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

Primary Purpose

Vertigo, Vestibular Disease

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Liberatory Maneuver
Placebo maneuver
Sponsored by
Midwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vertigo focused on measuring Benign Paroxysmal Positional Vertigo, BPPV, PC, BPPN, Vertigo

Eligibility Criteria

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

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.

Sites / Locations

  • Chicago Dizziness and Hearing
  • Midwestern University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Liberatory Maneuver

Placebo Maneuver

Arm Description

Liberatory Maneuver

Placebo Maneuver

Outcomes

Primary Outcome Measures

Negative Dix-Hallpike maneuver

Secondary Outcome Measures

Self reported willingness to move

Full Information

First Posted
November 4, 2009
Last Updated
March 25, 2021
Sponsor
Midwestern University
Collaborators
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT01008124
Brief Title
The Liberatory Maneuver for the Treatment of Benign Paroxysmal Positional Vertigo (BPPV)
Acronym
LM_BPPV
Official Title
The Liberatory Maneuver for the Treatment of Benign Paroxysmal Positional Vertigo: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Never recruited/started study
Study Start Date
November 2009 (Anticipated)
Primary Completion Date
November 2010 (Anticipated)
Study Completion Date
November 2010 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Midwestern University
Collaborators
Northwestern University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vertigo, Vestibular Disease
Keywords
Benign Paroxysmal Positional Vertigo, BPPV, PC, BPPN, Vertigo

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Liberatory Maneuver
Arm Type
Experimental
Arm Description
Liberatory Maneuver
Arm Title
Placebo Maneuver
Arm Type
Placebo Comparator
Arm Description
Placebo Maneuver
Intervention Type
Other
Intervention Name(s)
Liberatory Maneuver
Other Intervention Name(s)
Semont Maneuver
Intervention Description
3 cycles of the liberatory maneuver initial session.
Intervention Type
Other
Intervention Name(s)
Placebo maneuver
Intervention Description
3 cycles placebo maneuver initial session.
Primary Outcome Measure Information:
Title
Negative Dix-Hallpike maneuver
Time Frame
1-2 weeks
Secondary Outcome Measure Information:
Title
Self reported willingness to move
Time Frame
1-2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janet O. Helminski, PhD
Organizational Affiliation
Midwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chicago Dizziness and Hearing
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Midwestern University
City
Downers Grove
State/Province
Illinois
ZIP/Postal Code
60515
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15126738
Citation
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.
Results Reference
background
PubMed Identifier
8683652
Citation
Massoud EA, Ireland DJ. Post-treatment instructions in the nonsurgical management of benign paroxysmal positional vertigo. J Otolaryngol. 1996 Apr;25(2):121-5.
Results Reference
background

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

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