The Treatment of Posterior Semicircular Canal Benign Paroxysmal Positional Vertigo (BPPV)
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|ClinicalTrials.gov Identifier: NCT02029508|
Recruitment Status : Completed
First Posted : January 8, 2014
Last Update Posted : January 8, 2014
|Condition or disease||Intervention/treatment||Phase|
|Benign Paroxysmal Positional Vertigo||Procedure: Modified Epley maneuver Procedure: Semont maneuver Procedure: Reverse Epley maneuver||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||99 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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 Start Date :||October 2012|
|Actual Primary Completion Date :||February 2013|
|Actual Study Completion Date :||June 2013|
Active Comparator: Epley maneuver
The group using modified Epley maneuver for PSCC BPPV
Procedure: Modified Epley maneuver
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.
Active Comparator: Semont maneuver
The group using Semont maneuver for PSCC BPPV
Procedure: Semont maneuver
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.
Sham Comparator: Sham
The group using Reverse Epley maneuver for PSCC BPPV
Procedure: Reverse Epley maneuver
Like the modified Epley maneuver, but the direction was reverse.
- Initial Effectiveness of Treatment for the Posterior Semicircular Canal Benign Paroxysmal Positional Vertigo [ Time Frame: 20 minutes ]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.
- Delayed Effectiveness of Treatment for the Posterior Semicircular Canal Benign Paroxysmal Positional Vertigo [ Time Frame: 1, 7 day ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02029508
|Korea, Republic of|
|Asan Medical Center|
|Seoul, Songpa-gu, Korea, Republic of, 138-736|
|Study Director:||Hongju Park, Professor||Asan Medical Center|