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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Western University of Health Sciences.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Western University of Health Sciences
ClinicalTrials.gov Identifier:
NCT01529151
First received: January 31, 2012
Last updated: March 12, 2012
Last verified: March 2012
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Caregiver)
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

Resource links provided by NLM:


Further study details as provided by Western University of Health Sciences:

Primary Outcome Measures:
  • Change from Baseline in Dizziness Handicap Inventory (DHI) at 1 week [ Time Frame: Baseline to 1 week ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to 3 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to 1 week ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to 3 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to 1 week ] [ Designated as safety issue: No ]
    Evaluation of visual acuity and refractive status, oculomotor function and visual field status.

  • Change from Baseline in Neuro-Optometric Evaluation at 3 weeks [ Time Frame: Baseline to 3 weeks ] [ Designated as safety issue: No ]
    Evaluation of visual acuity and refractive status, oculomotor function and visual field status.

  • Change from Baseline in Neuro-Optometric Evaluation at 12 weeks. [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]
    Evaluation of visual acuity and refractive status, oculomotor function and visual field status.


Estimated Enrollment: 80
Study Start Date: January 2012
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01529151

Contacts
Contact: Michelle Yim, MPH (909) 469-8463 vertigoresearch@westernu.edu

Locations
United States, California
Western University Physical Therapy Research Laboratory Recruiting
Pomona, California, United States, 91766
Contact: Michelle Yim, MPH    909-469-8463    vertigoresearch@westernu.edu   
Principal Investigator: Marcel Fraix, DO         
Sponsors and Collaborators
Western University of Health Sciences
Investigators
Principal Investigator: Marcel Fraix, DO Western University of Health Sciences
  More Information

Additional 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
Study First Received: January 31, 2012
Last Updated: March 12, 2012
Health Authority: United States: Institutional Review Board

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:
Dizziness
Vertigo
Labyrinthitis
Labyrinth Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Vestibular Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Otitis

ClinicalTrials.gov processed this record on April 16, 2014