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| Name | Class |
|---|---|
| Seoul National University Bundang Hospital | OTHER |
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The purpose of this study was to compare the immediate efficacies of each treatment maneuvers in treatment of apogeotropic horizontal canal benign paroxysmal positional vertigo (HC-BPPV).
A randomized prospective study of patients with HC-BPPV. Patients with apogeotropic type of HC-BPPV were randomized to one of each three treatment groups at their first clinic visit. These groups included the Gufoni maneuver, head-shaking maneuver, and sham group in apogeotropic HC-BPPV. Responsiveness of treatment maneuver was determined by positioning maneuver immediately after each treatment method based on resolves of vertigo and positional nystagmus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gufoni maneuver | Active Comparator | Gufoni maneuver for apogeotropic HC-BPPV |
|
| Headshaking maneuver | Active Comparator | headshaking maneuver for apogeotropic HC BPPV |
|
| sham maneuver | Sham Comparator | sham maneuver for apogeotropic HC BPPV |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gufoni maneuver | Procedure | For Gufoni maneuver,16,18 the patient was quickly brought down to the side-lying position on the affected ear from the sitting position. After one minute in this position, the head of the patient was quickly turned 45O upward, so that the nose directed upward. Approximately 2 minutes later, the patient was returned to the upright position (Figure 2A). |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment of Apogeotropic Horizontal Canal Benign Paroxysmal Positional Vertigo: A Randomized Clinical Trial | The immediate treatment response was 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 was required to determine a resolution. | one hour |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chonbuk National University Hospital | Jeonju | Cholabuk-do | 560-712 | South Korea | ||
| Seoul National University Bundang Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22170885 | Derived | Kim JS, Oh SY, Lee SH, Kang JH, Kim DU, Jeong SH, Choi KD, Moon IS, Kim BK, Oh HJ, Kim HJ. Randomized clinical trial for apogeotropic horizontal canal benign paroxysmal positional vertigo. Neurology. 2012 Jan 17;78(3):159-66. doi: 10.1212/WNL.0b013e31823fcd26. Epub 2011 Dec 14. |
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We defined the transition as a conversion into another canal type of BPPV without intervening periods of remission. In contrast, recurrence was defined as a redevelopment of any type of BPPV after a confirmed resolution of the positioning nystagmus and vertigo.
Between February 2009 and October 2009, consecutive patients with a diagnosis of apogeotropic HC-BPPV were recruited from nationwide 10 Dizziness Clinics in Korea.
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| ID | Title | Description |
|---|---|---|
| FG000 | Gufoni Maneuver | Gufoni maneuver for apogeotropic HC-BPPV |
| FG001 | Headshaking Maneuver | headshaking maneuver for apogeotropic HC BPPV |
| FG002 | Sham Maneuver | sham maneuver for apogeotropci HC BPPV |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Gufoni Maneuver | Gufoni maneuver for apogeotropic HC-BPPV |
| BG001 | Headshaking Maneuver | headshaking maneuver for apogeotropic HC BPPV |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Treatment of Apogeotropic Horizontal Canal Benign Paroxysmal Positional Vertigo: A Randomized Clinical Trial | The immediate treatment response was 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 was required to determine a resolution. | Of the 157 patients enrolled in the study, three were lost for follow-up (dropout rate, 1.9%) and 154 were finally included for analyses. | Posted | Number | 95% Confidence Interval | participants | one hour |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Gufoni Maneuver | Gufoni maneuver for apogeotropic HC-BPPV |
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In this study, resolution of BPPV was determined using a telephone interview during the follow-ups after one week.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Treatment of apogeotropic HC BPPV | KONOS | 82 10 5538 6565 | ohsun@jbnu.ac.kr |
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| ID | Term |
|---|---|
| D065635 | Benign Paroxysmal Positional Vertigo |
| D009759 | Nystagmus, Pathologic |
| ID | Term |
|---|---|
| D014717 | Vertigo |
| D015837 | Vestibular Diseases |
| D007759 | Labyrinth Diseases |
| D004427 | Ear Diseases |
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|
| Head-shaking maneuver | Procedure | For head-shaking maneuver,15 patients were brought into a sitting position. After pitching the head forward by approximately 30O, we moved the head sideways in a sinusoidal fashion at an approximate rate of 3 Hz for 15 seconds. |
|
| sham maneuver | Procedure | For the sham maneuver, patients quickly lied on the unaffected side, and returned to the sitting position after one minute. |
|
| Seongnam |
| Kyoungki-do |
| South Korea |
| BG002 | Sham Maneuver | sham maneuver for apogeotropci HC BPPV |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
headshaking maneuver for apogeotropic HC BPPV |
| OG002 | Sham Maneuver | sham maneuver for apogeotropci HC BPPV |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Headshaking Maneuver | headshaking maneuver for apogeotropic HC BPPV | 0 | 0 | 0 | 0 |
| EG002 | Sham Maneuver | sham maneuver for apogeotropci HC BPPV | 0 | 0 | 0 | 0 |
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| D010038 |
| Otorhinolaryngologic Diseases |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015835 | Ocular Motility Disorders |
| D003389 | Cranial Nerve Diseases |
| D005128 | Eye Diseases |