ClinicalTrials.gg
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.

Primary conditionBenign Paroxysmal Positional VertigoRegistry: VertigoReclassifiedWhy we changed it
Registry
Vertigo — the first condition term the registry derived for this study.
ClinicalTrials.gg
Benign Paroxysmal Positional Vertigo
Why
  1. The study's listed conditions name Benign Paroxysmal Positional Vertigo, a narrower term within Vertigo.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

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

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Keywords

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

In context

Benign Paroxysmal Positional Vertigo Reclassified

75 studies on the registry are indexed under Benign Paroxysmal Positional Vertigo; 15 are open to participants now.

This study's enrollment of 26 is below the median of 78 across 62 interventional studies indexed under Benign Paroxysmal Positional Vertigo.

Browse Benign Paroxysmal Positional Vertigo studies →

Lead sponsor

Western University of Health Sciences is the lead sponsor of 22 studies on the registry; 2 are open to participants now.

Compared within Benign Paroxysmal Positional Vertigo, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Vertigo. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
05

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.

06

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

07

Study locations

1 site
  • Western University Physical Therapy Research Laboratory
    Pomona, California 91766, United States
08

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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Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2012, a primary completion of Aug 2014 and a completion of Aug 2014. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 31, 2012
First posted
Feb 8, 2012
Start
Jan 2012
Primary completionActual
Aug 2014
CompletionActual
Aug 2014
Last update
Jun 10, 2015
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 10, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

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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This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.

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