BPPV With CRP: Single Versus Multiple Cycles

NCT ID: NCT02701218

Last Updated: 2019-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2019-12-31

Brief Summary

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Unilateral posterior canal benign paroxysmal positional vertigo (BPPV) cases will be randomized to treat with single or multiple cycles of canalith repositioning procedure.The treatment outcomes will be assessed at 7th and 28th days.

Detailed Description

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Patients present with brief episodes of vertigo will be evaluated by Dix-Hallpike test. Cases with positive Dix-Hallpike test, unilateral, posterior canal, will be randomized with block of four. Either single or multiple cycles of canalith repositioning procedure will be performed. Four treatment outcomes will be blindly assessed at 7 and 28 days.

Conditions

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Benign Paroxysmal Positional Vertigo (BPPV)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Single cycle

single cycle of canalith repositioning procedure

Group Type EXPERIMENTAL

Canalith repositioning procedure

Intervention Type PROCEDURE

Canalith repositioning procedure; single or multiple cycles

multiple cycles of CRP

multiple cycles of canalith repositioning procedure CRP will be stopped if 1) no nystagmus and vertigo in all positions 2) complications exited 3) stable nystagmus in the 2 last cycles

Group Type EXPERIMENTAL

Canalith repositioning procedure

Intervention Type PROCEDURE

Canalith repositioning procedure; single or multiple cycles

Interventions

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Canalith repositioning procedure

Canalith repositioning procedure; single or multiple cycles

Intervention Type PROCEDURE

Other Intervention Names

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Epley's maneuver

Eligibility Criteria

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Inclusion Criteria

1. Recurrent episodes of vertigo
2. 15 years of age or older
3. Positive Dix-Hallpike test: unilateral, posterior canal

Exclusion Criteria

1. Received vestibular suppressant within 6 hours
2. With other diseases or conditions cause of vertigo or central nervous system disease
3. With diseases or conditions contraindicate for Dix-Hallpike test or CRP eg: cervical spine disease, back/ neck stiffness, retinal detachment
4. Positive Dix-Hallpike test: bilateral, other canals
5. Complications from CRP eg: nausea, vomiting, canalith jam
6. Cannot read the questionaire
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chiang Mai University

OTHER

Sponsor Role lead

Responsible Party

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Suwicha Isaradisaikul Kaewsiri

Principal Investigator, Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Suwicha I Kaewsiri, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Otolaryngology

Locations

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Department of Otolaryngology Faculty of Medicine, Chiang Mai University 110 Intawaroros Road, Sriphum

Chiang Mai, , Thailand

Site Status RECRUITING

Countries

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Thailand

Central Contacts

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Suwicha I Kaewsiri, MD

Role: CONTACT

66-816802036

Sanathorn Chowsilpa, MD

Role: CONTACT

66-53935562

Facility Contacts

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Suwicha I Kaewsiri, MD

Role: primary

66-816802036

Sanathorn Chowsilpa, MD

Role: backup

66-53935562

References

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Bhattacharyya N, Baugh RF, Orvidas L, Barrs D, Bronston LJ, Cass S, Chalian AA, Desmond AL, Earll JM, Fife TD, Fuller DC, Judge JO, Mann NR, Rosenfeld RM, Schuring LT, Steiner RW, Whitney SL, Haidari J; American Academy of Otolaryngology-Head and Neck Surgery Foundation. Clinical practice guideline: benign paroxysmal positional vertigo. Otolaryngol Head Neck Surg. 2008 Nov;139(5 Suppl 4):S47-81. doi: 10.1016/j.otohns.2008.08.022.

Reference Type RESULT
PMID: 18973840 (View on PubMed)

Isaradisaikul SK, Chowsilpa S, Hanprasertpong C, Rithirangsriroj T. Single Cycle Versus Multiple Cycles of Canalith Repositioning Procedure for Treatment of Posterior Canal Benign Paroxysmal Positional Vertigo: A Randomized Controlled Trial. Otol Neurotol. 2021 Jan;42(1):121-128. doi: 10.1097/MAO.0000000000002894.

Reference Type DERIVED
PMID: 32947492 (View on PubMed)

Study Documents

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Document Type: Study Protocol

Research administration section website

View Document

Other Identifiers

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ENT-2558-03601

Identifier Type: -

Identifier Source: org_study_id

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