Effectiveness of Osteopathic Manipulative Treatment (OMT) and Vestibular Rehabilitation Therapy (VRT) in Individuals With Vertigo

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
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

Conditions
-----------------
Vertigo, Dizziness, Benign Paroxysmal Positional Vertigo, Labyrinthitis

Intervention / Treatment
-----------------
* Other: Osteopathic Manipulative Treatment (OMT)
* Other: Vestibular Rehabilitation Therapy (VRT)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Symptoms of dizziness or a diagnosis of vertigo for longer than 3 months duration Able to tolerate 30 minutes of sitting and standing Able to transfer from sitting to standing and move independently Able tolerate manual therapy and exercise Exclusion Criteria: Severe traumatic injury Bleeding disorders and anticoagulation (Coumadin) therapy Currently receiving VRT, vision therapy, or manual medicine (OMT, Chiropractic, etc.) or received manual medicine within the past three months Down syndrome Ehlers-Danlos syndrome Endolymphatic Hydrops Legal blindness in one or both eyes Menieres disease Neurological conditions (including Peripheral Neuropathy, Stroke, traumatic brain injury, cerebral aneurysm, and Multiple Sclerosis) Rheumatoid Arthritis Spinal trauma or history of cervical spine surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: OMT Group<br>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. | Other: Osteopathic Manipulative Treatment (OMT)<br>* 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.<br>* Other names: Osteopathic Manipulative Medicine (OMM);|
| Active Comparator: VRT Group<br>Participants will receive Vestibular Rehabilitation Therapy (VRT), which includes balance exercises in sitting and standing positions that include gaze stabilization, kinesthetic and proprioceptive retraining. | Other: Vestibular Rehabilitation Therapy (VRT)<br>* 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.<br>|
| Active Comparator: OMT - VRT Group<br>Participants will receive both Osteopathic Manipulative Treatment (OMT) and Vestibular Rehabilitation Therapy (VRT). | Other: Osteopathic Manipulative Treatment (OMT)<br>* 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.<br>* Other names: Osteopathic Manipulative Medicine (OMM);Other: Vestibular Rehabilitation Therapy (VRT)<br>* 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.<br>|
| No Intervention: Control Group<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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). | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dizziness, Vertigo, Benign Paroxysmal Positional Vertigo, Labyrinthitis, Osteopathic Manipulative Treatment, Vestibular Rehabilitation Therapy