UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050215 |
|---|---|
| Receipt number | R000057185 |
| Scientific Title | Investigation of Shoulder and Elbow Disorders in overhand throwing Using Ultrasound Shear Wave Elastography. |
| Date of disclosure of the study information | 2023/02/02 |
| Last modified on | 2023/02/02 10:35:48 |
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Basic information
Public title
Investigation of Shoulder and Elbow Disorders in overhand throwing Using Ultrasound Shear Wave Elastography.
Acronym
Investigation of Shoulder and Elbow Disorders in overhand throwing Using Ultrasound Shear Wave Elastography.
Scientific Title
Investigation of Shoulder and Elbow Disorders in overhand throwing Using Ultrasound Shear Wave Elastography.
Scientific Title:Acronym
Investigation of Shoulder and Elbow Disorders in overhand throwing Using Ultrasound Shear Wave Elastography.
Region
| Japan |
Condition
Condition
the disabled throwing shoulder
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to quantitatively evaluate the stiffness changes of around the shoulder muscle by overthrowing pitching using SWE and to examine whether they are related to the analysis of pitching motion.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Stiffness changes in SWE around shoulder and elbow joints after pitching
Key secondary outcomes
range of motion, functional evaluation, MRI imaging evaluation about shoulder and elbow joint
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
The examinee will throw 20 pitches.
SWE measurement and throwing motion analysis will be performed before and after pitching.
SWE will be measured using Aixplorer (Supersonic Imagine).
Throwing motion will be analyzed using motus (oneworld).
Interventions/Control_2
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
| 45 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Athletes with overthrow movements
Subjects who, after receiving a full explanation of their participation in this study and with full understanding, have given their free written consent (or that of their surrogate in the case of minors).
Key exclusion criteria
(1) Those who are extremely non-compliant
(2) Those deemed inappropriate as subjects by the principal investigator
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | yoshiaki |
| Middle name | |
| Last name | itoigawa |
Organization
Juntendo University Urayasu Hospital
Division name
Orthopaedic Surgery
Zip code
279-0021
Address
2-1-1 Tomioka, Urayasu, Chiba, Japan
TEL
047-353-3111
yitoiga@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Hironori |
| Middle name | |
| Last name | Tsurukami |
Organization
Juntendo University Urayasu Hospital
Division name
Orthopaedic Surgery
Zip code
279-0021
Address
2-1-1 Tomioka, Urayasu, Chiba, Japan
TEL
047-353-3111
Homepage URL
h-tsurukami@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
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
Juntendo University Urayasu Hospital
Address
2-1-1 Tomioka, Urayasu, Chiba, Japan
Tel
047-353-3111
h-tsurukami@juntendo.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
| 2023 | Year | 02 | Month | 02 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 04 | Month | 13 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 13 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 13 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 02 | Month | 02 | Day |
Last modified on
| 2023 | Year | 02 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057185
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
