Treatments for Benign Paroxysmal Positional Vertigo (BPPV)

Vertigo Clinical Trial

Official title:

Treatments for Benign Paroxysmal Positional Vertigo (BPPV)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000359
• Other study ID #: NIDCD-1156
• Secondary ID: R01DC0036021R01D
• Status: Completed
• Phase: Phase 2
• First received: November 2, 1999
• Last updated: July 25, 2012
• Start date: October 1998
• Est. completion date: June 2003

Study information

• Verified date: July 2012
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: June 2003
• Est. primary completion date: June 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dizziness
• Vertigo

Intervention

Behavioral:
• Canalith repositioning maneuver (Epley maneuver)
Standard passive motion of the head: Dix-Hallpike maneuver, turn head to opposite side, roll over, sit up.
• Semont maneuver
Sidelying maneuver, flip over 180 deg, sit up.
• Brandt-Daroff exercises
Active exercise. Sidelying to involved side, sidelying to uninvolved side, sit up.
• 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.
• ShamManeuver
Passive movement of the head

Locations

Country	Name	City	State
United States	Baylor College of Medicine	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Baylor College of Medicine	National Institute on Deafness and Other Communication Disorders (NIDCD)

Country where clinical trial is conducted

United States, 

References & Publications (4)

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

Cohen HS, Kimball KT. Effectiveness of treatments for benign paroxysmal positional vertigo of the posterior canal. Otol Neurotol. 2005 Sep;26(5):1034-40. — View Citation

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vertigo		6 month s	No
Secondary	Balance		6 months	No