The Liberatory Maneuver for the Treatment of Benign Parox... | NCT01008124

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

NCT01008124

Sponsor

Midwestern University

Status

Withdrawn

Last Update Posted

Mar 29, 2021Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Vertigo
Vestibular Disease

Interventions

Liberatory Maneuver
Placebo maneuver

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2021

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Never recruited/started study

Expanded Access Info

Start Date

Nov 2009Estimated

Primary Completion Date

Nov 2010Estimated

Completion Date

Nov 2010Estimated

First Submitted Date

Nov 4, 2009

First Submission Date that Met QC Criteria

Nov 4, 2009

First Posted Date

Nov 5, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 25, 2021

Last Update Posted Date

Mar 29, 2021Actual

Name	Class
Northwestern University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Liberatory Maneuver	Experimental	Liberatory Maneuver	Other: Liberatory Maneuver
Placebo Maneuver	Placebo Comparator	Placebo Maneuver	Other: Placebo maneuver

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Liberatory Maneuver	Other	3 cycles of the liberatory maneuver initial session.	Liberatory Maneuver

Measure	Description	Time Frame
Negative Dix-Hallpike maneuver		1-2 weeks

Measure	Description	Time Frame
Self reported willingness to move		1-2 weeks

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Janet O. Helminski, PhD	Midwestern University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chicago Dizziness and Hearing		Chicago	Illinois	60611	United States
Midwestern University

References Module

Citations

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

ID	Term
D014717	Vertigo
D015837	Vestibular Diseases
D065635	Benign Paroxysmal Positional Vertigo

ID	Term
D007759	Labyrinth Diseases
D004427	Ear Diseases
D010038	Otorhinolaryngologic Diseases
D009461	Neurologic Manifestations