UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041248
Receipt number R000047059
Scientific Title Comparison of circular skin acupuncture and pushing stimulation for pedal edema
Date of disclosure of the study information 2020/07/29
Last modified on 2020/09/04 13:19:41

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Basic information

Public title

Comparison of circular skin acupuncture and pushing stimulation for pedal edema

Acronym

Comparison of circular skin acupuncture and pushing stimulation for pedal edema

Scientific Title

Comparison of circular skin acupuncture and pushing stimulation for pedal edema

Scientific Title:Acronym

Comparison of circular skin acupuncture and pushing stimulation for pedal edema

Region

Japan


Condition

Condition

The female who take cognizance of pedal edem a

Classification by specialty

Medicine in general Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

we compared circular skin acupuncture and pushing stimulation using the scale.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

the edema scale

Key secondary outcomes

Visual Analog Scale (VAS), examined the 9-cm circumference at the malleolus medialis (ankle circumference)


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Acupuncture group: circular skin acupuncture 0.17mm * 0.9mm, once/2 days; total thrice

Interventions/Control_2

pushing group: pushing stimulation 0.17mm * 0.3mm(non-invasive treatment), once/2 days; total thrice

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10

20


Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

60 years-old >=

Gender

Female

Key inclusion criteria

(1) female aged 20-60, (2) The female who take cognizance of pedal edema, (3)Those who can participate in the research schedule.

Key exclusion criteria

(1) Those who are pregnant or breastfeeding, (2 No history of contact dermatitis due to an adhesive tape.

Target sample size

104


Research contact person

Name of lead principal investigator

1st name ryouta
Middle name
Last name tsuji

Organization

Morinomiya University of Medical Sciences

Division name

Department of acupuncture and moxibustion,Faculty of Health Sciences

Zip code

559-8611

Address

1-26-16, nankoukita suminoeku oosaka city, Osaka prefecture, 559-8611

TEL

+81-6-6616-6911

Email

tsuji@morinomiya-u.ac.jp


Public contact

Name of contact person

1st name hiroshi
Middle name
Last name kuge

Organization

Osaka Medical College Hospital

Division name

Department of Anesthesiology and pain clinic

Zip code

569-8686

Address

2-7, daigakumachi Takatsuki city, Osaka prefecture, 569-8686

TEL

+81-90-1487-1151

Homepage URL


Email

sherry@kha.biglobe.ne.jp


Sponsor or person

Institute

Morinomiya University of Medical Sciences

Institute

Department

Personal name



Funding Source

Organization

Morinomiya University of Medical Sciences

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Morinomiya University of Medical Sciences


Other related organizations

Co-sponsor

Department of Acupuncture, Morinomiya College of Medical Arts and Sciences

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Morinomiya University of Medical Sciences

Address

1-26-16, nankoukita suminoeku oosaka city, Osaka prefecture, 559-8611

Tel

+81-6-6616-6911

Email

tsuji@morinomiya-u.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

森ノ宮医療学園専門学校(大阪府)


Institutions

Institutions

Morinomiya College of Medical Arts and Sciences (oosaka prefecture)


Other administrative information

Date of disclosure of the study information

2020 Year 07 Month 29 Day


Related information

URL releasing protocol

https://upload.umin.ac.jp/cgi-bin/fileshare/upload.cgi

Publication of results

Unpublished


Result

URL related to results and publications

https://upload.umin.ac.jp/cgi-bin/fileshare/upload.cgi

Number of participants that the trial has enrolled

20

Results

Circular skin acupuncture and pushing stimulation for pedal edema showed no differences in the conscious state.

Results date posted

2020 Year 07 Month 26 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

We extracted items from the activities of daily living that are related to pedal edema and created a scale for the assessment of pedal edema.

Participant flow

The numbers randomly assigned, the numbers used for outcome analysis, and the numbers used for statistical analysis were the same as those at the start of the study.

Adverse events

There were no unintended effects (adverse events).

Outcome measures

The edema scale, Visual Analog Scale (VAS), examined the 9-cm circumference at the malleolus medialis (ankle circumference)

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2017 Year 05 Month 01 Day

Date of IRB

2017 Year 06 Month 30 Day

Anticipated trial start date

2018 Year 02 Month 01 Day

Last follow-up date

2018 Year 12 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 07 Month 29 Day

Last modified on

2020 Year 09 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047059


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name