Completed

Treatments for Benign Paroxysmal Positional Vertigo (BPPV)

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What is being tested

Canalith repositioning maneuver (Epley maneuver)

+ Vestibular habituation exercises

+ ShamManeuver

Behavioral
Who is being recruted

Ear Diseases+6

+ Labyrinth Diseases

+ Nervous System Diseases

Over 21 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 2
Interventional
Study Start: October 1998
See protocol details

Summary

Principal SponsorBaylor College of Medicine
Last updated: July 26, 2012
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 1998

Actual date on which the first participant was enrolled.

The purpose of this study was to determine the relative short- and long-term efficacy of several physical treatment paradigms commonly employed for the treatment of benign paroxysmal positional vertigo (BPPV), including the canalith repositioning (Epley) maneuver, the liberatory (Semont) maneuver, the Brandt-Daroff exercises and nonspecific vestibular habituation exercises. These procedures involve exercises and head manipulations. Vertigo intensity and frequency, the presence/absence of slow-phase eye movements, the degree of dizziness handicap and acts of daily living (ADL) were assessed. The study also ascertained the effects of co-morbid conditions on the response to treatment. While BPPV is a common and significant public health problem that has been recognized for several decades, this is the first systematic study of the relative treatment efficacy of different physical treatment modalities for this disorder.

NCT00000359
Principal SponsorBaylor College of Medicine
Last updated: July 26, 2012
Sourced from a government-validated database.Claim as a partner

Protocol

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

150 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 21 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Ear DiseasesLabyrinth DiseasesNervous System DiseasesNeurologic ManifestationsOtorhinolaryngologic DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsVestibular DiseasesVertigo

Criteria

Inclusion Criteria: Patients may be eligible for this study if they: Are at least 21 years old. Have a diagnosis of unilateral posterior semicircular canal BPPV according to established clinical test criteria. Have functional to normal range of motion of the neck and the back. Exclusion Criteria: Patients will not be eligible for this study if they: Have a history of prior ear surgery or prior treatment for BPPV. Have an orthopedic or connective tissue disorder that impairs functional neck or trunk range of motion. Have a significant neurological disorder or spinal cord damage. Are on vestibular suppressant medications. Have Meniere's disease or acoustic neuromas.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

5 intervention groups are designated in this study

20% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Repositioning treatment for posterior canal BPPV

Group II

Experimental

Group III

Sham
The subject sat in a chair; the head was passively tilted downward, turned away from the involved side, turned back to center, upward, away from the involved side, twice, slowly.

Group IV

Active Comparator
The standard liberatory maneuver (also known as the Semont maneuver) was used.

Group 5

Active Comparator
Modified Brandt Daroff exercise performed as a self-liberatory exercise.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Baylor College of Medicine

Houston, United StatesOpen Baylor College of Medicine in Google Maps
CompletedOne Study Center