Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2026-02-24 @ 10:56 AM
Study NCT ID:
NCT01529151
Status:
COMPLETED
Last Update Posted:
2015-06-10
First Post:
2012-01-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Osteopathic Manipulative Treatment (OMT) and Vestibular Rehabilitation Therapy (VRT) in Individuals With Vertigo
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014717', 'term': 'Vertigo'}, {'id': 'D004244', 'term': 'Dizziness'}, {'id': 'D065635', 'term': 'Benign Paroxysmal Positional Vertigo'}, {'id': 'D007762', 'term': 'Labyrinthitis'}], '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'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D010031', 'term': 'Otitis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D026301', 'term': 'Manipulation, Osteopathic'}], 'ancestors': [{'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-08', 'studyFirstSubmitDate': '2012-01-31', 'studyFirstSubmitQcDate': '2012-02-03', 'lastUpdatePostDateStruct': {'date': '2015-06-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-02-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline in Dizziness Handicap Inventory (DHI) at 1 week', 'timeFrame': 'Baseline to 1 week', 'description': 'The Dizziness Handicap Inventory (DHI) is a questionnaire that was developed to measure the self-perceived level of handicap associated with the symptom of dizziness.'}, {'measure': 'Change from Baseline in Dizziness Handicap Inventory (DHI) at 3 weeks', 'timeFrame': 'Baseline to 3 weeks', 'description': 'The Dizziness Handicap Inventory (DHI) is a questionnaire that was developed to measure the self-perceived level of handicap associated with the symptom of dizziness.'}, {'measure': 'Change from Baseline in Dizziness Handicap Inventory (DHI) at 12 weeks', 'timeFrame': 'Baseline to 12 weeks', 'description': 'The Dizziness Handicap Inventory (DHI) is a questionnaire that was developed to measure the self-perceived level of handicap associated with the symptom of dizziness.'}, {'measure': 'Change from Baseline in Computerized Dynamic Posturography (CDP) at 1 week', 'timeFrame': 'Baseline to 1 week', 'description': 'Computerized dynamic posturography (CDP), also called test of balance (TOB), is a non-invasive specialized clinical assessment technique used to quantify the central nervous system adaptive mechanisms (sensory, motor and central) involved in the control of posture and balance, both in normal (such as in physical education and sports training) and abnormal conditions (particularly in the diagnosis of balance disorders and in physical therapy and postural re-education).'}, {'measure': 'Change from Baseline in Computerized Dynamic Posturography (CDP) at 3 weeks', 'timeFrame': 'Baseline to 3 weeks', 'description': 'Computerized dynamic posturography (CDP), also called test of balance (TOB), is a non-invasive specialized clinical assessment technique used to quantify the central nervous system adaptive mechanisms (sensory, motor and central) involved in the control of posture and balance, both in normal (such as in physical education and sports training) and abnormal conditions (particularly in the diagnosis of balance disorders and in physical therapy and postural re-education).'}, {'measure': 'Change from Baseline in Computerized Dynamic Posturography (CDP) at 12 weeks', 'timeFrame': 'Baseline to 12 weeks', 'description': 'Computerized dynamic posturography (CDP), also called test of balance (TOB), is a non-invasive specialized clinical assessment technique used to quantify the central nervous system adaptive mechanisms (sensory, motor and central) involved in the control of posture and balance, both in normal (such as in physical education and sports training) and abnormal conditions (particularly in the diagnosis of balance disorders and in physical therapy and postural re-education).'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline in Neuro-Optometric Evaluation at 1 week', 'timeFrame': 'Baseline to 1 week', 'description': 'Evaluation of visual acuity and refractive status, oculomotor function and visual field status.'}, {'measure': 'Change from Baseline in Neuro-Optometric Evaluation at 3 weeks', 'timeFrame': 'Baseline to 3 weeks', 'description': 'Evaluation of visual acuity and refractive status, oculomotor function and visual field status.'}, {'measure': 'Change from Baseline in Neuro-Optometric Evaluation at 12 weeks.', 'timeFrame': 'Baseline to 12 weeks', 'description': 'Evaluation of visual acuity and refractive status, oculomotor function and visual field status.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Dizziness', 'Vertigo', 'Benign Paroxysmal Positional Vertigo', 'Labyrinthitis', 'Osteopathic Manipulative Treatment', 'Vestibular Rehabilitation Therapy'], 'conditions': ['Vertigo', 'Dizziness', 'Benign Paroxysmal Positional Vertigo', 'Labyrinthitis']}, 'referencesModule': {'references': [{'pmid': '20659716', 'type': 'BACKGROUND', 'citation': 'Fraix M. Osteopathic manipulative treatment and vertigo: a pilot study. PM R. 2010 Jul;2(7):612-8. doi: 10.1016/j.pmrj.2010.04.001.'