Ignite Creation Date:
2025-12-24 @ 3:04 PM
Ignite Modification Date:
2025-12-26 @ 1:44 PM
Study NCT ID:
NCT05118659
Status:
COMPLETED
Last Update Posted:
2021-11-12
First Post:
2021-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mulligan Therapy Effects In Healthy Subjects With Induced Vertigo
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014717', 'term': 'Vertigo'}], 'ancestors': [{'id': 'D015837', 'term': 'Vestibular Diseases'}, {'id': 'D007759', 'term': 'Labyrinth Diseases'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'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': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2018-06-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-03', 'studyFirstSubmitDate': '2021-10-19', 'studyFirstSubmitQcDate': '2021-11-03', 'lastUpdatePostDateStruct': {'date': '2021-11-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'vHIT (Video Head Impulse Test)', 'timeFrame': '15 minutes', 'description': 'Detection of peripheral vestibular deficits and their recovery'}], 'secondaryOutcomes': [{'measure': 'Anxiety', 'timeFrame': '5 minutes', 'description': 'state-trait anxiety was measured at the beginning of the study using the Spanish version of the trait-state anxiety inventory (STAI)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Vertigo']}, 'descriptionModule': {'briefSummary': 'This analysis aims to evaluate the immediate effect that cervical sustained natural apophyseal glides (SNAGs) have on a group of individuals with induced vertigo by a caloric vestibular stimulation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '44 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy subjects,\n* Age 18-44 years.\n\nExclusion Criteria:\n\n* Consume of antipsychotics, antidepressants, antiarrythmics and/or anticonvulsivants\n* Hippoacusia\n* Auditory diseases\n* Peripheral or central vestibulopathies\n* Cerviogenic dizziness\n* Balance disorders\n* Nistagmus\n* Oculomotor nerve dysfunctions\n* Migraine\n* Cervical osteoporosis, lashing or fracture\n* Discal cervical hernia\n* Cervical neuropathy\n* Psychriatic disorders\n* Epilepsy\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT05118659', 'briefTitle': 'Mulligan Therapy Effects In Healthy Subjects With Induced Vertigo', 'organization': {'class': 'OTHER', 'fullName': 'Centro Universitario La Salle'}, 'officialTitle': 'Mulligan Therapy Effects In Healthy Subjects With Induced Vertigo. A Randomized And Controlled Clinic Study', 'orgStudyIdInfo': {'id': 'CSEULS-PI-198/2018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SNAG GROUP', 'description': 'The SNAG group received a treatment based on sustained apophyseal glides in a postero-anterior direction on C2 with a dose of three series of ten repetitions each, combined with active cervical extension.', 'interventionNames': ['Procedure: sustained natural apophyseal glides']}, {'type': 'SHAM_COMPARATOR', 'label': 'SHAM SNAG GROUP', 'description': 'The placebo SNAG group received a simulation of the contact used for the SNAGs, without any vertebral glide, and with an active cervical extension.', 'interventionNames': ['Procedure: SHAM SNAG']}, {'type': 'NO_INTERVENTION', 'label': 'CONTROL GROUP', 'description': 'The control group did not receive any type of intervention, they only waited for four minutes, sat down on a chair'}], 'interventions': [{'name': 'sustained natural apophyseal glides', 'type': 'PROCEDURE', 'otherNames': ['SNAG'], 'description': 'It consists on a sustained apophyseal glides in a postero-anterior direction on C2 with a dose of three series of ten repetitions each', 'armGroupLabels': ['SNAG GROUP']}, {'name': 'SHAM SNAG', 'type': 'PROCEDURE', 'description': 'Subjects on SNAG group received a simulation of the contact used for the SNAGs, without any vertebral glide, and with an active cervical extension', 'armGroupLabels': ['SHAM SNAG GROUP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28023', 'city': 'Madrid', 'country': 'Spain', 'facility': 'CSEU La Salle', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28023', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Jose V Leon Hernandez', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data will only be treated by study researchers'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centro Universitario La Salle', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jose Vicente Leon Hernandez', 'investigatorAffiliation': 'Centro Universitario La Salle'}}}}