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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030774
Receipt No. R000035139
Scientific Title A study of elastic measurement in medial elbow joint using ultrasound elastography
Date of disclosure of the study information 2018/01/12
Last modified on 2019/07/16

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Basic information
Public title A study of elastic measurement in medial elbow joint using ultrasound elastography
Acronym A study of elastic measurement in medial elbow joint using ultrasound elastography
Scientific Title A study of elastic measurement in medial elbow joint using ultrasound elastography
Scientific Title:Acronym A study of elastic measurement in medial elbow joint using ultrasound elastography
Region
Japan

Condition
Condition nothing
Classification by specialty
Adult Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 1)Investigation of reliability of elastic measurement in medial elbow joint using ultrasound elastography
2)Investigation of the effect of stretching and gripping for tissue elasticity of medial elbow joint
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Tissue elasticity of medial elbow joint by ultrasound elastography
Key secondary outcomes Grip strength, Circumference of forearm, Systemic joint flaccidity test

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Maneuver
Interventions/Control_1 After stretching, 2 sets of 30 seconds
Interventions/Control_2 Maximal gripping, 5 seconds
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
18 years-old <=
Age-upper limit
25 years-old >=
Gender Male and Female
Key inclusion criteria Healthy college students
Key exclusion criteria 1) Persons who have pain in the elbow joint
2) Persons who have an operation history at the elbow joint
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Hiroshi
Middle name
Last name Hattori
Organization Graduate school of Saitama Medical University
Division name Department of Medicine
Zip code 350-0436
Address 981 Kawakado, Moroyama, Saitama, Japan
TEL 049-295-1001
Email hiroshi.hattori1024@gmail.com

Public contact
Name of contact person
1st name Hiroshi
Middle name
Last name Hattori
Organization Graduate school of Saitama Medical University
Division name Department of Medicine
Zip code 350-0436
Address 981 Kawakado, Moroyama, Saitama, Japan
TEL 049-295-1001
Homepage URL
Email hiroshi.hattori1024@gmail.com

Sponsor
Institute Saitama Medical University
Institute
Department

Funding Source
Organization Saitama Medical University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Saitama Medical University
Address 1397-1 Yamane, Hidaka, Saitama, Japan
Tel 042-984-4801
Email h_rinri@saitama-med.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
2018 Year 01 Month 12 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled 29
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 Completed
Date of protocol fixation
2018 Year 01 Month 11 Day
Date of IRB
2018 Year 02 Month 08 Day
Anticipated trial start date
2018 Year 03 Month 01 Day
Last follow-up date
2019 Year 04 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
2018 Year 01 Month 11 Day
Last modified on
2019 Year 07 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035139

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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