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

Sponsor

Western University of Health Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT01529151

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Vertigo Dizziness Benign Paroxysmal Positional Vertigo Labyrinthitis	Other: Osteopathic Manipulative Treatment (OMT) Other: Vestibular Rehabilitation Therapy (VRT)	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

26 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Single (Care Provider)

Primary Purpose:

Treatment

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

Study Start Date :

Jan 1, 2012

Actual Primary Completion Date :

Aug 1, 2014

Actual Study Completion Date :

Aug 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: OMT Group 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) 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. Other Names: Osteopathic Manipulative Medicine (OMM)
Active Comparator: VRT Group 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) 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.
Active Comparator: OMT - VRT Group Participants will receive both Osteopathic Manipulative Treatment (OMT) and Vestibular Rehabilitation Therapy (VRT).	Other: Osteopathic Manipulative Treatment (OMT) 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. Other Names: Osteopathic Manipulative Medicine (OMM) Other: Vestibular Rehabilitation Therapy (VRT) 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.
No Intervention: Control Group

Outcome Measures

Primary Outcome Measures

Change from Baseline in Dizziness Handicap Inventory (DHI) at 1 week [Baseline to 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.
Change from Baseline in Dizziness Handicap Inventory (DHI) at 3 weeks [Baseline to 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.
Change from Baseline in Dizziness Handicap Inventory (DHI) at 12 weeks [Baseline to 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.
Change from Baseline in Computerized Dynamic Posturography (CDP) at 1 week [Baseline to 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).
Change from Baseline in Computerized Dynamic Posturography (CDP) at 3 weeks [Baseline to 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).
Change from Baseline in Computerized Dynamic Posturography (CDP) at 12 weeks [Baseline to 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).

Secondary Outcome Measures

Change from Baseline in Neuro-Optometric Evaluation at 1 week [Baseline to 1 week]
Evaluation of visual acuity and refractive status, oculomotor function and visual field status.
Change from Baseline in Neuro-Optometric Evaluation at 3 weeks [Baseline to 3 weeks]
Evaluation of visual acuity and refractive status, oculomotor function and visual field status.
Change from Baseline in Neuro-Optometric Evaluation at 12 weeks. [Baseline to 12 weeks]
Evaluation of visual acuity and refractive status, oculomotor function and visual field status.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 79 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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