UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054426 |
|---|---|
| Receipt number | R000060896 |
| Scientific Title | Verification of the Effect of Acupuncture Stimulation on Muscle Fatigue - Using Changes in Muscle Tissue Imaging Over Time as Indicators |
| Date of disclosure of the study information | 2024/05/20 |
| Last modified on | 2024/05/19 20:41:48 |
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Basic information
Public title
Verification of the Effect of Acupuncture Stimulation on Muscle Fatigue - Using Changes in Muscle Tissue Imaging Over Time as Indicators
Acronym
Verification of the Effect of Acupuncture Stimulation on Muscle Fatigue - Using Changes in Muscle Tissue Imaging Over Time as Indicators
Scientific Title
Verification of the Effect of Acupuncture Stimulation on Muscle Fatigue - Using Changes in Muscle Tissue Imaging Over Time as Indicators
Scientific Title:Acronym
Verification of the Effect of Acupuncture Stimulation on Muscle Fatigue - Using Changes in Muscle Tissue Imaging Over Time as Indicators
Region
| Japan |
Condition
Condition
Muscle Fatigue
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Improving muscle fatigue in athletes is an important issue. In addition, more than 70% of qualified trainers in top sports such as the J-League (soccer) and Top League (rubby) are acupuncturists, and it is common for athletes to receive acupuncture treatment for muscle fatigue. However, the effects of acupuncture on muscle fatigue and muscle tissue itself are not clear. Therefore, the purpose of this study is to clarify the effects of acupuncture stimulation on muscle fatigue and muscle tissue.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Magnetic Resonance Imaging (MRI) findings
Key secondary outcomes
Subjective degree of fatigue in the thighs (RPE: rating of perceived exertion),
Stretching pain in the quadriceps and hamstrings (VAS: Visual Analogue Scale)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Acupuncture in the medial and lateral vastus muscles
Interventions/Control_2
Control
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
Key inclusion criteria
1)Generally healthy adult males without evident organic diseases based on health examinations, who regularly engage in sports or physical activities at moderate or higher intensity.
2)Individuals who agree that they will not be compensated for any events related to this study.
3)Individuals who do not have any contraindications for MRI.
Key exclusion criteria
Individuals who did not give consent for the study
Target sample size
26
Research contact person
Name of lead principal investigator
| 1st name | NARUTO |
| Middle name | |
| Last name | YOSHIDA |
Organization
Rikkyo University
Division name
College of Sport and Wellness
Zip code
352-8558
Address
1-2-26 Kitano, Niizashi, Saitama,
TEL
048-471-7549
naruto-y-ad@rikkyo.ac.jp
Public contact
Name of contact person
| 1st name | NARUTO |
| Middle name | |
| Last name | YOSHIDA |
Organization
Rikkyo University
Division name
College of Sport and Wellness
Zip code
352-8558
Address
1-2-26 Kitano, Niizashi, Saitama
TEL
048-471-7549
Homepage URL
naruto-y-ad@rikkyo.ac.jp
Sponsor or person
Institute
Rikkyo University
Institute
Department
Personal name
Funding Source
Organization
Rikkyo 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
Rikkyo University
Address
1-2-26 Kitano, Niizashi, Saitama
Tel
048-471-7549
naruto-y-ad@rikkyo.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
| 2024 | Year | 05 | Month | 20 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 10 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 20 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 05 | Month | 18 | Day |
Last modified on
| 2024 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060896
