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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
26

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Western University of Health Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2012

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2014

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 31, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 3, 2012

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 8, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 10, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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