Treatments for Benign Paroxysmal Positional Vertigo (BPPV) - Full Text View

Sponsor:	Baylor College of Medicine
Collaborator:	National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by:	Baylor College of Medicine
ClinicalTrials.gov Identifier:	NCT00000359

Purpose

The purpose of this study is 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 Epley maneuver, the 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) shall be assessed. The study will also ascertain 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.

Condition	Intervention	Phase
Vertigo	Behavioral: Epley maneuver Behavioral: Semont maneuver Behavioral: Brandt-Daroff exercises Behavioral: Vestibular habituation exercises Behavioral: ShamManeuver	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Treatments for Benign Paroxysmal Positional Vertigo (BPPV)

Resource links provided by NLM:

Genetics Home Reference related topics: Ménière disease

MedlinePlus related topics: Dizziness and Vertigo Exercise and Physical Fitness

U.S. FDA Resources

Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:

Vertigo [ Time Frame: 6 month s ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Balance [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment:	149
Study Start Date:	October 1998
Study Completion Date:	June 2003
Primary Completion Date:	June 2003 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Epley maneuver Three trials in one visit of canalith repositioning maneuver	Behavioral: Epley maneuver Standard passive motion of the head: Dix-Hallpike maneuver, turn head to opposite side, roll over, sit up. Other Name: Canalith repositioning maneuver Behavioral: ShamManeuver Passive movement of the head
Experimental: Semont maneuver Three trials in one visit on the liberatory maneuver.	Behavioral: Semont maneuver Sidelying maneuver, flip over 180 deg, sit up. Other Name: Liberatory maneuver
Experimental: Brandt-Daroff exercises The subject was instructed in performing the standard Brandt Daroff exercise three times per day.	Behavioral: Brandt-Daroff exercises Active exercise. Sidelying to involved side, sidelying to uninvolved side, sit up.
Experimental: Vestibular habituation exercises Standard vertigo habituation exercises, involving head shaking in pitch, roll, yaw and circumduction, sitting and standing, were used.	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.
Sham Comparator: ShamManeuver Slow passive head movement in downward pitch, away from the involved side and thn up again.	Behavioral: ShamManeuver Passive movement of the head

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000359

Locations

United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030

Sponsors and Collaborators

Baylor College of Medicine

National Institute on Deafness and Other Communication Disorders (NIDCD)

Investigators

Principal Investigator:

Helen Cohen, EdD

Baylor College of Medicine

More Information

Publications:

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

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.

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

Responsible Party:	Helen Cohen, EdD, Baylor College of Medicine
ClinicalTrials.gov Identifier:	NCT00000359 History of Changes
Other Study ID Numbers:	NIDCD-1156, R01DC003602, 1 R01 DC03602-01A1
Study First Received:	November 2, 1999
Last Updated:	May 25, 2010
Health Authority:	United States: Federal Government

Keywords provided by Baylor College of Medicine:

Physical Therapy
Vertigo
rehabilitation
occupational therapy

Additional relevant MeSH terms:

Vertigo
Dizziness
Vestibular Diseases
Labyrinth Diseases
Ear Diseases

Otorhinolaryngologic Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Sensation Disorders

ClinicalTrials.gov processed this record on February 08, 2012