Suspended

PC-BPPVRandomized Controlled Trials for Treatment of Benign Paroxysmal Positional Vertigo

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What is being tested

Canalith repositioning maneuver

+ Canalith repositioning maneuver

Procedure
Who is being recruted

Cranial Nerve Diseases+11

+ Ear Diseases

+ Eye Diseases

From 10 to 90 Years
+4 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: February 2013
See protocol details

Summary

Principal SponsorChonbuk National University
Study ContactSun-Young Oh, MDMore contacts
Last updated: April 1, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2013

Actual date on which the first participant was enrolled.

In nationwide 10 Dizziness Clinics of Korea, consecutive patients with each type of BPPV are randomized to each repositioning maneuver. For posterior canal type of BPPV (PC-BPPV), patinets are randomized into modified Epley maneuver and Semont maneuver. Subjects Consecutive patients with a diagnosis of PC-BPPV are recruited from nationwide 10 Dizziness Clinics in Korea. The inclusion criteria for this study were (1) a history of positional vertigo, (2) direction-changing positional nystagmus appropriate for each type of BPPV, and (3) absence of identifiable central nervous system disorders that could explain the positional vertigo and nystagmus. To exclude the patients with nystagmus from central pathologies, all patients also will receive neurotological examinations including spontaneous and gaze-evoked (GEN) nystagmus, horizontal and vertical smooth pursuit and saccades, limb ataxia, and balance function in addition to routine neurological examinations. Even in patients with isolated vertigo, those with central ocular motor signs, limb ataxia, and severe imbalance will be arranged for MRIs. Diagnostic procedure To induce positional nystagmus, the patients lied supine from sitting (lying-down nystagmus) and turned their heads to either side while in supine (head-turning nystagmus). Then the patients were moved from a supine to sitting position and the head was bent down (head-bending nystagmus). Patients were also subjected to right and left Hallpike maneuvers and straight head hanging test to exclude BPPV involving the posterior or anterior canal. Study design and Randomization The investigators attempt to determine the immediate therapeutic efficacies of Epley maneuver and Semont maneuver for PC-BPPV, repeated barbecue rotation maneuver and Gufoni maneuver after barbecue rotatio maneuver for geotropic HC-BPPV, and repeated Gufoni maneuver and head-shaking maneuvers after Gufoni maneuver in apogeotropic HC-BPPV by adopting a prospective randomized controlled study design. Based on the data from the pilot study, the investigators estimated the proportion of immediate resolution would be 60-70% in the repositioning groups. By adopting 0.9 power to detect a significant difference (p=0.05, two-sided) and a drop rate of 5%, 200 patients of each type of BPPV will be required for each treatment arm. The immediate treatment response will be determined by participating neurologists in each clinic without knowing the maneuver applied to each patient from 30 minutes to one hour after initial maneuver. The absence of both vertigo and nystagmus will be required to determine a resolution. When the patient still show positioning nystagmus or vertigo, the patient will be received the another maneuver at each protocol arm.

Principal SponsorChonbuk National University
Study ContactSun-Young Oh, MDMore contacts
Last updated: April 1, 2013
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

1500 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.

From 10 to 90 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

Cranial Nerve DiseasesEar DiseasesEye DiseasesLabyrinth DiseasesNervous System DiseasesNeurologic ManifestationsOtorhinolaryngologic DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsOcular Motility DisordersVestibular DiseasesNystagmus, PathologicVertigoBenign Paroxysmal Positional Vertigo

Criteria

3 inclusion criteria required to participate
a history of positional vertigo

absence of identifiable central nervous system disorders that could explain the positional vertigo and nystagmus

upbeating-torsional nystagmus in Dix-Hallpike maneuver

1 exclusion criteria prevent from participating
Patients with positive neurotological examinations including spontaneous and gaze-evoked (GEN) nystagmus, horizontal and vertical smooth pursuit and saccades, limb ataxia, and balance function in addition to routine neurological examinations

Study Plan

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

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
Patients with PC-BPPV will be randomly assigned to Epley maneuver or Semont maneuver.

Group II

Active Comparator
Patients with PC-BPPV will be randomly assigned to Epley maneuver or Semont maneuver group.

Study Objectives

Primary 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

Recruiting

Chonbuk National University Hospital

Jeonju, South KoreaOpen Chonbuk National University Hospital in Google Maps
SuspendedOne Study Center