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CompletedNCT01529151Updated Jun 10, 2015

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

An interventional study of Osteopathic Manipulative Treatment (OMT) and Vestibular Rehabilitation Therapy (VRT) in Vertigo, Dizziness and Benign Paroxysmal Positional Vertigo, sponsored by Western University of Health Sciences. Completed at 1 site in United States. Open to participants aged 18 Years to 79 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-06-10.

Sponsored by Western University of Health Sciences · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
26
Allocation
Randomized
Ages
18 Years to 79 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Vertigo
  • Dizziness
  • Benign Paroxysmal Positional Vertigo
  • Labyrinthitis

Keywords

  • Dizziness
  • Vertigo
  • Benign Paroxysmal Positional Vertigo
  • Labyrinthitis
  • Osteopathic Manipulative Treatment
  • Vestibular Rehabilitation Therapy
03

Who can participate

Ages eligible
18 Years to 79 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Single (Care provider)
Enrollment
26 participants (actual)

Study arms

  • 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)

  • 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)

  • Active comparator
    OMT - VRT Group

    Participants will receive both Osteopathic Manipulative Treatment (OMT) and Vestibular Rehabilitation Therapy (VRT).

    Other: Osteopathic Manipulative Treatment (OMT) · Other: Vestibular Rehabilitation Therapy (VRT)

  • No intervention
    Control Group

Interventions

  • OtherOsteopathic 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.

    Also known as: Osteopathic Manipulative Medicine (OMM)

  • OtherVestibular 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.

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline to 1 week

  2. 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.

    Time frame: Baseline to 3 weeks

  3. 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.

    Time frame: Baseline to 12 weeks

  4. 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).

    Time frame: Baseline to 1 week

  5. 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).

    Time frame: Baseline to 3 weeks

  6. 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).

    Time frame: Baseline to 12 weeks

Secondary outcomes

  1. Change from Baseline in Neuro-Optometric Evaluation at 1 week

    Evaluation of visual acuity and refractive status, oculomotor function and visual field status.

    Time frame: Baseline to 1 week

  2. Change from Baseline in Neuro-Optometric Evaluation at 3 weeks

    Evaluation of visual acuity and refractive status, oculomotor function and visual field status.

    Time frame: Baseline to 3 weeks

  3. Change from Baseline in Neuro-Optometric Evaluation at 12 weeks.

    Evaluation of visual acuity and refractive status, oculomotor function and visual field status.

    Time frame: Baseline to 12 weeks

06

Study locations

1 site
  • Western University Physical Therapy Research Laboratory
    Pomona, California 91766, United States
07

References and documents

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. PubMed 20659716 ↗
  • 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. PubMed 33125033 ↗
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Registry details

Key details

Study ID
NCT01529151
Lead sponsor
Western University of Health Sciences
Responsible party
Sponsor
First posted
Feb 8, 2012
Start date
Jan 2012
Primary completion
Aug 2014
Completion
Aug 2014
Last update
Jun 10, 2015

Study contacts

Marcel Fraix, DO
principal investigator · Western University of Health Sciences

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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