Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2026-01-04 @ 2:19 PM
Study NCT ID:
NCT05504369
Status:
COMPLETED
Last Update Posted:
2022-08-17
First Post:
2022-08-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Magnetic Tape on the Autonomic Nervous System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}], 'ancestors': [{'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Participant and researchers where not aware of the magnetic tape versus placebo tape as the look and feel identical'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single group design with random allocation of intervention placebo versus treatment tape. Next day other intervention was used'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-16', 'studyFirstSubmitDate': '2022-08-10', 'studyFirstSubmitQcDate': '2022-08-16', 'lastUpdatePostDateStruct': {'date': '2022-08-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pupillometry', 'timeFrame': '60 seconds measure preceding tape application. After outcome 5', 'description': '1 minute continues pupil diameter measure'}, {'measure': 'Pupillometry', 'timeFrame': 'Second 60 second measure immediate after tape application. After outcome 1', 'description': '1 minute continues pupil diameter measure'}, {'measure': 'Pupillometry', 'timeFrame': 'Third 60 measure 3 minutes after the tape is removed. After outcome 2', 'description': '1 minute continues pupil diameter measure'}], 'secondaryOutcomes': [{'measure': 'PA spine', 'timeFrame': 'First PA measure of 5 seconds on each PA of 5 seconds on each segment is starting off the measurement phase. This is the first outcome measure', 'description': 'Anterior (PA) pressure on each spinal segment'}, {'measure': 'Skin pinch test', 'timeFrame': '3 seconds skin pinch test at each level starting immediately following the first PA measure. After Outcome 4', 'description': 'Bilaterally of each vertebrae'}, {'measure': 'PA spine', 'timeFrame': 'Five second measure of PA of 5 seconds each segment is taken immediately after the third pupillometry measure (tape removed). After outcome 3', 'description': 'Anterior (PA) pressure on each spinal segment'}, {'measure': 'Skin Pinch test', 'timeFrame': '3 seconds skin pinch test at each level starting immediately following outcome 6', 'description': 'Bilaterally of each vertebrae'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Magnetic tape', 'magnetic nano particles', 'Pupillometry', 'Autonomic nervous system', 'lower back pain', 'PA test', 'Skin pinch test'], 'conditions': ['Low Back Pain']}, 'descriptionModule': {'briefSummary': 'The effect of magnetic tape on pain and autonomic nervous system in subject with lower back pain.', 'detailedDescription': 'The effects of magnetic nanoparticles in tape applied in the lumbar spine on the autonomic nervous system measured with fully automated pupillometry and on pain in the spine measured with posterior to anterior pressure on the spinous process and the skin pinch test paravertebrally'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Current lower back pain with NPRS of 5\n* Between ages 18-65\n\nExclusion Criteria:\n\n* No lower back pain or pain \\<5 on the NPRS\n* Not meeting age limit\n* Having condition that prevents the PA procedure\n* Conditions of the nervous system and inability keep eyes open'}, 'identificationModule': {'nctId': 'NCT05504369', 'briefTitle': 'Effects of Magnetic Tape on the Autonomic Nervous System', 'organization': {'class': 'OTHER', 'fullName': 'Florida Gulf Coast University'}, 'officialTitle': 'Effects of Magnetic Tape on the Autonomic Nervous System', 'orgStudyIdInfo': {'id': '1240878'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Magnetic tape arm', 'description': 'Tape application bilaterally in the lumbar spine', 'interventionNames': ['Other: Magnetic tape']}, {'type': 'SHAM_COMPARATOR', 'label': 'Placebo tape arm', 'description': 'Tape application bilaterally in the lumbar spine', 'interventionNames': ['Other: Placebo tape']}], 'interventions': [{'name': 'Magnetic tape', 'type': 'OTHER', 'description': 'Tape with magnetic nanoparticles applied to the skin', 'armGroupLabels': ['Magnetic tape arm']}, {'name': 'Placebo tape', 'type': 'OTHER', 'description': 'Tape without nano particles applied to the skin', 'armGroupLabels': ['Placebo tape arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46010', 'city': 'Valencia de Alcántara', 'country': 'Spain', 'facility': 'University of Valencia', 'geoPoint': {'lat': 39.41148, 'lon': -7.24435}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No plan in place'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Florida Gulf Coast University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Valencia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Dr. Rob Sillevis,', 'investigatorAffiliation': 'Florida Gulf Coast University'}}}}