BPPV With CRP: Single Versus Multiple Cycles

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

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.

Study Overview

• Status: Unknown
• Conditions: Benign Paroxysmal Positional Vertigo (BPPV)
• Intervention / Treatment: Procedure: Canalith repositioning procedure

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 Type: Interventional
• Enrollment (Anticipated): 114
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Chiang Mai, Thailand, 50200
    • Recruiting
    • Department of Otolaryngology Faculty of Medicine, Chiang Mai University 110 Intawaroros Road, Sriphum
    • Contact: Suwicha I Kaewsiri, MD; Phone Number: 66-816802036; Email: suwicha.kaewsiri@cmu.ac.th
    • Contact: Sanathorn Chowsilpa, MD; Phone Number: 66-53935562; Email: sanathornch@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dix-Hallpike test (DHT)	percentage of negative DHT between single and multiple cycles	At 7th day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dizziness handicap inventory (DHI)	total score in the questionaire	compare to the first visit at 7th between single and multiple cycles
Dizziness handicap inventory (DHI)	total score in the questionaire	compare to the first visit at 28th day between single and multiple cycles
Subjective symptoms	Asking the patient's symptom: Improve, same, worse	Improvement of the symptoms compare to the first visit at 7th day between single and multiple cycles
Subjective symptoms	Asking the patient's symptom: Improve, same, worse	Improvement of the symptoms compare to the first visit at 28th day between single and multiple cycles
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)	compare to the first visit at 7th between single and multiple cycles
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)	compare to the first visit at 28th day between single and multiple cycles
Dix-Hallpike test (DHT)	percentage of negative DHT between single and multiple cycles	At 28th day

Collaborators and Investigators

• Sponsor: Chiang Mai University
• Investigators: Principal Investigator: Suwicha I Kaewsiri, MD, Department of Otolaryngology

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2016
• Primary Completion (ACTUAL): March 1, 2019
• Study Completion (ANTICIPATED): December 1, 2019

Study Registration Dates

• First Submitted: February 18, 2016
• First Submitted That Met QC Criteria: March 2, 2016
• First Posted (ESTIMATE): March 8, 2016

Study Record Updates

• Last Update Posted (ACTUAL): July 31, 2019
• Last Update Submitted That Met QC Criteria: July 30, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: BPPV; Canalith repositioning procedure (CRP)
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Labyrinth Diseases; Ear Diseases; Vestibular Diseases; Sensation Disorders; Vertigo; Benign Paroxysmal Positional Vertigo; Dizziness
• Other Study ID Numbers: ENT-2558-03601

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Study Data/Documents

1. Study Protocol
   Information identifier: ENT-2558-03601
   Information comments: Research administration section website