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Withdrawn

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:
  • Semont Maneuver
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.

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.

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

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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