}, {'pmid': '33125033', 'type': 'DERIVED', 'citation': 'Fraix M, Badran S, Graham V, Redman-Bentley D, Hurwitz EL, Quan VL, Yim M, Hudson-McKinney M, Seffinger MA. Osteopathic manipulative treatment in individuals with vertigo and somatic dysfunction: a randomized, controlled, comparative feasibility study. J Osteopath Med. 2021 Jan 1;121(1):71-83. doi: 10.7556/jaoa.2020.147.'}]}, 'descriptionModule': {'briefSummary': 'Western University of Health Sciences is seeking men and women to participate in a study on the effectiveness of Osteopathic Manipulative Treatment (OMT) and Vestibular Rehabilitation Therapy (VRT) in patients with vertigo. The purpose of this study is to examine the efficacy of OMT in the treatment of individuals with vertigo, alone and in combination with Vestibular Rehabilitation Therapy (VRT). Because of the health care costs associated with vertigo, the cost effectiveness of OMT and VRT will also be examined.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Symptoms of dizziness or a diagnosis of vertigo for longer than 3 months duration\n* Able to tolerate 30 minutes of sitting and standing\n* Able to transfer from sitting to standing and move independently\n* Able tolerate manual therapy and exercise\n\nExclusion Criteria:\n\n* Severe traumatic injury\n* Bleeding disorders and anticoagulation (Coumadin) therapy\n* Currently receiving VRT, vision therapy, or manual medicine (OMT, Chiropractic, etc.) or received manual medicine within the past three months\n* Down syndrome\n* Ehlers-Danlos syndrome\n* Endolymphatic Hydrops\n* Legal blindness in one or both eyes\n* Menieres disease\n* Neurological conditions (including Peripheral Neuropathy, Stroke, traumatic brain injury, cerebral aneurysm, and Multiple Sclerosis)\n* Rheumatoid Arthritis\n* Spinal trauma or history of cervical spine surgery'}, 'identificationModule': {'nctId': 'NCT01529151', 'briefTitle': 'Effectiveness of Osteopathic Manipulative Treatment (OMT) and Vestibular Rehabilitation Therapy (VRT) in Individuals With Vertigo', 'organization': {'class': 'OTHER', 'fullName': 'Western University of Health Sciences'}, 'officialTitle': 'Effectiveness of Osteopathic Manipulative Treatment (OMT) and Vestibular Rehabilitation Therapy (VRT) Alone or in Combination on Balance and Visual Function in Individuals With Vertigo and Somatic Dysfunction', 'orgStudyIdInfo': {'id': '11/IRB/033'}, 'secondaryIdInfos': [{'id': '11-13-647', 'type': 'OTHER_GRANT', 'domain': 'American Osteopathic Association Council on Research and Osteopathic Heritage Foundation'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'OMT Group', 'description': 'Participants will receive Osteopathic Manipulative Treatment (OMT) with the objective of treating diagnosed somatic dysfunction and this will entail the use of specific indirect and direct techniques, including soft tissue, inhibitory, myofascial release, articulatory and high-velocity / low-amplitude (HVLA) techniques.', 'interventionNames': ['Other: Osteopathic Manipulative Treatment (OMT)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'VRT Group', 'description': 'Participants will receive Vestibular Rehabilitation Therapy (VRT), which includes balance exercises in sitting and standing positions that include gaze stabilization, kinesthetic and proprioceptive retraining.', 'interventionNames': ['Other: Vestibular Rehabilitation Therapy (VRT)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'OMT - VRT Group', 'description': 'Participants will receive both Osteopathic Manipulative Treatment (OMT) and Vestibular Rehabilitation Therapy (VRT).', 'interventionNames': ['Other: Osteopathic Manipulative Treatment (OMT)', 'Other: Vestibular Rehabilitation Therapy (VRT)']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group'}], 'interventions': [{'name': 'Osteopathic Manipulative Treatment (OMT)', 'type': 'OTHER', 'otherNames': ['Osteopathic Manipulative Medicine (OMM)'], 'description': 'Direct action OMT procedures, including HVLA, involve the application of a force in the direction of restricted joint motion in order to resolve somatic dysfunction. Indirect techniques, including counterstrain, balanced ligamentous tension and myofascial release, entail applying a force away from the restrictive barrier of a joint or soft tissue structure.', 'armGroupLabels': ['OMT - VRT Group', 'OMT Group']}, {'name': 'Vestibular Rehabilitation Therapy (VRT)', 'type': 'OTHER', 'description': 'Participants categorized as having a peripheral motion hypersensitivity will receive habituation exercises that reproduce the provocative motion, seated and standing balance exercises with gaze stabilization, kinesthetic and proprioceptive retraining. Participants will be given a monthly exercise log at onset and will be asked to report exercise levels at subsequent follow up periods.', 'armGroupLabels': ['OMT - VRT Group', 'VRT Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91766', 'city': 'Pomona', 'state': 'California', 'country': 'United States', 'facility': 'Western University Physical Therapy Research Laboratory', 'geoPoint': {'lat': 34.05529, 'lon': -117.75228}}], 'overallOfficials': [{'name': 'Marcel Fraix, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Western University of Health Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Western University of Health Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}