UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057367 |
|---|---|
| Receipt number | R000065556 |
| Scientific Title | Test to improve stiff shoulders by using pillow |
| Date of disclosure of the study information | 2025/05/31 |
| Last modified on | 2025/03/23 16:41:37 |
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Basic information
Public title
Test to improve stiff shoulders by using pillow
Acronym
Test to improve stiff shoulders by using pillow
Scientific Title
Test to improve stiff shoulders by using pillow
Scientific Title:Acronym
Test to improve stiff shoulders by using pillow
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The pillow is a massage device that can be easily used when you feel stiff shoulders, etc., to obtain the effects of acupressure and stretching. Although users have reported that it has the effect of improving stiff shoulders, there are no cases where this effect has been objectively demonstrated. Therefore, in this study, we will conduct human trials using a thermography camera, muscle hardness meter, etc., with the aim of objectively verifying the pillow's effect of improving stiff shoulders.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The following indicators before and after using the pillow:
- Change in back temperature measured with a thermography camera
Key secondary outcomes
The following indices before and after using the pillow:
- Change in left and right shoulder hardness measured by muscle hardness meter
- Change in shoulder stiffness index measured by VAS
- Change in sympathetic, parasympathetic, and total power measured by autonomic nervous system meter
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Shoulder blade release pillow
Interventions/Control_2
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
| 65 | years-old | >= |
Gender
Male
Key inclusion criteria
Those whose living environment will not change significantly during the test period.
Those who can visit the designated test location on the designated test date.
Those who can wear an autonomic nervous system measurement device.
Key exclusion criteria
Those who have a medical history of treatment for malignant tumors, heart failure, or myocardial infarction.
Those who are currently undergoing treatment for or have a medical history of the following chronic diseases: arrhythmia, liver disorder, renal disorder, cerebrovascular disease, rheumatism, diabetes, dyslipidemia, hypertension, and other chronic diseases.
Those who have participated in other clinical trials within the month prior to the study period.
Those who the study director judges to be inappropriate for this study.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Motoya |
| Middle name | |
| Last name | Ikeguchi |
Organization
Okyama Prefectural University
Division name
Faculty of Health and Welfare Science
Zip code
719-1197
Address
111, Kuboki, Soja-shi, Okayama
TEL
0866942154
motoya_ikeguchi@fhw.oka-pu.ac.jp
Public contact
Name of contact person
| 1st name | Motoya |
| Middle name | |
| Last name | Ikeguchi |
Organization
Okayama Prefectural University
Division name
Faculty of Health and Welfare Science
Zip code
719-1197
Address
111, Kuboki, Soja-shi, Okayama
TEL
0866942154
Homepage URL
motoya_ikeguchi@fhw.oka-pu.ac.jp
Sponsor or person
Institute
Okayama Prefectural University
Institute
Department
Personal name
Funding Source
Organization
MEJ Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Okayama Prefectural University Ethics Committee
Address
111, Kuboki, Soja-shi, Okayama
Tel
0866942154
motoya_ikeguchi@fhw.oka-pu.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
24-81
Org. issuing International ID_1
Okayama Prefectural University Ethics Committee
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 05 | Month | 31 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 02 | Month | 17 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 18 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 19 | Day |
Last follow-up date
| 2025 | Year | 05 | 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
| 2025 | Year | 03 | Month | 23 | Day |
Last modified on
| 2025 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065556
