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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Chonbuk National University
Sponsor:
Information provided by (Responsible Party):
Sun-Young Oh, Chonbuk National University
ClinicalTrials.gov Identifier:
NCT01822002
First received: March 25, 2013
Last updated: March 29, 2013
Last verified: March 2013
  Purpose

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).


Condition Intervention
Benign Paroxysmal Positional Vertigo (BPPV)
Procedure: Canalith repositioning maneuver

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trials for Treatment of Benign Paroxysmal Positional Vertigo

Resource links provided by NLM:


Further study details as provided by Chonbuk National University:

Primary Outcome Measures:
  • efficacy of repositioning maneuvers for treating PC-BPPV [ Time Frame: 2hr ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 1500
Study Start Date: February 2013
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Names:
  • Epley maneuver
  • Semont 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
Other Names:
  • Epley maneuver
  • Semont maneuver

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.

  Eligibility

Ages Eligible for Study:   10 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01822002

Contacts
Contact: Sun-Young Oh, MD 82 10 5538 6565 ohsun@jbnu.ac.kr
Contact: Hyo-Jeong Kim sasakp@naver.com

Locations
Korea, Republic of
Chonbuk National University Hospital Recruiting
Jeonju, Korea, Republic of, 561 781
Contact: Sun-Young Oh, MD    82 10 5538 6565    ohsun@jbnu.ac.kr   
Contact: Hyu-Jeong Kim       sasakp@naver.com   
Sponsors and Collaborators
Chonbuk National University
  More Information

No publications provided

Responsible Party: Sun-Young Oh, Professor, Chonbuk National University
ClinicalTrials.gov Identifier: NCT01822002     History of Changes
Other Study ID Numbers: Treatment of PC-BPPV
Study First Received: March 25, 2013
Last Updated: March 29, 2013
Health Authority: Korea : Korean Food and Drug Administration

Keywords provided by Chonbuk National University:
Vertigo
Nystagmus
BPPV = benign paroxysmal positional vertigo
Treatment outcome

Additional relevant MeSH terms:
Vertigo
Dizziness
Vestibular Diseases
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Sensation Disorders

ClinicalTrials.gov processed this record on September 30, 2014