Treatments for Benign Paroxysmal Positional Vertigo (BPPV)

NCT ID: NCT00000359

Last Updated: 2012-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-10-31

Study Completion Date

2003-06-30

Brief Summary

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The purpose of this study was to determine the relative short- and long-term efficacy of several physical treatment paradigms commonly employed for the treatment of benign paroxysmal positional vertigo (BPPV), including the canalith repositioning (Epley) maneuver, the liberatory (Semont) maneuver, the Brandt-Daroff exercises and nonspecific vestibular habituation exercises. These procedures involve exercises and head manipulations. Vertigo intensity and frequency, the presence/absence of slow-phase eye movements, the degree of dizziness handicap and acts of daily living (ADL) were assessed. The study also ascertained the effects of co-morbid conditions on the response to treatment. While BPPV is a common and significant public health problem that has been recognized for several decades, this is the first systematic study of the relative treatment efficacy of different physical treatment modalities for this disorder.

Detailed Description

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Conditions

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Vertigo

Keywords

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Physical Therapy Vertigo rehabilitation occupational therapy

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Canalith repositioning maneuver

Repositioning treatment for posterior canal BPPV

Group Type EXPERIMENTAL

Canalith repositioning maneuver (Epley maneuver)

Intervention Type BEHAVIORAL

Standard passive motion of the head: Dix-Hallpike maneuver, turn head to opposite side, roll over, sit up.

Modified Epley maneuver

Group Type EXPERIMENTAL

Vestibular habituation exercises

Intervention Type BEHAVIORAL

Head shaking exercises in pitch, roll, yaw and circumduction. Titrating from 2 repetitions per exercise to 20 repetitions per exercise, as tolerated.

Sham

The subject sat in a chair; the head was passively tilted downward, turned away from the involved side, turned back to center, upward, away from the involved side, twice, slowly.

Group Type SHAM_COMPARATOR

ShamManeuver

Intervention Type BEHAVIORAL

Passive movement of the head

Liberatory maneuver

The standard liberatory maneuver (also known as the Semont maneuver) was used.

Group Type ACTIVE_COMPARATOR

Semont maneuver

Intervention Type BEHAVIORAL

Sidelying maneuver, flip over 180 deg, sit up.

Brandt Daroff exercise

Modified Brandt Daroff exercise performed as a self-liberatory exercise.

Group Type ACTIVE_COMPARATOR

Brandt-Daroff exercises

Intervention Type BEHAVIORAL

Active exercise. Sidelying to involved side, sidelying to uninvolved side, sit up.

Interventions

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Canalith repositioning maneuver (Epley maneuver)

Standard passive motion of the head: Dix-Hallpike maneuver, turn head to opposite side, roll over, sit up.

Intervention Type BEHAVIORAL

Semont maneuver

Sidelying maneuver, flip over 180 deg, sit up.

Intervention Type BEHAVIORAL

Brandt-Daroff exercises

Active exercise. Sidelying to involved side, sidelying to uninvolved side, sit up.

Intervention Type BEHAVIORAL

Vestibular habituation exercises

Head shaking exercises in pitch, roll, yaw and circumduction. Titrating from 2 repetitions per exercise to 20 repetitions per exercise, as tolerated.

Intervention Type BEHAVIORAL

ShamManeuver

Passive movement of the head

Intervention Type BEHAVIORAL

Other Intervention Names

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CRP Epley maneuver Liberatory maneuver

Eligibility Criteria

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Inclusion Criteria

Patients may be eligible for this study if they:

* Are at least 21 years old.
* Have a diagnosis of unilateral posterior semicircular canal BPPV according to established clinical test criteria.
* Have functional to normal range of motion of the neck and the back.

Exclusion Criteria

Patients will not be eligible for this study if they:

* Have a history of prior ear surgery or prior treatment for BPPV.
* Have an orthopedic or connective tissue disorder that impairs functional neck or trunk range of motion.
* Have a significant neurological disorder or spinal cord damage.
* Are on vestibular suppressant medications.
* Have Meniere's disease or acoustic neuromas.
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

Sponsor Role collaborator

Baylor College of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Helen Cohen

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Helen Cohen, EdD

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Locations

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Baylor College of Medicine

Houston, Texas, United States

Site Status

Countries

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United States

References

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Cohen HS. Side-lying as an alternative to the Dix-Hallpike test of the posterior canal. Otol Neurotol. 2004 Mar;25(2):130-4. doi: 10.1097/00129492-200403000-00008.

Reference Type BACKGROUND
PMID: 15021771 (View on PubMed)

Cohen HS, Kimball KT, Stewart MG. Benign paroxysmal positional vertigo and comorbid conditions. ORL J Otorhinolaryngol Relat Spec. 2004;66(1):11-5. doi: 10.1159/000077227.

Reference Type RESULT
PMID: 15103195 (View on PubMed)

Cohen HS, Kimball KT. Treatment variations on the Epley maneuver for benign paroxysmal positional vertigo. Am J Otolaryngol. 2004 Jan-Feb;25(1):33-7. doi: 10.1016/j.amjoto.2003.09.010.

Reference Type RESULT
PMID: 15011204 (View on PubMed)

Cohen HS, Kimball KT. Effectiveness of treatments for benign paroxysmal positional vertigo of the posterior canal. Otol Neurotol. 2005 Sep;26(5):1034-40. doi: 10.1097/01.mao.0000185044.31276.59.

Reference Type RESULT
PMID: 16151355 (View on PubMed)

Other Identifiers

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R01DC003602

Identifier Type: NIH

Identifier Source: secondary_id

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1R01DC003602-01A1

Identifier Type: NIH

Identifier Source: secondary_id

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NIDCD-1156

Identifier Type: -

Identifier Source: org_study_id