臨床研究等提出・公開システム

Japanese

Date of registration	Jan. 10, 2024
Last modified on	Jan. 10, 2024
Trial ID	jRCT1071230105

Scientific Title	A new canalith repositioning procedure (parietal position method) for posterior canal short-arm type of benign paroxysmal positional vertigo (A new CRP (parietal position method) for PC short-arm type of BPPV)
Public Title	A new canalith repositioning procedure for posterior canal short-arm type of benign paroxysmal positional vertigo (A new CRP for PC short-arm type of BPPV)

Contact for Scientific Queries	Name	Shigeno Kohichiro
	Affiliation	SHIGENO OTOLARYNGOLOGY VERTIGO-HEARING IMPAIRMENT CLINIC
	Address	1-21 Ougimati, Nagasaki, 852-8132, Japan
	Telephone	+81-95-844-1848
	E-mail	mail@shigeno.info
Contact for Public Queries	Name	Shigeno Kohichiro
	Affiliation	SHIGENO OTOLARYNGOLOGY VERTIGO-HEARING IMPAIRMENT CLINIC
	Address	1-21 Ougimati, Nagasaki, 852-8132, Japan
	Telephone	+81-95-844-1848
	E-mail	mail@shigeno.info

Recruitment status	Recruiting

Anticipated date of first enrollment		Jan. 10, 2024
Actual date of first enrollment
Target sample size		60
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	active control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1. Adults over 18 years old 2. Patients with posterior canal BPPV (short-arm type)
	Exclusion Criteria	1. Patients with chronic headache, neck pain, or lower back pain 2. Patients with a history of cervical or lumbar spine disease, heart disease, Meniere disease or central disease 3. Patients suspected of having retinal disease such as retinal detachment
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender
Health Condition(s) or Problem(s) Studied		Some subjects may experience neck pain or stiff shoulders due to parietal position method.
Intervention(s)		Patients with posterior canal BPPV (short-arm type) will be randomly assigned to two groups: one group performes the parietal position method and takes anti-vertigo medication (3 tablets of betahistine mesylate tablets, 6 mg, three times a day, after each meal, for 3 days), and the other group takes anti-vertigo medication alone. The disappearance of positional nystagmus on the day after the test will be compared between these two groups.
Health Condition(s) Keyword		BPPV Posterior semiciecular canal Short-arm
Intervention(s) Keyword		Otolith repositioning procedure Posterior semicircular canal Short-arm
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Disappearance of positional nystagmus on the day after the test
Secondary Outcome(s)		Reduction of perceived intensity of positional vertigo (Visual analogue scale)

Primary Sponsor	Shigeno Kohichiro

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Nagasaki University Hospital Clinical Research Ethics Committee
Address	1-7-1 Sakamoto, Nagasaki, 852^-8501, Japan, Nagasaki
Telephone	+81-95-819-7229
E-Mail	gaibushikin@ml.nagasaki-u.ac.jp
Approval Status	Approval
Date of approval	Dec. 18, 2023

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none