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Treatments for Benign Paroxysmal Positional Vertigo (BPPV)

Primary Purpose

Vertigo

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Canalith repositioning maneuver (Epley maneuver)
Semont maneuver
Brandt-Daroff exercises
Vestibular habituation exercises
ShamManeuver
Sponsored by
Baylor College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vertigo focused on measuring Physical Therapy, Vertigo, rehabilitation, occupational therapy

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Baylor College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Sham Comparator

Active Comparator

Active Comparator

Arm Label

Canalith repositioning maneuver

Modified Epley maneuver

Sham

Liberatory maneuver

Brandt Daroff exercise

Arm Description

Repositioning treatment for posterior canal BPPV

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.

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

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

Outcomes

Primary Outcome Measures

Vertigo

Secondary Outcome Measures

Balance

Full Information

First Posted
November 2, 1999
Last Updated
July 25, 2012
Sponsor
Baylor College of Medicine
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
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1. Study Identification

Unique Protocol Identification Number
NCT00000359
Brief Title
Treatments for Benign Paroxysmal Positional Vertigo (BPPV)
Official Title
Treatments for Benign Paroxysmal Positional Vertigo (BPPV)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
October 1998 (undefined)
Primary Completion Date
June 2003 (Actual)
Study Completion Date
June 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vertigo
Keywords
Physical Therapy, Vertigo, rehabilitation, occupational therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Canalith repositioning maneuver
Arm Type
Experimental
Arm Description
Repositioning treatment for posterior canal BPPV
Arm Title
Modified Epley maneuver
Arm Type
Experimental
Arm Title
Sham
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
Liberatory maneuver
Arm Type
Active Comparator
Arm Description
The standard liberatory maneuver (also known as the Semont maneuver) was used.
Arm Title
Brandt Daroff exercise
Arm Type
Active Comparator
Arm Description
Modified Brandt Daroff exercise performed as a self-liberatory exercise.
Intervention Type
Behavioral
Intervention Name(s)
Canalith repositioning maneuver (Epley maneuver)
Other Intervention Name(s)
CRP, Epley maneuver
Intervention Description
Standard passive motion of the head: Dix-Hallpike maneuver, turn head to opposite side, roll over, sit up.
Intervention Type
Behavioral
Intervention Name(s)
Semont maneuver
Other Intervention Name(s)
Liberatory maneuver
Intervention Description
Sidelying maneuver, flip over 180 deg, sit up.
Intervention Type
Behavioral
Intervention Name(s)
Brandt-Daroff exercises
Intervention Description
Active exercise. Sidelying to involved side, sidelying to uninvolved side, sit up.
Intervention Type
Behavioral
Intervention Name(s)
Vestibular habituation exercises
Intervention Description
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
Intervention Name(s)
ShamManeuver
Intervention Description
Passive movement of the head
Primary Outcome Measure Information:
Title
Vertigo
Time Frame
6 month s
Secondary Outcome Measure Information:
Title
Balance
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helen Cohen, EdD
Organizational Affiliation
Baylor College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15021771
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. doi: 10.1097/00129492-200403000-00008.
Results Reference
background
PubMed Identifier
15103195
Citation
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.
Results Reference
result
PubMed Identifier
15011204
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. doi: 10.1016/j.amjoto.2003.09.010.
Results Reference
result
PubMed Identifier
16151355
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. doi: 10.1097/01.mao.0000185044.31276.59.
Results Reference
result

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Treatments for Benign Paroxysmal Positional Vertigo (BPPV)

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