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Treatment of Posterior Canal Type of Benign Paroxysmal Positional Vertigo (PC-BPPV)

Primary Purpose

Benign Paroxysmal Positional Vertigo (BPPV)

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Canalith repositioning maneuver
Sponsored by
Chonbuk National University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Paroxysmal Positional Vertigo (BPPV) focused on measuring Vertigo, Nystagmus, BPPV = benign paroxysmal positional vertigo, Treatment outcome

Eligibility Criteria

10 Years - 90 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. a history of positional vertigo
  2. upbeating-torsional nystagmus in Dix-Hallpike maneuver
  3. absence of identifiable central nervous system disorders that could explain the positional vertigo and nystagmus.

Exclusion Criteria:

(1) 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.

Sites / Locations

  • Chonbuk National University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Canalith repositionig maneuver; Epley maneuver group

Canalith repositioning maneuver : Semont maneuver group

Arm Description

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

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

Outcomes

Primary Outcome Measures

efficacy of repositioning maneuvers for treating PC-BPPV
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.

Secondary Outcome Measures

Full Information

First Posted
March 25, 2013
Last Updated
March 29, 2013
Sponsor
Chonbuk National University
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1. Study Identification

Unique Protocol Identification Number
NCT01822002
Brief Title
Treatment of Posterior Canal Type of Benign Paroxysmal Positional Vertigo
Acronym
PC-BPPV
Official Title
Randomized Controlled Trials for Treatment of Benign Paroxysmal Positional Vertigo
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Unknown status
Study Start Date
February 2013 (undefined)
Primary Completion Date
February 2014 (Anticipated)
Study Completion Date
February 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chonbuk National University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To determine the immediate therapeutic efficacies of canalith repositioning maneuvers in each type of BPPV (posterior canal type, apogeotropic horizontal canal type and geotropic horizontal canal type).
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Paroxysmal Positional Vertigo (BPPV)
Keywords
Vertigo, Nystagmus, BPPV = benign paroxysmal positional vertigo, Treatment outcome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Canalith repositionig maneuver; Epley maneuver group
Arm Type
Active Comparator
Arm Description
Patients with PC-BPPV will be randomly assigned to Epley maneuver or Semont maneuver.
Arm Title
Canalith repositioning maneuver : Semont maneuver group
Arm Type
Active Comparator
Arm Description
Patients with PC-BPPV will be randomly assigned to Epley maneuver or Semont maneuver group.
Intervention Type
Procedure
Intervention Name(s)
Canalith repositioning maneuver
Other Intervention Name(s)
Epley maneuver, Semont maneuver
Primary Outcome Measure Information:
Title
efficacy of repositioning maneuvers for treating PC-BPPV
Description
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.
Time Frame
2hr

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: a history of positional vertigo upbeating-torsional nystagmus in Dix-Hallpike maneuver absence of identifiable central nervous system disorders that could explain the positional vertigo and nystagmus. Exclusion Criteria: (1) 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sun-Young Oh, MD
Phone
82 10 5538 6565
Email
ohsun@jbnu.ac.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Hyo-Jeong Kim
Email
sasakp@naver.com
Facility Information:
Facility Name
Chonbuk National University Hospital
City
Jeonju
ZIP/Postal Code
561 781
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sun-Young Oh, MD
Phone
82 10 5538 6565
Email
ohsun@jbnu.ac.kr
First Name & Middle Initial & Last Name & Degree
Hyu-Jeong Kim
Email
sasakp@naver.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
28755307
Citation
Oh SY, Kim JS, Choi KD, Park JY, Jeong SH, Lee SH, Lee HS, Yang TH, Kim HJ. Switch to Semont maneuver is no better than repetition of Epley maneuver in treating refractory BPPV. J Neurol. 2017 Sep;264(9):1892-1898. doi: 10.1007/s00415-017-8580-2. Epub 2017 Jul 28.
Results Reference
derived

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Treatment of Posterior Canal Type of Benign Paroxysmal Positional Vertigo

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