BPPV With CRP: Single Versus Multiple Cycles

Benign Paroxysmal Positional Vertigo (BPPV) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02701218
• Other study ID #: ENT-2558-03601
• Status: Recruiting
• Phase: N/A
• Start date: February 2016
• Est. completion date: December 2019

Study information

• Verified date: July 2019
• Source: Chiang Mai University
• Contact: Suwicha I Kaewsiri, MD
• Phone: 66-816802036
• Email: suwicha.kaewsiri[@]cmu.ac.th
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 114
• Est. completion date: December 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Benign Paroxysmal Positional Vertigo
• Benign Paroxysmal Positional Vertigo (BPPV)
• Dizziness
• Vertigo

Intervention

Procedure:
• Canalith repositioning procedure
Canalith repositioning procedure; single or multiple cycles

Locations

Country	Name	City	State
Thailand	Department of Otolaryngology Faculty of Medicine, Chiang Mai University 110 Intawaroros Road, Sriphum	Chiang Mai

Sponsors (1)

Lead Sponsor	Collaborator
Chiang Mai University

Country where clinical trial is conducted

Thailand, 

References & Publications (1)

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 Sur — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dix-Hallpike test (DHT)	percentage of negative DHT between single and multiple cycles	At 7th day
Secondary	Dizziness handicap inventory (DHI)	total score in the questionaire	compare to the first visit at 7th between single and multiple cycles
Secondary	Dizziness handicap inventory (DHI)	total score in the questionaire	compare to the first visit at 28th day between single and multiple cycles
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Dix-Hallpike test (DHT)	percentage of negative DHT between single and multiple cycles	At 28th day