UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054171 |
|---|---|
| Receipt number | R000061860 |
| Scientific Title | Effect of Electroacupuncture on Delayed-Onset Muscle Soreness Induced by Eccentric Exercise |
| Date of disclosure of the study information | 2024/04/17 |
| Last modified on | 2024/04/17 01:55:43 |
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Basic information
Public title
Effect of Electroacupuncture on Delayed-Onset Muscle Soreness Induced by Eccentric Exercise
Acronym
Effect of Electroacupuncture on Muscle Pain and Muscle Damage
Scientific Title
Effect of Electroacupuncture on Delayed-Onset Muscle Soreness Induced by Eccentric Exercise
Scientific Title:Acronym
Effect of Electroacupuncture on DOMS Induced by Eccentric Exercise
Region
| Japan |
Condition
Condition
Exercise-Induced Muscle Pain and Muscle Damage
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To analyze whether electroacupuncture suppresses delayed onset muscle soreness.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Muscle pain up to four days after exercise load, measured by Visual Analog Scale (VAS).
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Electroacupuncture stimulation (1Hz, 15 min) to the biceps brachii that does not induce muscle pain.
Interventions/Control_2
Electroacupuncture stimulation (1Hz, 15 min) to the biceps brachii that induce muscle pain.
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
| 30 | years-old | > |
Gender
Male
Key inclusion criteria
Individuals without a habit of exercising, non-smokers, and those who have not taken any medications within three months prior to the experiment.
Key exclusion criteria
(i) massaging their upper arm, (ii) strenuous exercise, (iii) alcohol consumption, (iv) taking medication, (v) taking supplements, and (vi) receiving acupuncture or electroacupuncture treatment during the experiment
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Komine |
| Middle name | |
| Last name | Shoichi |
Organization
Teikyo Heisei University
Division name
Faculty of Human Health, Department of Acupuncture and Moxibustion
Zip code
170-8445
Address
2-51-4, Higashi-Ikebukuro, Toshima-ku, Tokyo
TEL
03-5843-4860
s.komine@thu.ac.jp
Public contact
Name of contact person
| 1st name | Shoichi |
| Middle name | |
| Last name | Komine |
Organization
Teikyo Heisei University
Division name
Faculty of Human Health, Department of Acupuncture and Moxibustion
Zip code
170-8445
Address
2-51-4, Higashi-Ikebukuro, Toshima-ku, Tokyo
TEL
03-5843-4860
Homepage URL
s.komine@thu.ac.jp
Sponsor or person
Institute
Teikyo Heisei University
Institute
Department
Personal name
Funding Source
Organization
Teikyo Heisei 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
Teikyo Heisei University
Address
2-51-4, Higashi-Ikebukuro, Toshima-ku, Tokyo
Tel
03-5843-4860
s.komine@thu.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 | 17 | 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
19
Results
Palpation pain was significantly lower in the IEA group than the CEA group at 72 and 96 hours after exercise. The decrease in the elbow range of motion after exercise was significantly suppressed by electroacupuncture stimulation. The muscle injury markers (creatine kinase, lactate dehydrogenase) increased following exercise, but these changes were not significantly influenced by IEA stimulation. IEA suppressed exercise-induced oxidative stress at 72 hours after exercise.
Results date posted
| 2024 | Year | 04 | Month | 17 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Due to delays in result analysis, the preparation for submission was postponed.
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
Completed
Date of protocol fixation
| 2018 | Year | 01 | Month | 05 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 27 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 05 | Day |
Last follow-up date
| 2022 | Year | 07 | Month | 01 | 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 | 17 | Day |
Last modified on
| 2024 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061860
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| Registered date | File name |
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