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The Liberatory Maneuver for the Treatment of Benign Paroxysmal Positional Vertigo (BPPV) (LM_BPPV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01008124
Recruitment Status : Unknown
Verified November 2009 by Midwestern University.
Recruitment status was:  Active, not recruiting
First Posted : November 5, 2009
Last Update Posted : November 5, 2009
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:
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).

Condition or disease Intervention/treatment
Vertigo Vestibular Disease Other: Liberatory Maneuver Other: Placebo maneuver

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Liberatory Maneuver for the Treatment of Benign Paroxysmal Positional Vertigo: A Randomized Controlled Trial
Study Start Date : November 2009
Estimated Primary Completion Date : November 2010
Estimated Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Liberatory Maneuver
Liberatory Maneuver
Other: Liberatory Maneuver
3 cycles of the liberatory maneuver initial session.
Other Name: Semont Maneuver
Placebo Comparator: Placebo Maneuver
Placebo Maneuver
Other: Placebo maneuver
3 cycles placebo maneuver initial session.


Outcome Measures

Primary Outcome Measures :
  1. Negative Dix-Hallpike maneuver [ Time Frame: 1-2 weeks ]

Secondary Outcome Measures :
  1. Self reported willingness to move [ Time Frame: 1-2 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01008124


Locations
United States, Illinois
Chicago Dizziness and Hearing
Chicago, Illinois, United States, 60611
Midwestern University
Downers Grove, Illinois, United States, 60515
Sponsors and Collaborators
Midwestern University
Northwestern University
Investigators
Principal Investigator: Janet O. Helminski, PhD Midwestern University
More Information

Publications:
Responsible Party: Janet Odry Helminski, PhD, Associate Professor, Midwestern University
ClinicalTrials.gov Identifier: NCT01008124     History of Changes
Other Study ID Numbers: MWU 1718
First Posted: November 5, 2009    Key Record Dates
Last Update Posted: November 5, 2009
Last Verified: November 2009

Keywords provided by Midwestern University:
Benign Paroxysmal Positional Vertigo
BPPV
PC
BPPN
Vertigo

Additional relevant MeSH terms:
Vestibular Diseases
Vertigo
Dizziness
Benign Paroxysmal Positional Vertigo
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Sensation Disorders