UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045887 |
|---|---|
| Receipt number | R000052385 |
| Scientific Title | Efficacy of new fabric patch (A.ATH patch) on shoulder stiffness. |
| Date of disclosure of the study information | 2021/11/01 |
| Last modified on | 2024/11/01 12:03:38 |
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Basic information
Public title
Efficacy of new fabric patch on shoulder stiffness.
Acronym
Treatment for shoulder stiffness by new fabric patch.
Scientific Title
Efficacy of new fabric patch (A.ATH patch) on shoulder stiffness.
Scientific Title:Acronym
Efficacy of new fabric patch (A.ATH patch) on shoulder stiffness.
Region
| Japan |
Condition
Condition
shoulder stiffness
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of A.ATH fabric patch on shoulder stiffness.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visual Analogue Scale (VAS) for shoulder stiffness
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
A.ATH fabric path for 24 hours
Interventions/Control_2
non-A.ATH fabric path for 24 hours
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 and Female
Key inclusion criteria
Awareness of shoulder stiffness
Key exclusion criteria
(1)The person who uses a pain-killer, muscle relaxant, a compress.
(2)Person with the pregnancy or its possibility.
(3)The person who is less than six hours for mean sleeping hours.
(4)The person who is predicted her menstruation during an intervention period.
(5)The person with chronic ache in a glenohumeral joint.
(6)The person who underwent a surgery for spine, human trunk part, or arms within three months.
(7)The person who may have rashes by contact with the fiber product.
(8)The person who is judged to be ineligible for this intervention by the doctor.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Toshihiro |
| Middle name | |
| Last name | Akisue |
Organization
Kobe University Graduate School of Health Sciences
Division name
Department of Rehabilitation Science
Zip code
6540142
Address
7-10-2 Tomoga-oka, Suma-ku, Kobe
TEL
0787964596
akisue@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Toshihiro |
| Middle name | |
| Last name | Akisue |
Organization
Kobe University Graduate School of Health Sciences
Division name
Department of Rehabilitation Science
Zip code
6540142
Address
7-10-2 Tomoga-oka, Suma-ku, Kobe
TEL
0787964596
Homepage URL
akisue@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
Funding Source
Organization
Kobe University Graduate School of Health Sciences
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
Institutional Review Board, Kobe University Graduate School of Health Sciences
Address
7-10-2 Tomoga-oka, Suma-ku, Kobe
Tel
0787964502
syomu2@ams.kobe-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
| 2021 | 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
Terminated
Date of protocol fixation
| 2021 | Year | 06 | Month | 15 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 12 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2023 | 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
| 2021 | Year | 10 | Month | 27 | Day |
Last modified on
| 2024 | Year | 11 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052385
