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

Dizziness Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01529151
• Other study ID #: 11/IRB/033
• Secondary ID: 11-13-647
• Status: Completed
• Phase: N/A
• First received: January 31, 2012
• Last updated: June 8, 2015
• Start date: January 2012
• Est. completion date: August 2014

Study information

• Verified date: June 2015
• Source: Western University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 79 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Benign Paroxysmal Positional Vertigo
• Dizziness
• Labyrinth Diseases
• Labyrinthitis
• Vertigo

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Western University Physical Therapy Research Laboratory	Pomona	California

Sponsors (1)

Lead Sponsor	Collaborator
Western University of Health Sciences

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	Change from Baseline in Neuro-Optometric Evaluation at 1 week	Evaluation of visual acuity and refractive status, oculomotor function and visual field status.	Baseline to 1 week	No
Secondary	Change from Baseline in Neuro-Optometric Evaluation at 3 weeks	Evaluation of visual acuity and refractive status, oculomotor function and visual field status.	Baseline to 3 weeks	No
Secondary	Change from Baseline in Neuro-Optometric Evaluation at 12 weeks.	Evaluation of visual acuity and refractive status, oculomotor function and visual field status.	Baseline to 12 weeks	No

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