Clinical trial NCT02701218: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Benign Paroxysmal Positional Vertigo (BPPV)
Keywords: Canalith repositioning procedure (CRP)
BPPV
Lead sponsor: Chiang Mai University
Sponsor class: OTHER
First posted: 2016-03-08
Enrollment: 114
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Dix-Hallpike test (DHT)
timeFrame: At 7th day
Secondary outcomes:
measure: Dizziness handicap inventory (DHI)
timeFrame: compare to the first visit at 7th between single and multiple cycles
measure: Dizziness handicap inventory (DHI)
timeFrame: compare to the first visit at 28th day between single and multiple cycles
measure: Subjective symptoms
timeFrame: Improvement of the symptoms compare to the first visit at 7th day between single and multiple cycles
measure: Subjective symptoms
timeFrame: Improvement of the symptoms compare to the first visit at 28th day between single and multiple cycles
measure: Loss of balance
timeFrame: compare to the first visit at 7th between single and multiple cycles
measure: Loss of balance
timeFrame: compare to the first visit at 28th day between single and multiple cycles
measure: Dix-Hallpike test (DHT)
timeFrame: At 28th day
Other outcomes:
Locations:
city: Chiang Mai
country: Thailand
facility: Department of Otolaryngology Faculty of Medicine, Chiang Mai University 110 Intawaroros Road, Sriphum
Study officials:
affiliation: Department of Otolaryngology
name: Suwicha I Kaewsiri, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.