UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061216 |
|---|---|
| Receipt number | R000070045 |
| Scientific Title | The effects of arteriovenous anastomosis vascular cooling on body surface temperature and performance of the shoulder and elbow joints. |
| Date of disclosure of the study information | 2026/07/01 |
| Last modified on | 2026/04/09 19:33:39 |
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Basic information
Public title
The effects of arteriovenous anastomosis vascular cooling on body surface temperature and performance of the shoulder and elbow joints.
Acronym
The effects of arteriovenous anastomosis vascular cooling on body surface temperature and performance of the shoulder and elbow joints.
Scientific Title
The effects of arteriovenous anastomosis vascular cooling on body surface temperature and performance of the shoulder and elbow joints.
Scientific Title:Acronym
The effects of arteriovenous anastomosis vascular cooling on body surface temperature and performance of the shoulder and elbow joints.
Region
| Japan |
Condition
Condition
To develop the effective Cryotherapy
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop the effective Cryotherapy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Skin surface temperature, deep ear temperature and perfusion index, range of motion and muscle strength of the shoulder and elbow joints
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Local cooling using an ice pack
Interventions/Control_2
Cold water immersion of the Arteriovenous anastomoses
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
| 30 | years-old | >= |
Gender
Male
Key inclusion criteria
Individuals with no history of shoulder or elbow surgery, no shoulder or elbow pain or upper limb muscle pain at the time of measurement, and no cold allergy.
Key exclusion criteria
Individuals with a history of shoulder or elbow surgery, those experiencing shoulder or elbow pain or upper limb muscle pain during measurement, or those with cold allergies.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Kasahara |
Organization
Hokkaido University
Division name
Department of Rehabilitation Science, Faculty of Health Sciences
Zip code
060-0812
Address
Kita 12 Nishi 5, Kita-Ku, Sapporo, Hokkaido, Japan
TEL
011-706-3390
kasahara@hs.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Kasahara |
Organization
Hokkaido University
Division name
Department of Rehabilitation Science, Faculty of Health Sciences
Zip code
060-0812
Address
Kita 12 Nishi 5, Kita-Ku, Sapporo, Hokkaido, Japan
TEL
011-706-3390
Homepage URL
kasahara@hs.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
Hokkaido University
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
Hokkaido University, Department of Rehabilitation Science, Faculty of Health Sciences
Address
Kita 12 Nishi 5, Kita-Ku, Sapporo, Hokkaido, Japan
Tel
011-706-3316
shomu@hs.hokudai.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
| 2026 | Year | 07 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2027 | 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
| 2026 | Year | 04 | Month | 09 | Day |
Last modified on
| 2026 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070045
