BPPV With CRP: Single Versus Multiple Cycles

Not Applicable

• Conditions: Benign Paroxysmal Positional Vertigo (BPPV)
• Interventions: Procedure: Canalith repositioning procedure

• Registration Number: NCT02701218
• Lead Sponsor: Chiang Mai University

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.

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-02-18
• Study First Submitted QC: 2016-03-02
• Study First Posted: 2016-03-08
• Primary Completion: 2019-03
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-30
• Last Update Posted: 2019-07-31
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 114

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single cycle	Canalith repositioning procedure	single cycle of canalith repositioning procedure
multiple cycles of CRP	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

Primary Outcome Measures

Name	Time	Method
Dix-Hallpike test (DHT)	At 7th day	percentage of negative DHT between single and multiple cycles

Secondary Outcome Measures

Name	Time	Method
Dizziness handicap inventory (DHI)	compare to the first visit at 28th day between single and multiple cycles	total score in the questionaire
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
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

Trial Locations

Locations (1)

Department of Otolaryngology Faculty of Medicine, Chiang Mai University 110 Intawaroros Road, Sriphum; 🇹🇭 Chiang Mai, Thailand