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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
Sponsor:
Information provided by (Responsible Party):
Hong Ju Park, Asan Medical Center

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.

Condition or disease Intervention/treatment Phase
Benign Paroxysmal Positional Vertigo Procedure: Modified Epley maneuver Procedure: Semont maneuver Procedure: Reverse Epley maneuver Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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Korea, Republic of
Asan Medical Center
Seoul, Songpa-gu, Korea, Republic of, 138-736
Sponsors and Collaborators
Asan Medical Center
Investigators
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Study Director: Hongju Park, Professor Asan Medical Center

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Responsible Party: Hong Ju Park, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT02029508     History of Changes
Other Study ID Numbers: PSCC_BPPV_Kr
First Posted: January 8, 2014    Key Record Dates
Last Update Posted: January 8, 2014
Last Verified: January 2014
Keywords provided by Hong Ju Park, Asan Medical Center:
PSCC(Posterior semicircular canal)
BPPV(Bening paroxysmal positional vertigo)
Vertigo
Otorhinolaryngologic Diseases
Additional relevant MeSH terms:
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Vertigo
Benign Paroxysmal Positional Vertigo
Dizziness
Vestibular Diseases
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Sensation Disorders