosimetry s in Patients With Orofacial Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005157', 'term': 'Facial Pain'}, {'id': 'D018781', 'term': 'Tension-Type Headache'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D028022', 'term': 'Low-Level Light Therapy'}], 'ancestors': [{'id': 'D053685', 'term': 'Laser Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D010789', 'term': 'Phototherapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-10-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2024-11-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-29', 'studyFirstSubmitDate': '2023-09-12', 'studyFirstSubmitQcDate': '2023-09-29', 'lastUpdatePostDateStruct': {'date': '2023-10-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Headache and orofacial pain', 'timeFrame': 'two weeks', 'description': 'Headache and orofacial pain assessed using the Visual Analog Scale from zero to 10.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['orofacial pain', 'Tension-Type Headache', 'photobiomodulation'], 'conditions': ['Orofacial Pain', 'Tension-Type Headache']}, 'referencesModule': {'references': [{'pmid': '39405292', 'type': 'DERIVED', 'citation': 'Schuler SSV, Campos MCV, Lacerda AJ, Mazzoni AC, Silva T, Silva FCD, Martins MD, Fernandes KPS, Fonseca ES, Mesquita-Ferrari RA, Horliana ACRT, Bussadori SK, Motta LJ. Dosimetry model for photobiomodulation based on anthropometric and hemodynamic variables in patients with orofacial pain post-Covid-19: Study protocol for randomized clinical trial. PLoS One. 2024 Oct 15;19(10):e0309073. doi: 10.1371/journal.pone.0309073. eCollection 2024.'}]}, 'descriptionModule': {'briefSummary': 'This project aims to validate a dosimetry model for photobiomodulation treatment in patients with orofacial pain and tension-type headache symptoms. The study will involve 240 participants divided into four age groups. Different treatment approaches will be applied, including local photobiomodulation and systemic laser therapy. Various physiological measurements will be taken before, during, and after the treatments, including skin type, weight, height, blood pressure, and heart rate. Additionally, data from questionnaires on pain and headache symptoms will be analyzed. Monte Carlo simulation will be employed to validate the model based on these measurements and light transmission. The research addresses the need for effective pain management strategies in cases where medication-based treatments may have unwanted side effects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '7 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria Individuals of both sexes, between 7 and 65 years of age Exclusion Criteria\n\nParticipants with the following characteristics will be excluded:\n\nPregnant individuals Individuals with arrhythmia Individuals with Thrombocytopenia Individuals with Sickle Cell Anemia Individuals with a pacemaker Individuals with alterations in coagulation factors'}, 'identificationModule': {'nctId': 'NCT06065969', 'briefTitle': 'Photobiomodulation Dosimetry s in Patients With Orofacial Pain', 'organization': {'class': 'OTHER', 'fullName': 'University of Nove de Julho'}, 'officialTitle': 'Photobiomodulation Dosimetry Based on Anthropometric and Hemodynamic Variables in Patients With Orofacial Pain', 'orgStudyIdInfo': {'id': 'PBM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Local photobiomodulation', 'description': 'Delivering an energy of 6J per point (60 seconds) at 2 points in the masseter muscle region, 1 point in the temporal muscle, and 1 point in the trapezius muscle in the cervical region. The total application will take 4 minutes per session', 'interventionNames': ['Radiation: Photobiomodulation']}, {'type': 'EXPERIMENTAL', 'label': 'Vascular photobiomodulation', 'description': '660 nm and 100 mW, directing the light beam towards the radial artery region, for 10 minutes per session. The participant will be seated in a comfortable chair with side support for resting their arms during the application', 'interventionNames': ['Radiation: Photobiomodulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'sham local photobiomodulation', 'description': 'The same procedures described for local photobiomodulation will be followed; however, the equipment will emit only the sound signal, exactly like the equipment used in local photobiomodulation group, without emitting laser light.', 'interventionNames': ['Radiation: Photobiomodulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham Vascular photobiomodulation', 'description': 'The same procedures described for vascular photobiomodulation will be followed; however, the equipment will emit only the sound signal, exactly like the equipment used in vascular photobiomodulation group, without emitting laser light', 'interventionNames': ['Radiation: Photobiomodulation']}], 'interventions': [{'name': 'Photobiomodulation', 'type': 'RADIATION', 'description': '660 nm and 100 mW, directing the light beam towards the radial artery region, for 10 minutes per session.', 'armGroupLabels': ['Local photobiomodulation', 'Sham Vascular photobiomodulation', 'Vascular photobiomodulation', 'sham local photobiomodulation']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Nove de Julho', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Researcher', 'investigatorFullName': 'Lara Jansiski Motta', 'investigatorAffiliation': 'University of Nove de Julho'}}}}