Clinical trial NCT01529151: 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
Overall status: COMPLETED
Phase: NA
Conditions: Vertigo
Dizziness
Benign Paroxysmal Positional Vertigo
Labyrinthitis
Keywords: Dizziness
Vertigo
Benign Paroxysmal Positional Vertigo
Labyrinthitis
Osteopathic Manipulative Treatment
Vestibular Rehabilitation Therapy
Lead sponsor: Western University of Health Sciences
Sponsor class: OTHER
First posted: 2012-02-08
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change from Baseline in Dizziness Handicap Inventory (DHI) at 1 week
timeFrame: Baseline to 1 week
measure: Change from Baseline in Dizziness Handicap Inventory (DHI) at 3 weeks
timeFrame: Baseline to 3 weeks
measure: Change from Baseline in Dizziness Handicap Inventory (DHI) at 12 weeks
timeFrame: Baseline to 12 weeks
measure: Change from Baseline in Computerized Dynamic Posturography (CDP) at 1 week
timeFrame: Baseline to 1 week
measure: Change from Baseline in Computerized Dynamic Posturography (CDP) at 3 weeks
timeFrame: Baseline to 3 weeks
measure: Change from Baseline in Computerized Dynamic Posturography (CDP) at 12 weeks
timeFrame: Baseline to 12 weeks
Secondary outcomes:
measure: Change from Baseline in Neuro-Optometric Evaluation at 1 week
timeFrame: Baseline to 1 week
measure: Change from Baseline in Neuro-Optometric Evaluation at 3 weeks
timeFrame: Baseline to 3 weeks
measure: Change from Baseline in Neuro-Optometric Evaluation at 12 weeks.
timeFrame: Baseline to 12 weeks
Other outcomes:
Locations:
city: Pomona
country: United States
facility: Western University Physical Therapy Research Laboratory
state: California
Study officials:
affiliation: Western University of Health Sciences
name: Marcel Fraix, DO
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.