The Treatment of Posterior Semicircular Canal Benign Paroxysmal Positional Vertigo (BPPV)
Primary Purpose
Benign Paroxysmal Positional Vertigo
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Modified Epley maneuver
Semont maneuver
Reverse Epley maneuver
Sponsored by
About this trial
This is an interventional treatment trial for Benign Paroxysmal Positional Vertigo focused on measuring PSCC(Posterior semicircular canal), BPPV(Bening paroxysmal positional vertigo), Vertigo, Otorhinolaryngologic Diseases
Eligibility Criteria
Inclusion Criteria:
- a symptom of positional vertigo
- rotational and upbeating nystagmus in Dix-Hallpike test
- the nystagmus should be disappear within 60 seconds
- no spontaneous nystagmus
Exclusion Criteria:
- ages under 18 years
- suspicious or verified a central nervous system lesion
- traumatic vertigo patients
- other otologic disease(acute/chronic otitis media, otosclerosis, etc)
- other vestibular disease(vestibular neuronitis, Meniere's disease, etc)
- congenital nystagmus patients
- the patients with spinal disease
- the patients with the limitation of cervical movement
Sites / Locations
- Asan Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Sham Comparator
Arm Label
Epley maneuver
Semont maneuver
Sham
Arm Description
The group using modified Epley maneuver for PSCC BPPV
The group using Semont maneuver for PSCC BPPV
The group using Reverse Epley maneuver for PSCC BPPV
Outcomes
Primary Outcome Measures
Initial Effectiveness of Treatment for the Posterior Semicircular Canal Benign Paroxysmal Positional Vertigo
The immediate effectiveness of treatment was determined by otolaryngologists with the Dix-Hallpike test 20 minutes after initial manerver applied. The investigator had no information of the treatment applied to the patient. The complete resolution means absence of nystagmus and paroxysmal vertigo symptom. If there was a sustained nystagmus, the latency and duration was measured.
Secondary Outcome Measures
Delayed Effectiveness of Treatment for the Posterior Semicircular Canal Benign Paroxysmal Positional Vertigo
Ather 1 day and 7 days after the initial treatment was applied, the patients were re-visit the clinic and re-examined with the Dix-Hallpike test. The absence of nystagmus and vertigo was determinded.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02029508
Brief Title
The Treatment of Posterior Semicircular Canal Benign Paroxysmal Positional Vertigo
Acronym
BPPV
Official Title
The Effectiveness Comparison of Three Different Methods for the Treatment of Posterior Semicircular Canal Benign Paroxysmal Positional Vertigo: Prospective, Double Blinded, Randomized, Multicenter Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study was to compare the treatment effectiveness of three different methods for posterior semicircular canal benign paroxysmal positional vertigo. The included methods are Modified Epley maneuver, Semont maneuver and Sham maneuver.
Detailed Description
This study was a prospective, double blinded, randomized, multicenter clinical trial. The enrolled posterior semicircular canal benign paroxysmal positional vertigo patients were randomized to one of the three treatment regimens when they are diagnosed with the Dix-Hallpike test. An then the patient was treated with one of the three maneuvers. After 20 minutes, the patient was examined with the Dix-Hallpike test again. The resolution of nystagmus and symptoms were checked. When the nystagmus was sustained, the same treatment was applied once again. And after 20 minutes, the patient was examined with the Dix-Hallpike test too. 1 day after and 7 days after, the patient was re-examined with the Dix-Hallpike test.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Paroxysmal Positional Vertigo
Keywords
PSCC(Posterior semicircular canal), BPPV(Bening paroxysmal positional vertigo), Vertigo, Otorhinolaryngologic Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
99 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Epley maneuver
Arm Type
Active Comparator
Arm Description
The group using modified Epley maneuver for PSCC BPPV
Arm Title
Semont maneuver
Arm Type
Active Comparator
Arm Description
The group using Semont maneuver for PSCC BPPV
Arm Title
Sham
Arm Type
Sham Comparator
Arm Description
The group using Reverse Epley maneuver for PSCC BPPV
Intervention Type
Procedure
Intervention Name(s)
Modified Epley maneuver
Intervention Description
For Modified Epley maneuver, the patient was placed in the upright position with the head turned 45 degrees toward the affected ear. And then the patient was rapidly laid back to the supine head-hanging position for 1 minute. Next, the head was turned 90 degrees toward the other (unaffected) side for 1 minute. Next, the head is turned a further 90 degrees (usually necessitating the patient's body to also move from the supine position to the lateral decubitus position) such that the patient' head is nearly in the facedown position for 1 minute. The patient is then brought into the upright sitting position for 1 minute, completing the maneuver.
Intervention Type
Procedure
Intervention Name(s)
Semont maneuver
Intervention Description
Patient's head was turned 45 degrees toward the healthy side. And then patient was rapidly moved to affected side-lying position and sustained for 2 minutes. Next, Patient is rapidly taken to the opposite side-lying position without pausing in the sitting position or changing the head position relative to the shoulder for 2 minutes. Next, Patient returns slowly with the head still tilted and fixed until the seated position for 1 minute.
Intervention Type
Procedure
Intervention Name(s)
Reverse Epley maneuver
Intervention Description
Like the modified Epley maneuver, but the direction was reverse.
Primary Outcome Measure Information:
Title
Initial Effectiveness of Treatment for the Posterior Semicircular Canal Benign Paroxysmal Positional Vertigo
Description
The immediate effectiveness of treatment was determined by otolaryngologists with the Dix-Hallpike test 20 minutes after initial manerver applied. The investigator had no information of the treatment applied to the patient. The complete resolution means absence of nystagmus and paroxysmal vertigo symptom. If there was a sustained nystagmus, the latency and duration was measured.
Time Frame
20 minutes
Secondary Outcome Measure Information:
Title
Delayed Effectiveness of Treatment for the Posterior Semicircular Canal Benign Paroxysmal Positional Vertigo
Description
Ather 1 day and 7 days after the initial treatment was applied, the patients were re-visit the clinic and re-examined with the Dix-Hallpike test. The absence of nystagmus and vertigo was determinded.
Time Frame
1, 7 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
a symptom of positional vertigo
rotational and upbeating nystagmus in Dix-Hallpike test
the nystagmus should be disappear within 60 seconds
no spontaneous nystagmus
Exclusion Criteria:
ages under 18 years
suspicious or verified a central nervous system lesion
traumatic vertigo patients
other otologic disease(acute/chronic otitis media, otosclerosis, etc)
other vestibular disease(vestibular neuronitis, Meniere's disease, etc)
congenital nystagmus patients
the patients with spinal disease
the patients with the limitation of cervical movement
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hongju Park, Professor
Organizational Affiliation
Asan Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
State/Province
Songpa-gu
ZIP/Postal Code
138-736
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
The Treatment of Posterior Semicircular Canal Benign Paroxysmal Positional Vertigo
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