UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034079 |
|---|---|
| Receipt number | R000038851 |
| Scientific Title | The assessment of the stress reduction effect using shoulder muscle hardness meter |
| Date of disclosure of the study information | 2018/11/01 |
| Last modified on | 2023/04/14 14:58:34 |
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Basic information
Public title
The assessment of the stress reduction effect using shoulder muscle hardness meter
Acronym
The assessment of the stress reduction effect using shoulder muscle hardness meter
Scientific Title
The assessment of the stress reduction effect using shoulder muscle hardness meter
Scientific Title:Acronym
The assessment of the stress reduction effect using shoulder muscle hardness meter
Region
| Japan |
Condition
Condition
Healthy men and women
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study the effectiveness of evaluating the stress reduction effect using shoulder muscle hardness meter
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Heart rate
HF component
LF/HF component
Pulse wave
Hardness of shoulder muscle
Thermography
Healing scale
Japanese perceived stress score
Stiffness questionnaire
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Maneuver | Other |
Interventions/Control_1
Exercise
for one hour
Interventions/Control_2
Massage
for one hour
Interventions/Control_3
Okada Purifying Therapy
for one hour
Interventions/Control_4
rest on a bed
for one hour
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
| 74 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy men and women
Key exclusion criteria
Persons with disease
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Seiya |
| Middle name | |
| Last name | Uchida |
Organization
MOA Health Science Foundation
Division name
Research Department
Zip code
413-0038
Address
1-1-60 Nishiatami, Atami-shi, Shizuoka
TEL
+81-557-86-0663
seiya-u@mhs.or.jp
Public contact
Name of contact person
| 1st name | Seiya |
| Middle name | |
| Last name | Uchida |
Organization
MOA Health Science Foundation
Division name
Research Department
Zip code
413-0038
Address
4-8-10, Takanawa, MInato-ku, Tokyo
TEL
+81-3-5421-7030
Homepage URL
seiya-u@mhs.or.jp
Sponsor or person
Institute
MOA Health Science Foundation
Institute
Department
Personal name
Funding Source
Organization
MOA Health Science Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
MOA Health Science Foundation
Address
4-8-10, Takanawa, MInato-ku, Tokyo
Tel
+81-3-5421-7030
seiya-u@mhs.or.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 | 11 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 13 | Day |
Anticipated trial start date
| 2018 | Year | 11 | 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
| 2018 | Year | 09 | Month | 10 | Day |
Last modified on
| 2023 | Year | 04 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038851
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
