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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000034548
Receipt No. R000039383
Scientific Title Effects of combination approach oflow-intensity muscle contraction exercise and thermotherapy on pain sensitivity and muscle strength
Date of disclosure of the study information 2018/10/17
Last modified on 2021/04/19

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Basic information
Public title Effects of combination approach oflow-intensity muscle contraction exercise and thermotherapy on pain sensitivity and muscle strength
Acronym Effects of combination approach oflow-intensity muscle contraction exercise and thermotherapy on pain sensitivity and muscle strength
Scientific Title Effects of combination approach oflow-intensity muscle contraction exercise and thermotherapy on pain sensitivity and muscle strength
Scientific Title:Acronym Effects of combination approach oflow-intensity muscle contraction exercise and thermotherapy on pain sensitivity and muscle strength
Region
Japan

Condition
Condition Normal Adult
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to examine the effect of combination of low-intensity muscle contraction exercise and thermothrapy on pain sensitivity and muscle strength.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Pressure pain threshold of quadriceps femoris
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 low-intensity muscle contraction exercise and thermotherapy
Interventions/Control_2 low-intensity muscle contraction exercise
Interventions/Control_3 thermotherapy
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
20 years-old <=
Age-upper limit
35 years-old >=
Gender Male and Female
Key inclusion criteria Healthy adults from 20 to 35 years old
Key exclusion criteria Obvious inflammatory symptoms, Malignant tumors, Sensory disorders, Infectious disease, Peripheral circulatory disorder, there is a moderate to high intensity exercise habit of more than twice a week.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Junya
Middle name
Last name Sakamoto
Organization Nagasaki University Institute of Biomedical Sciences
Division name Health Sciences
Zip code 852-8520
Address 1-7-1, Sakamoto, Nagasaki
TEL 095-819-7964
Email jun-saka@nagasaki-u.ac.jp

Public contact
Name of contact person
1st name Junya
Middle name
Last name Sakamoto
Organization Nagasaki University Institute of Biomedical Sciences
Division name Health Sciences
Zip code 8528520
Address 1-7-1, Sakamoto, Nagasaki
TEL 095-819-7964
Homepage URL
Email jun-saka@nagasaki-u.ac.jp

Sponsor
Institute Nagasaki University
Institute
Department

Funding Source
Organization no
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 Graduate School of Biomedical Sciences, Health Science Courses, Ethics Committee.
Address 1-7-1,, Sakamoto, Nagasaki
Tel 095-819-7198
Email yoshi-t@nagasaki-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
2018 Year 10 Month 17 Day

Related information
URL releasing protocol http://www2.am.nagasaki-u.ac.jp/physical/2018/ARGH14-08.pdf
Publication of results Unpublished

Result
URL related to results and publications http://www2.am.nagasaki-u.ac.jp/physical/2018/ARGH14-08.pdf
Number of participants that the trial has enrolled 28
Results There was no significant difference among the three groups in any index throughout the experimental period, but the pressure pain threshold of the quadriceps femoris muscle significantly increased after 2 weeks from the start of the experiment compared with before the start of the experiment. And, Temporal summation of the pain tended to decline in comparison with before the experiment start.
Results date posted
2021 Year 04 Month 19 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 28 healthy adults from Nagasaki University School of Medicine
Participant flow The participant's intention to participate in the study was confirmed after fully explaining that even if the participant declined to participate in the study in order to prevent the subject from being forced to participate in the study, he or she would not suffer any disadvantages in the course of study.
Adverse events none
Outcome measures Knee extensor strength, quadriceps tenderness threshold, Temporal summation of pain, condition pain modulation
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2018 Year 10 Month 17 Day
Date of IRB
2018 Year 10 Month 11 Day
Anticipated trial start date
2018 Year 10 Month 17 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
2021 Year 03 Month 31 Day
Date trial data considered complete
2021 Year 03 Month 31 Day
Date analysis concluded
2021 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2018 Year 10 Month 17 Day
Last modified on
2021 Year 04 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039383

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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