UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058868 |
|---|---|
| Receipt number | R000067320 |
| Scientific Title | Effect of thermal stimulation using a ceramic electric moxibustion device on the athlete with a bad physical condition. |
| Date of disclosure of the study information | 2025/08/22 |
| Last modified on | 2025/08/22 15:37:50 |
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Basic information
Public title
Effect of thermal stimulation using a ceramic electric moxibustion device on the athlete with a bad physical condition.
Acronym
Effect of moxibustion using a ceramic electric moxibustion device on the athlete with a bad physical condition.
Scientific Title
Effect of thermal stimulation using a ceramic electric moxibustion device on the athlete with a bad physical condition.
Scientific Title:Acronym
Effect of thermal stimulation using a ceramic electric moxibustion device on the athlete with a bad physical condition.
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 thermal stimulation using a ceramic electric moxibustion device is useful for injuries and symptoms in athletes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pain threshold is evaluated before and after intervention using a push-pull gauge
Ease of movement is evaluated before and after intervention using VAS
Satisfaction is evaluated after intervention using a 5-point satisfaction scale
Key secondary outcomes
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
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Athletes select a comfortable temperature and stimulation method to stimulate the affected area for approximately 30 seconds. The comfortable temperature is determined by confirming which of the three temperatures of 43 degree, 46 degree, or 49 degree is most comfortable. Participants are asked to select the most comfortable stimulation method, either point or area. For point stimulation, the device is applied to the skin for 3 seconds and then immediately removed, repeated three times. For area stimulation, the device is rubbed along the skin for 3 seconds and then immediately removed, repeated three times.
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
| 24 | 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 24
Subjects who consented to participate in the research
Key exclusion criteria
Athletes with acute sports injuries
Athletes with significant swelling in the affected area
Athletes wearing braces (with the braced area being the main complaint)
Athletes with obvious neurological findings
Athletes with metal allergies
Target sample size
30
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 | keisaku |
| Middle name | |
| Last name | Kimura |
Organization
Niigata University of Health and Welfare
Division name
Department of Acupuncture and Moxibustion
Zip code
950-3198
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
Keisaku Kimura
Funding Source
Organization
Niigata University of Health and Welfare
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Niigata University of Health and Welfare
Address
Niigata University of Health and Welfare
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
新潟県
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 08 | Month | 22 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 08 | Month | 22 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 05 | Day |
Last follow-up date
| 2027 | 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
| 2025 | Year | 08 | Month | 22 | Day |
Last modified on
| 2025 | Year | 08 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067320
