UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053768 |
|---|---|
| Receipt number | R000058521 |
| Scientific Title | Prediction of In-Season Groin Pain Occurrence in Male High School Soccer Players with the Copenhagen Hip And Groin Outcome Score (HAGOS): A Cohort Study |
| Date of disclosure of the study information | 2024/03/04 |
| Last modified on | 2024/03/04 09:35:18 |
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Basic information
Public title
Prediction of In-Season Groin Pain Occurrence in Male High School Soccer Players with the Copenhagen Hip And Groin Outcome Score (HAGOS): A Cohort Study
Acronym
Prediction of In-Season Groin Pain Occurrence in Male High School Soccer Players with the Copenhagen Hip And Groin Outcome Score (HAGOS): A Cohort Study
Scientific Title
Prediction of In-Season Groin Pain Occurrence in Male High School Soccer Players with the Copenhagen Hip And Groin Outcome Score (HAGOS): A Cohort Study
Scientific Title:Acronym
Prediction of In-Season Groin Pain Occurrence in Male High School Soccer Players with the Copenhagen Hip And Groin Outcome Score (HAGOS): A Cohort Study
Region
| Japan |
Condition
Condition
Groin pain
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The Japanese version of HAGOS was used to determine if the HAGOS Score during preseason could predict in-season groin pain.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pre-season HAGOS score is predictive of in-season groin pain occurrence
Key secondary outcomes
The severity of groin pain
The relationship between HAGOS scores and the classification of groin pain
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 15 | years-old | <= |
Age-upper limit
| 18 | years-old | > |
Gender
Male
Key inclusion criteria
Male high school students participating in the Japanese under 18 soccer league.
Participants must be at the level of a prefectural tournament participant or a member of the national league
Key exclusion criteria
Teams that did not receive approval.
Players unable to participate due to injury at the start of the study.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Kazuki |
| Middle name | |
| Last name | Fujisaki |
Organization
Ota Medical College of Technology
Division name
Department of Physical Therapy
Zip code
373-0812
Address
1373 Higashi Nagaoka-cho, Ota City, Gunma Prefecture
TEL
0276-25-2414
kazuki.0838@gmail.com
Public contact
Name of contact person
| 1st name | Kauzki |
| Middle name | |
| Last name | Fujisaki |
Organization
Ota Medical College of Technology
Division name
Department of Physical Therapy
Zip code
373-0812
Address
1373 Higashi Nagaoka-cho, Ota City, Gunma Prefecture
TEL
0276-25-2414
Homepage URL
kazuki.0838@gmail.com
Sponsor or person
Institute
others
Institute
Department
Personal name
Kazuki Fujisaki
Funding Source
Organization
none
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
Ota College of Medical Technical Ethics Review Committee
Address
1373 Higashi Nagaoka-cho, Ota City, Gunma Prefecture
Tel
0276-25-2414
kazuki.0838@gmail.com
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
| 2024 | Year | 03 | Month | 04 | 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
111
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
| 2022 | Year | 10 | Month | 31 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 06 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2024 | Year | 03 | Month | 04 | Day |
Last modified on
| 2024 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058521
| 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 |
