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

• ClinicalTrials.gov Identifier: NCT01529151
• Recruitment Status: Completed
• First Posted: February 8, 2012
• Last Update Posted: June 10, 2015
• Sponsor: Western University of Health Sciences
• Information provided by (Responsible Party): Western University of Health Sciences

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	Phase
Vertigo; Dizziness; Benign Paroxysmal Positional Vertigo; Labyrinthitis	Other: Osteopathic Manipulative Treatment (OMT); Other: Vestibular Rehabilitation Therapy (VRT)	Not Applicable

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
• Actual Primary Completion Date: August 2014
• Actual 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

• Ages Eligible for Study: 18 Years to 79 Years (Adult, Older Adult)
• 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

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:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Western University of Health Sciences
• ClinicalTrials.gov Identifier: NCT01529151
• 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
• 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; Benign Paroxysmal Positional Vertigo; Labyrinthitis; Labyrinth Diseases; Dizziness; Vestibular Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Sensation Disorders; Otitis