UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051207 |
|---|---|
| Receipt number | R000058405 |
| Scientific Title | Analysis of Muscle Hardness Using Ultrasonic Elastography and the Effect of Electro-Acupuncture |
| Date of disclosure of the study information | 2023/05/31 |
| Last modified on | 2024/05/31 09:14:11 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Analysis of Muscle Hardness Using Ultrasonic Elastography and the Effect of Electro-Acupuncture
Acronym
Evaluation of Muscle Stiffness Using Ultrasonic Elastography and the Effect of Acupuncture
Scientific Title
Analysis of Muscle Hardness Using Ultrasonic Elastography and the Effect of Electro-Acupuncture
Scientific Title:Acronym
Evaluation of Muscle Stiffness Using Ultrasonic Elastography and the Effect of Acupuncture
Region
| Japan |
Condition
Condition
none
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether electro-acupuncture accelerates the recovery of muscle hardness after exercise loading.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Electro-Acupuncture accelerates the recovery of muscle stiffness after exercise.
The primary outcome is the SR value of ultrasound elastography.
Key secondary outcomes
The secondary outcome is the subject's fatigue sensation assessed using VAS.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Electro-acupuncture
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
| 40 | years-old | > |
Gender
Male
Key inclusion criteria
Healthy subjects with no history of muscle injury or tendon rupture without exercise habits
Key exclusion criteria
Those with a history of fracture or muscle injury
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Kenichi |
| Middle name | |
| Last name | Kimura |
Organization
Kansai University of Health Sciences
Division name
Department of Health Sciences
Zip code
590-0482
Address
2-11-1,Walaba, Kumatori, Osaka
TEL
0724-53-8251
k.kimura@kansai.ac.jp
Public contact
Name of contact person
| 1st name | Kimura |
| Middle name | |
| Last name | Kenichi |
Organization
Kansai University of Health Sciences
Division name
Department of Health Sciences
Zip code
590-0482
Address
2-11-1,Walaba, Kumatori, Osaka
TEL
0724-53-8251
Homepage URL
k.kimura@kansai.ac.jp
Sponsor or person
Institute
Kansai University of Health Sciences
Institute
Department
Personal name
Funding Source
Organization
Kansai University of Health Sciences
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
Ethical committee of Kansai University of Heath sciences
Address
2-11-1, Wakaba, Kumatori, Osaka
Tel
0724-53-8251
t.yoshida@kansai.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 | 05 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
DOI: 10.1089/acu.2024.0018 Medical acupuncture 36,2024
Number of participants that the trial has enrolled
21
Results
In Experiment 1, SR increased significantly after exercise. There was no significant difference after 15 and 30 minutes compared to after exercise. In Experiment 2, SR was significantly lower after electro-acupuncture than after exercise and remained lower after 15 minutes of electro-acupuncture. The results suggest that electro-acupuncture to the gastrocnemius muscle may promote the recovery of gastrocnemius muscle hardness induced by calf raise exercise.
Results date posted
| 2024 | Year | 05 | Month | 31 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
No adverse events were observed.
Outcome measures
Strain ratio
Visual analogue scale
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 04 | Month | 10 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 22 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2024 | 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
| 2023 | Year | 05 | Month | 31 | Day |
Last modified on
| 2024 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058405
