Effectiveness of Osteopathic Manipulative Treatment (OMT) and Vestibular Rehabilitation Therapy (VRT) in Individuals With Vertigo
2 other identifiers
interventional
26
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2012
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
January 31, 2012
CompletedFirst Posted
Study publicly available on registry
February 8, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedJune 10, 2015
June 1, 2015
2.6 years
January 31, 2012
June 8, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
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.
Baseline to 1 week
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.
Baseline to 3 weeks
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.
Baseline to 12 weeks
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).
Baseline to 1 week
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).
Baseline to 3 weeks
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).
Baseline to 12 weeks
Secondary Outcomes (3)
Change from Baseline in Neuro-Optometric Evaluation at 1 week
Baseline to 1 week
Change from Baseline in Neuro-Optometric Evaluation at 3 weeks
Baseline to 3 weeks
Change from Baseline in Neuro-Optometric Evaluation at 12 weeks.
Baseline to 12 weeks
Study Arms (4)
OMT Group
ACTIVE COMPARATORParticipants 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.
VRT Group
ACTIVE COMPARATORParticipants will receive Vestibular Rehabilitation Therapy (VRT), which includes balance exercises in sitting and standing positions that include gaze stabilization, kinesthetic and proprioceptive retraining.
OMT - VRT Group
ACTIVE COMPARATORParticipants will receive both Osteopathic Manipulative Treatment (OMT) and Vestibular Rehabilitation Therapy (VRT).
Control Group
NO INTERVENTIONInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Western University Physical Therapy Research Laboratory
Pomona, California, 91766, United States
Related Publications (2)
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.
PMID: 20659716BACKGROUNDFraix 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.
PMID: 33125033DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marcel Fraix, DO
Western University of Health Sciences
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 31, 2012
First Posted
February 8, 2012
Study Start
January 1, 2012
Primary Completion
August 1, 2014
Study Completion
August 1, 2014
Last Updated
June 10, 2015
Record last verified: 2015-06