UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000041248
Receipt No. 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 (Ver. 2)

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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
Institute Morinomiya University of Medical Sciences
Institute
Department

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047059