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| ID | Type | Description | Link |
|---|---|---|---|
| 11-13-647 | Other Grant/Funding Number | American Osteopathic Association Council on Research and Osteopathic Heritage Foundation |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OMT Group | Active Comparator | 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. |
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| VRT Group | Active Comparator | Participants will receive Vestibular Rehabilitation Therapy (VRT), which includes balance exercises in sitting and standing positions that include gaze stabilization, kinesthetic and proprioceptive retraining. |
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| OMT - VRT Group | Active Comparator | Participants will receive both Osteopathic Manipulative Treatment (OMT) and Vestibular Rehabilitation Therapy (VRT). |
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| Control Group | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Osteopathic Manipulative Treatment (OMT) | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Dizziness Handicap Inventory (DHI) at 1 week | 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. | Baseline to 1 week |
| Change from Baseline in Dizziness Handicap Inventory (DHI) at 3 weeks | 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. | Baseline to 3 weeks |
| Change from Baseline in Dizziness Handicap Inventory (DHI) at 12 weeks | 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. | Baseline to 12 weeks |
| Change from Baseline in Computerized Dynamic Posturography (CDP) at 1 week | 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). | Baseline to 1 week |
| Change from Baseline in Computerized Dynamic Posturography (CDP) at 3 weeks | 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 | Description | Time Frame |
|---|---|---|
| Change from Baseline in Neuro-Optometric Evaluation at 1 week | Evaluation of visual acuity and refractive status, oculomotor function and visual field status. | Baseline to 1 week |
| Change from Baseline in Neuro-Optometric Evaluation at 3 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marcel Fraix, DO | Western University of Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Western University Physical Therapy Research Laboratory | Pomona | California | 91766 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20659716 | Background | 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. | |
| 33125033 | Derived | 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. |
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| Vestibular Rehabilitation Therapy (VRT) | Other | 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. |
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| Baseline to 3 weeks |
| Change from Baseline in Computerized Dynamic Posturography (CDP) at 12 weeks | 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). | Baseline to 12 weeks |
Evaluation of visual acuity and refractive status, oculomotor function and visual field status.
| Baseline to 3 weeks |
| Change from Baseline in Neuro-Optometric Evaluation at 12 weeks. | Evaluation of visual acuity and refractive status, oculomotor function and visual field status. | Baseline to 12 weeks |
| ID | Term |
|---|---|
| D014717 | Vertigo |
| D004244 | Dizziness |
| D065635 | Benign Paroxysmal Positional Vertigo |
| D007762 | Labyrinthitis |
| ID | Term |
|---|---|
| D015837 | Vestibular Diseases |
| D007759 | Labyrinth Diseases |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012678 | Sensation Disorders |
| D010031 | Otitis |
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| ID | Term |
|---|---|
| D026301 | Manipulation, Osteopathic |
| ID | Term |
|---|---|
| D026201 | Musculoskeletal Manipulations |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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