UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034548 |
|---|---|
| Receipt number | 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 19:10:09 |
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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
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
jun-saka@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039383
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