BPPV With CRP: Single Versus Multiple Cycles

Sponsor

Chiang Mai University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02701218

Collaborator

(none)

114

Enrollment

Location

Arms

Anticipated Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Benign Paroxysmal Positional Vertigo (BPPV)	Procedure: Canalith repositioning procedure	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

114 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Comparison of the Treatment Outcomes of Posterior Canal Benign Paroxysmal Positional Vertigo (BPPV) With Canalith Repositioning Procedure (CRP): Single Versus Multiple Cycles

Actual Study Start Date :

Feb 1, 2016

Actual Primary Completion Date :

Mar 1, 2019

Anticipated Study Completion Date :

Dec 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Single cycle single cycle of canalith repositioning procedure	Procedure: Canalith repositioning procedure Canalith repositioning procedure; single or multiple cycles Other Names: Epley's maneuver
Experimental: 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	Procedure: Canalith repositioning procedure Canalith repositioning procedure; single or multiple cycles Other Names: Epley's maneuver

Arm

Intervention/Treatment

Experimental: Single cycle

single cycle of canalith repositioning procedure

Procedure: Canalith repositioning procedure

Canalith repositioning procedure; single or multiple cycles

Other Names:

Epley's maneuver

Experimental: 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

Procedure: Canalith repositioning procedure

Canalith repositioning procedure; single or multiple cycles

Other Names:

Epley's maneuver

Outcome Measures

Primary Outcome Measures

Dix-Hallpike test (DHT) [At 7th day]
percentage of negative DHT between single and multiple cycles

Secondary Outcome Measures

Dizziness handicap inventory (DHI) [compare to the first visit at 7th between single and multiple cycles]
total score in the questionaire
Dizziness handicap inventory (DHI) [compare to the first visit at 28th day between single and multiple cycles]
total score in the questionaire
Subjective symptoms [Improvement of the symptoms compare to the first visit at 7th day between single and multiple cycles]
Asking the patient's symptom: Improve, same, worse
Subjective symptoms [Improvement of the symptoms compare to the first visit at 28th day between single and multiple cycles]
Asking the patient's symptom: Improve, same, worse
Loss of balance [compare to the first visit at 7th between single and multiple cycles]
5 levels Level 1: Able to continue daily activities without any helps. Level 2: Able to continue daily activities without any helps except complicated activities such as riding a bicycle, walking on counterpoise or scaffolding. Level 3: Not able to continue daily activities without help excepts simple activities such as self-care, housework, walking, or being a passenger in a vehicle Level 4: Not able to continue daily activities alone without help except self-care Level 5 Not able to continue daily activities alone without help except self-care without ambulation. Need to stay only in a house or a living place. (From: The Royal college of Otolaryngologists head and neck surgeons of Thailand, and social security office of thailand)
Loss of balance [compare to the first visit at 28th day between single and multiple cycles]
5 levels Level 1: Able to continue daily activities without any helps. Level 2: Able to continue daily activities without any helps except complicated activities such as riding a bicycle, walking on counterpoise or scaffolding. Level 3: Not able to continue daily activities without help excepts simple activities such as self-care, housework, walking, or being a passenger in a vehicle Level 4: Not able to continue daily activities alone without help except self-care Level 5 Not able to continue daily activities alone without help except self-care without ambulation. Need to stay only in a house or a living place. (From: The Royal college of Otolaryngologists head and neck surgeons of Thailand, and social security office of thailand)
Dix-Hallpike test (DHT) [At 28th day]
percentage of negative DHT between single and multiple cycles

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Otolaryngology Faculty of Medicine, Chiang Mai University 110 Intawaroros Road, Sriphum	Chiang Mai		Thailand	50200

Sponsors and Collaborators

Chiang Mai University

Investigators

Principal Investigator: Suwicha I Kaewsiri, MD, Department of Otolaryngology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Suwicha Isaradisaikul Kaewsiri, Principal Investigator, Clinical Professor, Chiang Mai University

ClinicalTrials.gov Identifier:

NCT02701218

Other Study ID Numbers:

ENT-2558-03601

First Posted:

Mar 8, 2016

Last Update Posted:

Jul 31, 2019

Last Verified:

Jul 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Keywords provided by Suwicha Isaradisaikul Kaewsiri, Principal Investigator, Clinical Professor, Chiang Mai University

Canalith repositioning procedure (CRP)

BPPV

Additional relevant MeSH terms:

Vertigo

Benign Paroxysmal Positional Vertigo

Dizziness

Study Results

No Results Posted as of Jul 31, 2019