Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2025-12-27 @ 11:58 PM
Study NCT ID:
NCT04684693
Status:
UNKNOWN
Last Update Posted:
2021-01-05
First Post:
2020-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Laser Puncture on Rheumatoid Arthritis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007834', 'term': 'Lasers'}], 'ancestors': [{'id': 'D055096', 'term': 'Optical Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D055618', 'term': 'Radiation Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-12-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2021-01-22', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-12-31', 'studyFirstSubmitDate': '2020-12-16', 'studyFirstSubmitQcDate': '2020-12-23', 'lastUpdatePostDateStruct': {'date': '2021-01-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HAQ (Change)', 'timeFrame': 'Pre-intervention, 4 weeks', 'description': 'Health Assessment questionnaire'}, {'measure': 'RAQoL (Change)', 'timeFrame': 'Pre-intervention, 4 weeks', 'description': 'Rheumatoid Arthritis Quality of Life'}, {'measure': 'CRP (Change)', 'timeFrame': 'Pre-intervention, 4 weeks', 'description': 'Analysis of serum C-reactive protein'}, {'measure': 'IL-6 (Change)', 'timeFrame': 'Pre-intervention, 4 weeks', 'description': 'Plasma interleukin-6 inflammatory markers'}, {'measure': 'ATP (Change)', 'timeFrame': 'Pre-intervention, 4 weeks', 'description': 'Plasma ATP concentration anti-oxidant marker'}, {'measure': 'MDA (Change)', 'timeFrame': 'Pre-intervention, 4 weeks', 'description': 'plasma malondialdehyde oxidative marker'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'references': [{'pmid': '33966520', 'type': 'DERIVED', 'citation': 'Adly AS, Adly AS, Adly MS, Ali MF. A novel approach utilizing laser acupuncture teletherapy for management of elderly-onset rheumatoid arthritis: A randomized clinical trial. J Telemed Telecare. 2021 Jun;27(5):298-306. doi: 10.1177/1357633X211009861. Epub 2021 May 9.'}]}, 'descriptionModule': {'briefSummary': 'Studying the effect of laser puncture on rheumatoid arthritis patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Meeting the criteria of ACR classification for rheumatoid arthritis\n* Meeting the criteria of EULAR classification for rheumatoid arthritis\n\nExclusion Criteria:\n\n* Having malignancy\n* Having connective tissue disease\n* Smokers'}, 'identificationModule': {'nctId': 'NCT04684693', 'briefTitle': 'Effect of Laser Puncture on Rheumatoid Arthritis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effect of Laser Puncture on Rheumatoid Arthritis Patients', 'orgStudyIdInfo': {'id': 'REC/010-2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Laser Group', 'interventionNames': ['Device: Laser']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'interventionNames': ['Procedure: Control']}], 'interventions': [{'name': 'Laser', 'type': 'DEVICE', 'description': 'Laser puncture and exercise', 'armGroupLabels': ['Laser Group']}, {'name': 'Control', 'type': 'PROCEDURE', 'description': 'Exercise', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'M. Sedky', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'A. Sedky', 'investigatorAffiliation': 'Cairo University'}}}}