UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063581 |
|---|---|
| Receipt number | R000072760 |
| Scientific Title | Efficacy of Physical Therapy Modalities for Muscle Fatigue and Delayed Onset Muscle Soreness |
| Date of disclosure of the study information | 2026/11/11 |
| Last modified on | 2026/11/10 14:25:50 |
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Basic information
Public title
A Study on the Effects of Physical Therapy Modalities on Muscle Fatigue and Muscle Soreness
Acronym
Effects of Physical Therapy Modalities on Muscle Fatigue and Soreness
Scientific Title
Efficacy of Physical Therapy Modalities for Muscle Fatigue and Delayed Onset Muscle Soreness
Scientific Title:Acronym
Physical Therapy Modalities for Muscle Fatigue and DOMS
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In Japan, efforts are being focused on promoting health to ensure the stability of the social security system. The Health Promotion Act was enacted in 2002, and the Ministry of Health, Labour and Welfare is promoting the "Second National Health Promotion Campaign for the 21st Century." The basic direction of this campaign places emphasis on establishing regular exercise habits. According to the results of the 2014 Physical Fitness and Motor Ability Survey released by the Japan Sports Agency, an upward trend was observed among both adolescents (ages 6-19) and older adults (ages 65-79), indicating that results are gradually becoming apparent.
Amid these efforts to promote exercise habits, muscle fatigue and delayed-onset muscle soreness (DOMS) are often induced. These conditions are caused by excessive muscle use, unfamiliar exercises, or lengthening contractions. Physiologically, muscle fatigue is a state in which muscle tension during contraction decreases abruptly (Katayama, N., et al., 1994). On the other hand, delayed-onset muscle soreness is characterized by persistent muscle pain and stiffness lasting 1 to 5 days after exercise (Armstrong, 1984; Cleak and Eston, 1992; Hirose et al., 2004; Seta et al., 2008). These symptoms are thought to act as barriers to establishing a regular exercise routine, and measures to address them are therefore necessary.
Previous studies have shown that physical therapy modalities such as heat therapy, cold therapy, and transcutaneous electrical nerve stimulation (TENS) are effective for muscle fatigue and delayed-onset muscle soreness (Utsunomiya et al., 2009; Yuasa et al., 2012; Mayer et al., 2006; Petrofsky et al., 2013; Denegar and Perrin, 1992). However, to date, there has been no thorough comparative evaluation of the efficacy of these physical therapy modalities.
Therefore, the purpose of this study is to identify the optimal physical therapy modality for muscle fatigue and delayed-onset muscle soreness.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Number of elbow flexion and extension repetitions
Grip strength
Visual Analog Scale (VAS)
Muscle tenderness threshold
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Sham Treatment
Interventions/Control_2
Heat Therapy
Duration: 10 minutes
Frequency: Once
Interventions/Control_3
Cold Therapy
Duration: 10 minutes
Frequency: Once
Interventions/Control_4
Transcutaneous Electrical Nerve Stimulation
Duration: 10 minutes
Frequency: Once
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Participants must be able-bodied individuals aged 18 or older who, after receiving an oral and written explanation of the purpose and methods of the study, as well as the risks and lack of compensation associated with participation, have provided written consent indicating their voluntary participation.
Key exclusion criteria
Individuals who report severe pain that interferes with daily life, those with typical physical disabilities caused by conditions such as cerebrovascular disorders or rheumatoid arthritis, and those with a history of fractures or other conditions in the upper extremities resulting in joint fusion are excluded.
Individuals with pacemakers or other implantable medical devices, pregnant women, and those with a history of epilepsy are excluded from percutaneous electrical stimulation.
Target sample size
72
Research contact person
Name of lead principal investigator
| 1st name | Kenichiro |
| Middle name | |
| Last name | Miyahara |
Organization
Hokuriku University
Division name
Faculty of health and medical sciences
Zip code
9201180
Address
1-1 Taiyogaoka, Kanazawa
TEL
0762291161
k-miyahara@hokuriku-u.ac.jp
Public contact
Name of contact person
| 1st name | Kenichiro |
| Middle name | |
| Last name | Miyahara |
Organization
Hokuriku University
Division name
Faculty of health and medical sciences
Zip code
9201180
Address
1-1 Taiyogaoka, Kanazawa
TEL
0762291161
Homepage URL
k-miyahara@hokuriku-u.ac.jp
Sponsor or person
Institute
Hokuriku University
Institute
Department
Personal name
Funding Source
Organization
Hokuriku University
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
Hokuriku University
Address
1-1 Taiyogaoka, Kanazawa
Tel
0762291161
k-miyahara@hokuriku-u.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
| 2026 | Year | 11 | Month | 11 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 12 | Month | 25 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 25 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 25 | 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
| 2026 | Year | 11 | Month | 10 | Day |
Last modified on
| 2026 | Year | 11 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072760
