Treatments for Benign Paroxysmal Positional Vertigo (BPPV)

NCT00000359 | Completed Phase 2

• 3 other identifiers: NIDCD-1156R01DC0036021R01DC003602-01A1
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Vertigo

Keywords

Physical Therapy; Vertigo; rehabilitation; occupational therapy

Outcome Measures

Primary Outcomes (1)

• Vertigo

  6 month s

Secondary Outcomes (1)

• Balance

  6 months

Study Arms (5)

Canalith repositioning maneuver

EXPERIMENTAL

Repositioning treatment for posterior canal BPPV

Behavioral: Canalith repositioning maneuver (Epley maneuver)

Modified Epley maneuver

EXPERIMENTAL

Behavioral: Vestibular habituation exercises

Sham

SHAM COMPARATOR

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.

Behavioral: ShamManeuver

Liberatory maneuver

ACTIVE COMPARATOR

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

Behavioral: Semont maneuver

Brandt Daroff exercise

ACTIVE COMPARATOR

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

Behavioral: Brandt-Daroff exercises

Interventions

Canalith repositioning maneuver (Epley maneuver) BEHAVIORAL

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

Also known as: CRP, Epley maneuver

Canalith repositioning maneuver

Semont maneuver BEHAVIORAL

Sidelying maneuver, flip over 180 deg, sit up.

Also known as: Liberatory maneuver

Liberatory maneuver

Brandt-Daroff exercises BEHAVIORAL

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

Brandt Daroff exercise

Vestibular habituation exercises BEHAVIORAL

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

Modified Epley maneuver

ShamManeuver BEHAVIORAL

Passive movement of the head

Sham

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baylor College of Medicine: lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Related Publications (4)

• 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.

  PMID: 15021771 BACKGROUND

• 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.

  PMID: 15103195 RESULT

• 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.

  PMID: 15011204 RESULT

• 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.

  PMID: 16151355 RESULT

MeSH Terms

Conditions

Vertigo

Condition Hierarchy (Ancestors)

Vestibular Diseases; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Helen Cohen, EdD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: November 3, 1999
• Study Start: October 1, 1998
• Primary Completion: June 1, 2003
• Study Completion: June 1, 2003
• Last Updated: July 26, 2012

Record last verified: 2012-07

Locations

US (1)