Effects of Physical Treatment on Postural Stability in Benign Paroxysmal Positional Vertigo (BPPV) Patients

April 16, 2015 updated by: Assuta Hospital Systems

Epley Maneuver vs. Semont Maneuver for Benign Paroxysmal Positional Vertigo (BPPV): Evaluating Treatment Effectiveness by Postural Stability - a Double Blinded Randomized Controlled Trial.

The propose of this study is to compare two methods of physical treatment for benign paroxysmal positional vertigo, by evaluating treatment effects on postural stability.

The trail design is a double blinded randomized controlled trail, with each patient going through three evaluations: before treatment, 1 week after treatment and 60 days after treatment.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Beer Sheva, Israel
        • Maccabi Health Services

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • medical referral for treating "vertigo"
  • subject has short episodes of rotatory vertigo (up to 1 minute)
  • subject has positive Hallpike-Dix test with typical nystagmus
  • repeated Hallpike-dix test will show fatigability

Exclusion Criteria:

  • Hallpike-Dix test produces vertigo without nystagmus
  • subject has BPPV of the horizontal or anterior semi-circular canal
  • subject has other known vestibular or neurologic condition
  • subject has nystagmus of a different type
  • subject has a cervical spine problem which prevents the utilization of Epley or Semont maneuvers
  • subject is unable to stand for 1 minute
  • subject gets pharmacologic treatment for vertigo while doing the postural stability evaluation
  • subject is under 18 years old or a pregnant female or cannot obtain informed concent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Semont
BPPV patients treated by Semont maneuver by a physical therapist.
Other: Semont maneuver
Other Names:
  • liberatory manoeuvre
No Intervention: control
healthy volunteers.
Active Comparator: Epley maneuver
BPPV patients treated with Epley maneuver by a physical therapist.
Other: Epley maneuver
Other Names:
  • canalith repositioning maneuver

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
postural stability
Time Frame: 60 days post treatment
60 days post treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
subjective vertigo
Time Frame: 60 days post treatment
60 days post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assuta Hospital Systems

Collaborators

Ben-Gurion University of the Negev

Investigators

  • Study Chair: Itshak Melzer, Dr, Ben-Gurion University of the Negev
  • Study Director: Moshe Puterman, Dr, Soroka University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Anticipated)

June 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

September 16, 2009

First Submitted That Met QC Criteria

September 16, 2009

First Posted (Estimate)

September 17, 2009

Study Record Updates

Last Update Posted (Estimate)

April 17, 2015

Last Update Submitted That Met QC Criteria

April 16, 2015

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BPPV-2
  • 2009051

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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