VertigoNCT01529151
Effectiveness of Osteopathic Manipulative Treatment (OMT) and Vestibular Rehabilitation Therapy (VRT) in Individuals With Vertigo
A study testing Osteopathic Manipulative Treatment (OMT) and Vestibular Rehabilitation Therapy (VRT) in people with Vertigo and Dizziness, run by Western University of Health Sciences at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Vertigo, Dizziness, Benign Paroxysmal Positional Vertigo
- What is being tested?
- Osteopathic Manipulative Treatment (OMT) and Vestibular Rehabilitation Therapy (VRT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Western University Physical Therapy Research Laboratory
Pomona, California, 91766
About this study
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
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.
- Being tested
- Osteopathic Manipulative Treatment (OMT), Vestibular Rehabilitation Therapy (VRT)
- Keywords
- Dizziness, Vertigo, Benign Paroxysmal Positional Vertigo, Labyrinthitis, Osteopathic Manipulative Treatment, Vestibular Rehabilitation Therapy
- Medical subject headings
- Vertigo, Dizziness, Benign Paroxysmal Positional Vertigo, Labyrinthitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic Manipulative Treatment (OMT)Other
Also called Osteopathic Manipulative Medicine (OMM)
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)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.
| Study group | Role | What they receive |
|---|---|---|
| OMT Group | Active comparator | 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. Receives: Other: Osteopathic Manipulative Treatment (OMT) |
| VRT Group | Active comparator | Participants will receive Vestibular Rehabilitation Therapy (VRT), which includes balance exercises in sitting and standing positions that include gaze stabilization, kinesthetic and proprioceptive retraining. Receives: Other: Vestibular Rehabilitation Therapy (VRT) |
| OMT - VRT Group | Active comparator | Participants will receive both Osteopathic Manipulative Treatment (OMT) and Vestibular Rehabilitation Therapy (VRT). Receives: Other: Osteopathic Manipulative Treatment (OMT); Other: Vestibular Rehabilitation Therapy (VRT) |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 1 week
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.
Measured: Baseline to 3 weeks
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.
Measured: Baseline to 12 weeks
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).
Measured: Baseline to 1 week
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).
Measured: Baseline to 3 weeks
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).
Measured: Baseline to 12 weeks
Secondary outcomes (3)
Change from Baseline in Neuro-Optometric Evaluation at 1 week
Evaluation of visual acuity and refractive status, oculomotor function and visual field status.
Measured: Baseline to 1 week
Change from Baseline in Neuro-Optometric Evaluation at 3 weeks
Evaluation of visual acuity and refractive status, oculomotor function and visual field status.
Measured: Baseline to 3 weeks
Change from Baseline in Neuro-Optometric Evaluation at 12 weeks.
Evaluation of visual acuity and refractive status, oculomotor function and visual field status.
Measured: Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2012 (estimated)
- Study startJan 2012
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for VertigoStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marcel Fraix, DO, Principal investigator, Western University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01529151
- Sponsor's protocol ID
- 11/IRB/033
- Other IDs
- 11-13-647
- Status last verified
- Jun 2015
- First submitted
- 31 Jan 2012
- Last updated
- 10 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
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 20659716Fraix 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
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01529151
- Acronym / sponsor ID
- 11/IRB/033
- Keywords
- Dizziness, Vertigo, Benign Paroxysmal Positional Vertigo, Labyrinthitis, Osteopathic Manipulative Treatment, Vestibular Rehabilitation Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Western University of Health SciencesUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 8 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| OMT Group | Active comparator | Other: Osteopathic Manipulative Treatment (OMT)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. |
| VRT Group | Active comparator | Other: Vestibular Rehabilitation Therapy (VRT)Participants will receive Vestibular Rehabilitation Therapy (VRT), which includes balance exercises in sitting and standing positions that include gaze stabilization, kinesthetic and proprioceptive retraining. |
| OMT - VRT Group | Active comparator | Other: Osteopathic Manipulative Treatment (OMT), Other: Vestibular Rehabilitation Therapy (VRT)Participants will receive both Osteopathic Manipulative Treatment (OMT) and Vestibular Rehabilitation Therapy (VRT). |
| Control Group | No intervention | – |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Osteopathic Manipulative Treatment (OMT)Also: Osteopathic Manipulative Medicine (OMM)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 | OMT - VRT Group, OMT Group |
| 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. | Other | OMT - VRT Group, VRT Group |
Primary outcome
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.
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.
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.
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).
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).
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).
3 secondary outcomes
Change from Baseline in Neuro-Optometric Evaluation at 1 week
Time frame: Baseline to 1 week
Change from Baseline in Neuro-Optometric Evaluation at 3 weeks
Time frame: Baseline to 3 weeks
Change from Baseline in Neuro-Optometric Evaluation at 12 weeks.
Time frame: Baseline to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2015.
- Background: PubMed 20659716Fraix 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.
- Derived from this study: PubMed 33125033Fraix 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcel Fraix, DO principal investigator
Western University of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteopathic Manipulative Treatment (OMT) and Vestibular Rehabilitation Therapy (VRT) in people with Vertigo and Dizziness, run by Western University of Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Dizziness Handicap Inventory (DHI) at 1 week (time frame: Baseline to 1 week). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01529151, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2015.