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

Sponsored by:	National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by:	National Institute on Deafness and Other Communication Disorders (NIDCD)
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 Procedure: Semont maneuver Procedure: Brandt-Daroff exercises Procedure: Vestibular habituation exercises Procedure: Epley Maneuver	Phase II

MedlinePlus related topics: Dizziness and Vertigo Exercise and Physical Fitness

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Placebo Control, Efficacy Study
Official Title:	Treatments for Benign Paroxysmal Positional Vertigo (BPPV)

Further study details as provided by National Institute on Deafness and Other Communication Disorders (NIDCD):

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
Epley maneuver: Active Comparator	Behavioral: Epley maneuver Procedure: Epley Maneuver
Semont maneuver: Experimental	Procedure: Semont maneuver
Brandt-Daroff exercises: Experimental	Procedure: Brandt-Daroff exercises
Vestibular habituation exercises: Experimental	Procedure: Vestibular habituation exercises
Epley Maneuver: Experimental	Procedure: Epley Maneuver

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

National Institute on Deafness and Other Communication Disorders (NIDCD)

Investigators

Principal Investigator:

Helen Cohen, EdD

Baylor College of Medicine

More Information

Publications of Results:

Vegunta RK, Wallace LJ, Leonardi MR, Gross TL, Renfroe Y, Marshall JS, Cohen HS, Hocker JR, Macwan KS, Clark SE, Ramiro S, Pearl RH. Perinatal management of gastroschisis: analysis of a newly established clinical pathway. J Pediatr Surg. 2005 Mar;40(3):528-34.

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.

Other Publications:

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:	Baylor College of Medicine ( Helen Cohen, EdD )
Study ID Numbers:	NIDCD-1156, 1 R01 DC03602-01A1
Study First Received:	November 2, 1999
Last Updated:	August 5, 2008
ClinicalTrials.gov Identifier:	NCT00000359
Health Authority:	United States: Federal Government

Keywords provided by National Institute on Deafness and Other Communication Disorders (NIDCD):

Physical Therapy
Vertigo
rehabilitation
occupational therapy

Study placed in the following topic categories:

Signs and Symptoms
Benign paroxysmal positional vertigo
Otorhinolaryngologic Diseases
Neurologic Manifestations

Vestibular Diseases
Ear Diseases
Vertigo

Additional relevant MeSH terms:

Nervous System Diseases
Labyrinth Diseases

ClinicalTrials.gov processed this record on January 15, 2009