UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050338 |
|---|---|
| Receipt number | R000057299 |
| Scientific Title | survey of adverse events related to acupuncture treatment among soccer trainers. |
| Date of disclosure of the study information | 2023/03/01 |
| Last modified on | 2023/02/14 17:32:33 |
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Basic information
Public title
Survey of adverse events of acupuncture treatment in soccer trainers.
Acronym
Survey on adverse events of acupuncture treatment
Scientific Title
survey of adverse events related to acupuncture treatment among soccer trainers.
Scientific Title:Acronym
Research Study on Adverse Events of Acupuncture and Moxibustion Treatment
Region
| Japan |
Condition
Condition
healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Cross-sectional survey of adverse events of acupuncture treatment and problems that interfere with athletic activities in the field of soccer.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Cross-sectional questionnaire survey
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Acupuncturists and moxibustion therapists with experience as trainers in soccer sports
Key exclusion criteria
none
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hideki |
| Middle name | |
| Last name | Fujimoto |
Organization
Tokyo Ariake University of Medical and Health Sciences
Division name
Faculty of Health Sciences Depertment of Acupuncture and Moxibustion
Zip code
135-0063
Address
2-9-1 Ariake, Koto-ku, Tokyo 135-0063 Japan
TEL
03-6703-7000
fujimoto@tau.ac.jp
Public contact
Name of contact person
| 1st name | Hideki |
| Middle name | |
| Last name | Fujimoto |
Organization
Tokyo Ariake University of Medical and Health Sciences
Division name
Faculty of Health Sciences Depertment of Acupuncture and Moxibustion
Zip code
135-0063
Address
2-9-1 Ariake, Koto-ku, Tokyo 135-0063 Japan
TEL
03-6703-7000
Homepage URL
fujimoto@tau.ac.jp
Sponsor or person
Institute
Tokyo Ariake University of Medical and Health Sciences
Institute
Department
Personal name
Funding Source
Organization
Public Interrest Incorporated Foundation for training and Licensure Examination in Anma-Massage-Acupressure,Acupuncture and Moxibustion
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Ariake University of Medical and Health Sciences Ethics commitee
Address
Tokyo Ariake University of Medical and Health Sciences
Tel
03-6703-7000
fujimoto@tau.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 | 03 | Month | 01 | Day |
Related information
URL releasing protocol
None
Publication of results
Partially published
Result
URL related to results and publications
None
Number of participants that the trial has enrolled
150
Results
57 traner(54 males and 3 females)responded(38%).The most common adverse events of acupuncture were internal bleeding in 52(91.2%),microbleeding in 42(73.7%),and pain during needling in 43(75.4%).As for adverse events of moxibustion 11(19.3%)were unintentional burns and 6 (10.5%) were suppuration of moxibustion scars.Have you ever experienced any problems in athletes' competitive activities due to acupuncture and moxibustion treatment? Yes;7(12.3%), No;45(78.9%),Don't know;5(8.8%).
Results date posted
| 2023 | Year | 02 | Month | 14 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Acupuncturists and moxibustion therapists with experience as trainers in football
Participant flow
The responses were obtained through a mailing list and a web-based questionnaire.
Adverse events
None
Outcome measures
The survey items included age, gender, number of years of clinical practice, details of adverse events caused by acupuncture and moxibustion treatment, whether or not there were any problems with athletic activities, and the athletes' impressions immediately after the acupuncture treatment.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
| 2020 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2022 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2023 | Year | 08 | Month | 01 | Day |
Other
Other related information
None
Management information
Registered date
| 2023 | Year | 02 | Month | 14 | Day |
Last modified on
| 2023 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057299
