- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01008124
The Liberatory Maneuver for the Treatment of Benign Paroxysmal Positional Vertigo (BPPV) (LM_BPPV)
March 25, 2021 updated by: Janet Odry Helminski, PhD, Midwestern University
The Liberatory Maneuver for the Treatment of Benign Paroxysmal Positional Vertigo: A Randomized Controlled Trial
This study is being done because the investigators would like to know how effective the Liberatory maneuver is in treating benign paroxysmal positional vertigo (BPPV).
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Detailed Description
BPPV is a problem with the inner ear that causes brief periods of vertigo triggered by changes in the position of the head such as rolling, looking up, or bending down.
BPPV is presently thought to be caused by small pieces of debris or crystals becoming displaced within the inner ear.
It can be treated by moving the patient through a series of positions called a maneuver.
There are 2 different maneuvers currently used to treat BPPV by the clinician called the liberatory maneuver and the canalith repositioning procedure.
We would like to determine how effective the liberatory maneuver is in the treatment of BPPV compared to a placebo maneuver.
Study Type
Interventional
Phase
- Not Applicable
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
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Chicago Dizziness and Hearing
-
Downers Grove, Illinois, United States, 60515
- Midwestern University
-
-
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- BPPV involving the posterior canal on only one side
Exclusion Criteria:
- No other canals involved (anterior canal or lateral canal), no central nervous system disorder, and no other medical condition that would not enable the individual to have the maneuver done.
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
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Liberatory Maneuver
|
3 cycles of the liberatory maneuver initial session.
Other Names:
|
Placebo Comparator: Placebo Maneuver
|
3 cycles placebo maneuver initial session.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Negative Dix-Hallpike maneuver
Time Frame: 1-2 weeks
|
1-2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Self reported willingness to move
Time Frame: 1-2 weeks
|
1-2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Janet O. Helminski, PhD, Midwestern University
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
- Salvinelli F, Trivelli M, Casale M, Firrisi L, Di Peco V, D'Ascanio L, Greco F, Miele A, Petitti T, Bernabei R. Treatment of benign positional vertigo in the elderly: a randomized trial. Laryngoscope. 2004 May;114(5):827-31. doi: 10.1097/00005537-200405000-00007.
- Massoud EA, Ireland DJ. Post-treatment instructions in the nonsurgical management of benign paroxysmal positional vertigo. J Otolaryngol. 1996 Apr;25(2):121-5.
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 (Anticipated)
November 1, 2009
Primary Completion (Anticipated)
November 1, 2010
Study Completion (Anticipated)
November 1, 2010
Study Registration Dates
First Submitted
November 4, 2009
First Submitted That Met QC Criteria
November 4, 2009
First Posted (Estimate)
November 5, 2009
Study Record Updates
Last Update Posted (Actual)
March 29, 2021
Last Update Submitted That Met QC Criteria
March 25, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MWU 1718
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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Clinical Trials on Liberatory Maneuver
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University of AlexandriaCompletedAcute Respiratory Distress SyndromeEgypt
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University of ZurichCompletedBenign Paroxysmal Positional VertigoSwitzerland
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Day General Hospital.Shahid Beheshti University of Medical SciencesCompleted
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