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Completed

NCT Number: NCT01529151

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

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.

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Key information

Conditions

Vertigo Benign Paroxysmal Positional Vertigo Dizziness Ear Diseases Labyrinth Diseases Labyrinthitis Nervous System Diseases Neurologic Manifestations Otitis Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Vestibular Diseases

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Western University Physical Therapy Research Laboratory

Pomona, California, 91766, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Osteopathic Manipulative Treatment (OMT)

Other

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 names: Osteopathic Manipulative Medicine (OMM)

Vestibular Rehabilitation Therapy (VRT)

Other

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Western University of Health Sciences

Other

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Feb 8, 2012
Registry last updated
Jun 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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