NCT01008124

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).

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2009

Geographic Reach
1 country

2 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

November 4, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 5, 2009

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

March 29, 2021

Status Verified

March 1, 2021

Enrollment Period

1 year

First QC Date

November 4, 2009

Last Update Submit

March 25, 2021

Conditions

VertigoVestibular Disease

Keywords

Benign Paroxysmal Positional VertigoBPPVPCBPPNVertigo

Outcome Measures

Primary Outcomes (1)

  • Negative Dix-Hallpike maneuver

    1-2 weeks

Secondary Outcomes (1)

  • Self reported willingness to move

    1-2 weeks

Study Arms (2)

Liberatory Maneuver

EXPERIMENTAL

Liberatory Maneuver

Other: Liberatory Maneuver

Placebo Maneuver

PLACEBO COMPARATOR

Placebo Maneuver

Other: Placebo maneuver

Interventions

Liberatory ManeuverOTHER

3 cycles of the liberatory maneuver initial session.

Also known as: Semont Maneuver
Liberatory Maneuver
Placebo maneuverOTHER

3 cycles placebo maneuver initial session.

Placebo Maneuver

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BPPV involving the posterior canal on only one side

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Chicago Dizziness and Hearing

Chicago, Illinois, 60611, United States

Location

Midwestern University

Downers Grove, Illinois, 60515, United States

Location

Related Publications (2)

  • 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.

    PMID: 15126738BACKGROUND

  • Massoud EA, Ireland DJ. Post-treatment instructions in the nonsurgical management of benign paroxysmal positional vertigo. J Otolaryngol. 1996 Apr;25(2):121-5.

    PMID: 8683652BACKGROUND

MeSH Terms

Conditions

VertigoVestibular DiseasesBenign Paroxysmal Positional Vertigo

Condition Hierarchy (Ancestors)

Labyrinth DiseasesEar DiseasesOtorhinolaryngologic DiseasesNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Janet O. Helminski, PhD

    Midwestern University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

November 4, 2009

First Posted

November 5, 2009

Study Start

November 1, 2009

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

March 29, 2021

Record last verified: 2021-03

Locations

US(2)