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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Withdrawn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

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

NCT ID

NCT01008124

First Posted

November 4, 2009

Last Updated

March 25, 2021

Sponsor

Midwestern University

Collaborators

Northwestern University

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Withdrawn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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

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

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

Learn more about this trial

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

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