- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00000359
Treatments for Benign Paroxysmal Positional Vertigo (BPPV)
July 25, 2012 updated by: Helen Cohen, Baylor College of Medicine
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
150
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
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Houston, Texas, United States, 77030
- Baylor College of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Canalith repositioning maneuver
Repositioning treatment for posterior canal BPPV
|
Standard passive motion of the head: Dix-Hallpike maneuver, turn head to opposite side, roll over, sit up.
Other Names:
|
|
Experimental: Modified Epley maneuver
|
Head shaking exercises in pitch, roll, yaw and circumduction.
Titrating from 2 repetitions per exercise to 20 repetitions per exercise, as tolerated.
|
|
Sham Comparator: Sham
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.
|
Passive movement of the head
|
|
Active Comparator: Liberatory maneuver
The standard liberatory maneuver (also known as the Semont maneuver) was used.
|
Sidelying maneuver, flip over 180 deg, sit up.
Other Names:
|
|
Active Comparator: Brandt Daroff exercise
Modified Brandt Daroff exercise performed as a self-liberatory exercise.
|
Active exercise.
Sidelying to involved side, sidelying to uninvolved side, sit up.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Vertigo
Time Frame: 6 month s
|
6 month s
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Balance
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Helen Cohen, EdD, Baylor College of Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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. doi: 10.1097/00129492-200403000-00008.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 1998
Primary Completion (Actual)
June 1, 2003
Study Completion (Actual)
June 1, 2003
Study Registration Dates
First Submitted
November 2, 1999
First Submitted That Met QC Criteria
November 2, 1999
First Posted (Estimate)
November 3, 1999
Study Record Updates
Last Update Posted (Estimate)
July 26, 2012
Last Update Submitted That Met QC Criteria
July 25, 2012
Last Verified
July 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NIDCD-1156
- R01DC003602 (U.S. NIH Grant/Contract)
- 1R01DC003602-01A1 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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