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

Primary Purpose

Vertigo, Dizziness, Benign Paroxysmal Positional Vertigo

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Osteopathic Manipulative Treatment (OMT)
Vestibular Rehabilitation Therapy (VRT)
Sponsored by
Western University of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vertigo focused on measuring Dizziness, Vertigo, Benign Paroxysmal Positional Vertigo, Labyrinthitis, Osteopathic Manipulative Treatment, Vestibular Rehabilitation Therapy

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Western University Physical Therapy Research Laboratory

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

No Intervention

Arm Label

OMT Group

VRT Group

OMT - VRT Group

Control Group

Arm Description

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.

Participants will receive Vestibular Rehabilitation Therapy (VRT), which includes balance exercises in sitting and standing positions that include gaze stabilization, kinesthetic and proprioceptive retraining.

Participants will receive both Osteopathic Manipulative Treatment (OMT) and Vestibular Rehabilitation Therapy (VRT).

Outcomes

Primary Outcome Measures

Change from Baseline in Dizziness Handicap Inventory (DHI) at 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
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
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
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
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
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
Evaluation of visual acuity and refractive status, oculomotor function and visual field status.
Change from Baseline in Neuro-Optometric Evaluation at 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.
Evaluation of visual acuity and refractive status, oculomotor function and visual field status.

Full Information

First Posted
January 31, 2012
Last Updated
June 8, 2015
Sponsor
Western University of Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01529151
Brief Title
Effectiveness of Osteopathic Manipulative Treatment (OMT) and Vestibular Rehabilitation Therapy (VRT) in Individuals With Vertigo
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 Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Western University of Health Sciences

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vertigo, Dizziness, Benign Paroxysmal Positional Vertigo, Labyrinthitis
Keywords
Dizziness, Vertigo, Benign Paroxysmal Positional Vertigo, Labyrinthitis, Osteopathic Manipulative Treatment, Vestibular Rehabilitation Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OMT Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
VRT Group
Arm Type
Active Comparator
Arm Description
Participants will receive Vestibular Rehabilitation Therapy (VRT), which includes balance exercises in sitting and standing positions that include gaze stabilization, kinesthetic and proprioceptive retraining.
Arm Title
OMT - VRT Group
Arm Type
Active Comparator
Arm Description
Participants will receive both Osteopathic Manipulative Treatment (OMT) and Vestibular Rehabilitation Therapy (VRT).
Arm Title
Control Group
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Osteopathic Manipulative Treatment (OMT)
Other Intervention Name(s)
Osteopathic Manipulative Medicine (OMM)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Vestibular Rehabilitation Therapy (VRT)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from Baseline in Dizziness Handicap Inventory (DHI) at 1 week
Description
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.
Time Frame
Baseline to 1 week
Title
Change from Baseline in Dizziness Handicap Inventory (DHI) at 3 weeks
Description
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.
Time Frame
Baseline to 3 weeks
Title
Change from Baseline in Dizziness Handicap Inventory (DHI) at 12 weeks
Description
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.
Time Frame
Baseline to 12 weeks
Title
Change from Baseline in Computerized Dynamic Posturography (CDP) at 1 week
Description
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).
Time Frame
Baseline to 1 week
Title
Change from Baseline in Computerized Dynamic Posturography (CDP) at 3 weeks
Description
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).
Time Frame
Baseline to 3 weeks
Title
Change from Baseline in Computerized Dynamic Posturography (CDP) at 12 weeks
Description
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).
Time Frame
Baseline to 12 weeks
Secondary Outcome Measure Information:
Title
Change from Baseline in Neuro-Optometric Evaluation at 1 week
Description
Evaluation of visual acuity and refractive status, oculomotor function and visual field status.
Time Frame
Baseline to 1 week
Title
Change from Baseline in Neuro-Optometric Evaluation at 3 weeks
Description
Evaluation of visual acuity and refractive status, oculomotor function and visual field status.
Time Frame
Baseline to 3 weeks
Title
Change from Baseline in Neuro-Optometric Evaluation at 12 weeks.
Description
Evaluation of visual acuity and refractive status, oculomotor function and visual field status.
Time Frame
Baseline to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcel Fraix, DO
Organizational Affiliation
Western University of Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Western University Physical Therapy Research Laboratory
City
Pomona
State/Province
California
ZIP/Postal Code
91766
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20659716
Citation
Fraix M. Osteopathic manipulative treatment and vertigo: a pilot study. PM R. 2010 Jul;2(7):612-8. doi: 10.1016/j.pmrj.2010.04.001.
Results Reference
background
PubMed Identifier
33125033
Citation
Fraix M, Badran S, Graham V, Redman-Bentley D, Hurwitz EL, Quan VL, Yim M, Hudson-McKinney M, Seffinger MA. Osteopathic manipulative treatment in individuals with vertigo and somatic dysfunction: a randomized, controlled, comparative feasibility study. J Osteopath Med. 2021 Jan 1;121(1):71-83. doi: 10.7556/jaoa.2020.147.
Results Reference
derived

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

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