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

NCT ID: NCT01529151

Last Updated: 2015-06-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2014-08-31

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.

Conditions

Vertigo; Dizziness; Benign Paroxysmal Positional Vertigo; Labyrinthitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Osteopathic Manipulative Treatment (OMT)

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Vestibular Rehabilitation Therapy (VRT)

Intervention Type: 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.

OMT - VRT Group

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

Group Type: ACTIVE_COMPARATOR

Osteopathic Manipulative Treatment (OMT)

Intervention Type: 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.

Vestibular Rehabilitation Therapy (VRT)

Intervention Type: 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.

Control Group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Osteopathic 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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

Other Intervention Names

Osteopathic Manipulative Medicine (OMM)

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Western University of Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marcel Fraix, DO

Role: PRINCIPAL_INVESTIGATOR

Western University of Health Sciences

Locations

Western University Physical Therapy Research Laboratory

Pomona, California, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 20659716 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33125033 (View on PubMed)

Other Identifiers

11-13-647

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

11/IRB/033

Identifier Type: -

Identifier Source: org_study_id