Treatment of Posterior Canal Type of Benign Paroxysmal Positional Vertigo (PC-BPPV)
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|ClinicalTrials.gov Identifier: NCT01822002|
Recruitment Status : Unknown
Verified March 2013 by Sun-Young Oh, Chonbuk National University.
Recruitment status was: Recruiting
First Posted : April 1, 2013
Last Update Posted : April 1, 2013
|Condition or disease||Intervention/treatment|
|Benign Paroxysmal Positional Vertigo (BPPV)||Procedure: Canalith repositioning maneuver|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1500 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Randomized Controlled Trials for Treatment of Benign Paroxysmal Positional Vertigo|
|Study Start Date :||February 2013|
|Estimated Primary Completion Date :||February 2014|
|Estimated Study Completion Date :||February 2015|
Active Comparator: Canalith repositionig maneuver; Epley maneuver group
Patients with PC-BPPV will be randomly assigned to Epley maneuver or Semont maneuver.
Procedure: Canalith repositioning maneuver
Active Comparator: Canalith repositioning maneuver : Semont maneuver group
Patients with PC-BPPV will be randomly assigned to Epley maneuver or Semont maneuver group.
Procedure: Canalith repositioning maneuver
- efficacy of repositioning maneuvers for treating PC-BPPV [ Time Frame: 2hr ]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.
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): NCT01822002
|Korea, Republic of|
|Chonbuk National University Hospital||Recruiting|
|Jeonju, Korea, Republic of, 561 781|
|Contact: Sun-Young Oh, MD 82 10 5538 6565 email@example.com|
|Contact: Hyu-Jeong Kim firstname.lastname@example.org|