Completed

Treatments for Benign Paroxysmal Positional Vertigo (BPPV)

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Canalith repositioning maneuver (Epley maneuver)

+ Semont maneuver
+ Brandt-Daroff exercises
Behavioral
Who is being recruted

Vertigo

Over 21 Years
+10 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-Controlled
Phase 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, 1998Actual 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.

Official TitleTreatments for Benign Paroxysmal Positional Vertigo (BPPV) 
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 enrolledTotal 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.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How the effectiveness of the treatment is controlled
In a placebo-controlled study, some participants receive the experimental treatment, while others receive an inert substance (placebo) to compare outcomes. This method helps to isolate the effect of the treatment from the psychological effects of receiving any treatment at all.

Other Options
Non-placebo-controlled: No placebo is used. All participants receive the actual treatment or alternative interventions (often the Standard of Care), and comparisons are made between these treatments.

How the interventions assigned to participants is kept confidential
Participants do not know which treatment they are receiving, but researchers do. This helps prevent bias from participants' expectations while still allowing researchers to monitor the study closely.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 21 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Vertigo
Criteria
4 inclusion criteria required to participate
atients 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
6 exclusion criteria prevent from participating
atients 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

Show More Criteria

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
Suspended
Baylor College of MedicineHouston, United StatesSee the location
CompletedOne Study Center