We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu
IMPORTANT: Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01529151
Recruitment Status : Completed
First Posted : February 8, 2012
Last Update Posted : June 10, 2015
Sponsor:
Information provided by (Responsible Party):

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
Vertigo Dizziness Benign Paroxysmal Positional Vertigo Labyrinthitis Other: Osteopathic Manipulative Treatment (OMT) Other: Vestibular Rehabilitation Therapy (VRT)

Study Design

Study Type : Interventional  (Clinical Trial)
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 : January 2012
Primary Completion Date : August 2014
Study Completion Date : August 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 Name: 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 Name: 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 :
  1. 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.

  2. 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.

  3. 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.

  4. 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).

  5. 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).

  6. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01529151


Locations
United States, California
Western University Physical Therapy Research Laboratory
Pomona, California, United States, 91766
Sponsors and Collaborators
Western University of Health Sciences
Investigators
Principal Investigator: Marcel Fraix, DO Western University of Health Sciences
More Information

Publications:
Responsible Party: Western University of Health Sciences
ClinicalTrials.gov Identifier: NCT01529151     History of Changes
Other Study ID Numbers: 11/IRB/033
11-13-647 ( Other Grant/Funding Number: American Osteopathic Association Council on Research and Osteopathic Heritage Foundation )
First Posted: February 8, 2012    Key Record Dates
Last Update Posted: June 10, 2015
Last Verified: June 2015

Keywords provided by Western University of Health Sciences:
Dizziness
Vertigo
Benign Paroxysmal Positional Vertigo
Labyrinthitis
Osteopathic Manipulative Treatment
Vestibular Rehabilitation Therapy

Additional relevant MeSH terms:
Vertigo
Dizziness
Benign Paroxysmal Positional Vertigo
Labyrinthitis
Labyrinth Diseases
Vestibular Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Sensation Disorders
Otitis