UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054271 |
|---|---|
| Receipt number | R000061962 |
| Scientific Title | Effect of the athlete with a bad physical condition on Low Level Laser Therapy (: LLLT) or Electrical Acupuncture Therapy (: EAT) . |
| Date of disclosure of the study information | 2024/04/26 |
| Last modified on | 2024/04/26 16:20:32 |
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Basic information
Public title
Effect of the athlete with a bad physical condition on Low Level Laser Therapy (: LLLT) or Electrical Acupuncture Therapy (: EAT) .
Acronym
Effect of the athlete with a bad physical condition on Low Level Laser Therapy (: LLLT) or Electrical Acupuncture Therapy (: EAT) .
Scientific Title
Effect of the athlete with a bad physical condition on Low Level Laser Therapy (: LLLT) or Electrical Acupuncture Therapy (: EAT) .
Scientific Title:Acronym
Effect of the athlete with a bad physical condition on Low Level Laser Therapy (: LLLT) or Electrical Acupuncture Therapy (: EAT) .
Region
| Japan |
Condition
Condition
Athelete ( men and women)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify whether LLLT (Low Level Laser Therapy) or EAT (Electrical Acupuncture Therapy) is useful for injuries and symptoms in athletes.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pain threshold: evaluated before and after LLLT or EAT with a push-pull gauge
Key secondary outcomes
Google Forms: Name, age, gender, height, weight, sport, and sports injury
Muscle stiffness: assessed before and after LLLT or EAT by ultrasound elastography
Subjective changes: evaluated by NRS before and after LLLT or EAT
Base
Study type
Interventional
Study design
Basic design
n-of-1
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
LLLT is delivered to a total of five locations around the pain area of subjective pain (irradiation time of about 1 minute).
EAT is applied at 5 Hz for 10 minutes to the area surrounding the subjective pain site.
Interventions/Control_2
The control group was evaluated only.
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
| 23 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Athletes who come to the acupuncture and moxibustion center
Athletes between the ages of 18 and 23
Subjects who consented to participate in the research
Key exclusion criteria
metal allergic person
Pacemaker Holders
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Keisaku |
| Middle name | |
| Last name | Kimura |
Organization
Niigata University of Health and Welfare
Division name
Department of Acupuncture, Moxibustion and Health
Zip code
9503198
Address
1398 Shimami-cho, Kita-ku, Niigata City, Niigata Prefecture
TEL
0252501923
keisaku-kimura@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Michiyo |
| Middle name | |
| Last name | Takano |
Organization
Niigata University of Health and Welfare
Division name
Department of Acupuncture, Moxibustion and Health
Zip code
9503198
Address
1398 Shimami-cho, Kita-ku, Niigata City, Niigata Prefecture
TEL
0252501923
Homepage URL
keisaku-kimura@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Niigata University of Health and Welfare
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
Niigata University of Health and Welfare
Address
1398 Shimami-cho, Kita-ku, Niigata City, Niigata Prefecture
Tel
0252501923
keisaku-kimura@nuhw.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 | 04 | Month | 26 | 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 | 10 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 04 | Month | 26 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 20 | 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 | 04 | Month | 26 | Day |
Last modified on
| 2024 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061962
| Research Plan | |
|---|---|
| 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 |
