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

June 8, 2015 updated by: Western University of Health Sciences

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Pomona, California, United States, 91766
        • Western University Physical Therapy Research Laboratory

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 79 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Control Group
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.

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Neuro-Optometric Evaluation at 1 week
Time Frame: Baseline to 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
Time Frame: Baseline to 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.
Time Frame: Baseline to 12 weeks
Evaluation of visual acuity and refractive status, oculomotor function and visual field status.
Baseline to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Western University of Health Sciences

Investigators

  • Principal Investigator: Marcel Fraix, DO, Western University of Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (ACTUAL)

August 1, 2014

Study Completion (ACTUAL)

August 1, 2014

Study Registration Dates

First Submitted

January 31, 2012

First Submitted That Met QC Criteria

February 3, 2012

First Posted (ESTIMATE)

February 8, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

June 10, 2015

Last Update Submitted That Met QC Criteria

June 8, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11/IRB/033
  • 11-13-647 (OTHER_GRANT: American Osteopathic Association Council on Research and Osteopathic Heritage Foundation)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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