UMIN-CTR Clinical Trial

Basic information
Public title	Press needle for aspiration pneumonia prevention in older adults: study protocol for a randomized double-blind placebo-controlled trial
Acronym	Press needle for aspiration pneumonia prevention in older adults: study protocol for a randomized double-blind placebo-controlled trial
Scientific Title	Press needle for aspiration pneumonia prevention in older adults: study protocol for a randomized double-blind placebo-controlled trial
Scientific Title:Acronym	Press needle for aspiration pneumonia prevention in older adults: study protocol for a randomized double-blind placebo-controlled trial
Region	Japan

Condition
Condition	aspiration pneumonia
Classification by specialty	Geriatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Investigation about the aspiration pneumonitis protective effect of the press tack needle stimulation for patients with cerebrovascular disorder sequelae with a history of the aspiration pneumonitis.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Number of occurrence of aspiration pneumonitis during study period
Key secondary outcomes	Latent time of swallowing reflex Substance P concentrations in saliva Mini Mental State Examination Barthel Index Body mass index Examination of drawing blood The number of fever during study period

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	PYONEX ZERO A period of the intervention: one year Quantity of the intervention: two places (four places in total) of ST-36 (anterior surface of lag), KI-3 (the rear of the malleolus medialis) The number of times of the intervention: continuation pasting (we put it twice a week and change it)
Interventions/Control_2	Sham PYONEX ZERO A period of the intervention: one year Quantity of the intervention: two places (four places in total) of ST-36 (anterior surface of lag), KI-3 (the rear of the malleolus medialis) The number of times of the intervention: continuation pasting (we put it twice a week and change it)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	65 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	The in and out patients in the collaborative investigation institution. The patients who receive at-home medical care in the collaborative investigation institution.
Key exclusion criteria	The patients with the serious disease that can produce pneumonia with chronic respiratory disease, malignant tumor, chronic ischemic disease. The patients that oral cannot take a therapeutic drug. The patients with the allergy to metal. The patients with severe skin reaction. The patients whom a deglutition reflex does not occur in at initial LTSR measurement. The patients whom aspiration pneumonitis develops in with serious case that is more than three times during the past three months.
Target sample size	140

Research contact person
Name of lead principal investigator	1st name Kaneko Middle name Last name Soichiro
Organization	Tohoku University Hospital
Division name	Department of Education and Support for Regional Medicine, Department of Kampo Medicine
Zip code	9808574
Address	1-1, Seiryo-machi, Aoba ward, Sendai 980-8574, Japan
TEL	022-717-7507
Email	souichi0134@gmail.com

Public contact
Name of contact person	1st name Kaneko Middle name Last name Soichiro
Organization	Tohoku University Hospital
Division name	Department of Education and Support for Regional Medicine, Department of Kampo Medicine
Zip code	9808574
Address	1-1, Seiryo-machi, Aoba ward, Sendai 980-8574, Japan
TEL	022-717-7507
Homepage URL
Email	souichi0134@gmail.com

Sponsor
Institute	Tohoku University Hospital Department of Education and Support for Regional Medicine, Department of Kampo Medicine
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethics Committee Tohoku University Hospital
Address	1-1, Seiryo-machi, Aoba ward, Sendai 980-8574, Japan.
Tel	022-728-4105
Email	ec@rinri.hosp.tohoku.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2016 Year 07 Month 12 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 07 Month 19 Day
Date of IRB	2016 Year 06 Month 27 Day
Anticipated trial start date	2021 Year 02 Month 01 Day
Last follow-up date	2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 07 Month 11 Day
Last modified on	2022 Year 10 Month 13 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026460