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BPPV With CRP: Single Versus Multiple Cycles

Primary Purpose

Benign Paroxysmal Positional Vertigo (BPPV)

Status
Unknown status
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Canalith repositioning procedure
Sponsored by
Chiang Mai University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Paroxysmal Positional Vertigo (BPPV) focused on measuring Canalith repositioning procedure (CRP), BPPV

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Single cycle

multiple cycles of CRP

Arm Description

single cycle of canalith repositioning procedure

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

Outcomes

Primary Outcome Measures

Dix-Hallpike test (DHT)
percentage of negative DHT between single and multiple cycles

Secondary Outcome Measures

Dizziness handicap inventory (DHI)
total score in the questionaire
Dizziness handicap inventory (DHI)
total score in the questionaire
Subjective symptoms
Asking the patient's symptom: Improve, same, worse
Subjective symptoms
Asking the patient's symptom: Improve, same, worse
Loss of balance
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
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)
percentage of negative DHT between single and multiple cycles

Full Information

First Posted
February 18, 2016
Last Updated
July 30, 2019
Sponsor
Chiang Mai University
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1. Study Identification

Unique Protocol Identification Number
NCT02701218
Brief Title
BPPV With CRP: Single Versus Multiple Cycles
Official Title
Comparison of the Treatment Outcomes of Posterior Canal Benign Paroxysmal Positional Vertigo (BPPV) With Canalith Repositioning Procedure (CRP): Single Versus Multiple Cycles
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 2016 (Actual)
Primary Completion Date
March 2019 (Actual)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chiang Mai University

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Paroxysmal Positional Vertigo (BPPV)
Keywords
Canalith repositioning procedure (CRP), BPPV

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
114 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single cycle
Arm Type
Experimental
Arm Description
single cycle of canalith repositioning procedure
Arm Title
multiple cycles of CRP
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Canalith repositioning procedure
Other Intervention Name(s)
Epley's maneuver
Intervention Description
Canalith repositioning procedure; single or multiple cycles
Primary Outcome Measure Information:
Title
Dix-Hallpike test (DHT)
Description
percentage of negative DHT between single and multiple cycles
Time Frame
At 7th day
Secondary Outcome Measure Information:
Title
Dizziness handicap inventory (DHI)
Description
total score in the questionaire
Time Frame
compare to the first visit at 7th between single and multiple cycles
Title
Dizziness handicap inventory (DHI)
Description
total score in the questionaire
Time Frame
compare to the first visit at 28th day between single and multiple cycles
Title
Subjective symptoms
Description
Asking the patient's symptom: Improve, same, worse
Time Frame
Improvement of the symptoms compare to the first visit at 7th day between single and multiple cycles
Title
Subjective symptoms
Description
Asking the patient's symptom: Improve, same, worse
Time Frame
Improvement of the symptoms compare to the first visit at 28th day between single and multiple cycles
Title
Loss of balance
Description
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)
Time Frame
compare to the first visit at 7th between single and multiple cycles
Title
Loss of balance
Description
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)
Time Frame
compare to the first visit at 28th day between single and multiple cycles
Title
Dix-Hallpike test (DHT)
Description
percentage of negative DHT between single and multiple cycles
Time Frame
At 28th day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Suwicha I Kaewsiri, MD
Phone
66-816802036
Email
suwicha.kaewsiri@cmu.ac.th
First Name & Middle Initial & Last Name or Official Title & Degree
Sanathorn Chowsilpa, MD
Phone
66-53935562
Email
sanathornch@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suwicha I Kaewsiri, MD
Organizational Affiliation
Department of Otolaryngology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Otolaryngology Faculty of Medicine, Chiang Mai University 110 Intawaroros Road, Sriphum
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suwicha I Kaewsiri, MD
Phone
66-816802036
Email
suwicha.kaewsiri@cmu.ac.th
First Name & Middle Initial & Last Name & Degree
Sanathorn Chowsilpa, MD
Phone
66-53935562
Email
sanathornch@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
18973840
Citation
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.
Results Reference
result
PubMed Identifier
32947492
Citation
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.
Results Reference
derived
Available IPD and Supporting Information:
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
http://ros.med.cmu.ac.th/Security/SignIn.aspx
Available IPD/Information Identifier
ENT-2558-03601
Available IPD/Information Comments
Research administration section website

Learn more about this trial

BPPV With CRP: Single Versus Multiple Cycles

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