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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Midwestern University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Northwestern University
Information provided by:
Midwestern University
ClinicalTrials.gov Identifier:
NCT01008124
First received: November 4, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted
  Purpose

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).


Condition Intervention
Vertigo
Vestibular Disease
Other: Liberatory Maneuver
Other: Placebo maneuver

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Liberatory Maneuver for the Treatment of Benign Paroxysmal Positional Vertigo: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Midwestern University:

Primary Outcome Measures:
  • Negative Dix-Hallpike maneuver [ Time Frame: 1-2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Self reported willingness to move [ Time Frame: 1-2 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: November 2009
Estimated Study Completion Date: November 2010
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Liberatory Maneuver
Liberatory Maneuver
Other: Liberatory Maneuver
3 cycles of the liberatory maneuver initial session.
Other Name: Semont Maneuver
Placebo Comparator: Placebo Maneuver
Placebo Maneuver
Other: Placebo maneuver
3 cycles placebo maneuver initial session.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01008124

Locations
United States, Illinois
Chicago Dizziness and Hearing
Chicago, Illinois, United States, 60611
Midwestern University
Downers Grove, Illinois, United States, 60515
Sponsors and Collaborators
Midwestern University
Northwestern University
Investigators
Principal Investigator: Janet O. Helminski, PhD Midwestern University
  More Information

Publications:
Responsible Party: Janet Odry Helminski, PhD, Associate Professor, Midwestern University
ClinicalTrials.gov Identifier: NCT01008124     History of Changes
Other Study ID Numbers: MWU 1718
Study First Received: November 4, 2009
Last Updated: November 4, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Midwestern University:
Benign Paroxysmal Positional Vertigo
BPPV
PC
BPPN
Vertigo

Additional relevant MeSH terms:
Dizziness
Vertigo
Vestibular Diseases
Ear Diseases
Labyrinth Diseases
Nervous System Diseases
Neurologic Manifestations
Otorhinolaryngologic Diseases
Sensation Disorders
Signs and Symptoms

ClinicalTrials.gov processed this record on November 20, 2014