UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057291 |
|---|---|
| Receipt number | R000063241 |
| Scientific Title | The effect of icing for soft tissue as a first aid at the acute phase, and the effects of oxygen intake and hyperbaric oxygen environment on the side effect of icing. |
| Date of disclosure of the study information | 2025/03/17 |
| Last modified on | 2026/03/16 09:45:50 |
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Basic information
Public title
The effect of icing for soft tissue as a first aid at the acute phase, and the effects of oxygen intake and hyperbaric oxygen environment on the side effect of icing.
Acronym
The effect of icing for soft tissue and the effects of oxygen and hyperbaric oxygen.
Scientific Title
The effect of icing for soft tissue as a first aid at the acute phase, and the effects of oxygen intake and hyperbaric oxygen environment on the side effect of icing.
Scientific Title:Acronym
The effect of icing for soft tissue and the effects of oxygen and hyperbaric oxygen.
Region
| Japan |
Condition
Condition
normal subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
First aids for soft tissue injuries are RICE (R: Rest, I: Icing, C: Compression, E: Elevation) and POLICE (P: Protection, O: Optimal Loading, I: Icing, C: Compression, E: Elevation). However, the effect of icing procedure are predictively reported and there is concern that icing may induce a tissue hypoxic environment and delay healing.
The purposes of the study are to elucidate whether icing has a negative effect on the hypoxic environment in the lower limb and whether the addition of combined oxygen and hyperbaric oxygen environment is effective against the negative effects of icing on the lower limb.
The research aims to ensure early recovery and return to sport by providing appropriate treatment at an early stage on the sports field.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To assess the effects of icing (adverse effects) and whether icing plus oxygen or icing plus HBO can reduce the adverse effects of icing, icing, icing plus oxygen and icing plus HBO intervention groups are set up, with no intervention, oxygen only and HBO only groups as controls.
Then, transcutaneous oxygen partial pressure measurements, blood flow measurements, skin temperature measurements and foot and ankle joint volume measurements will be performed.
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
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Icing: submerge the foot in ice water approximately 15 cm from the sole and cool for 15 minutes. Icing will be performed on the right foot.
Interventions/Control_2
Oxygen administration: Oxygen is administered at 15 liters/minute using a reservoir mask.
Interventions/Control_3
Hyperbaric oxygen: 15 minutes at a pressure of 2 ATA. Plus, 10 min for compression and 10 min for decompression, for a total of 35 min.
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy adult subjects who agreed to participate in the study.
Key exclusion criteria
1) Inability to equalize the pressure
2) Claustrophobia
3) Pregnant or possibly pregnant women
4) Congenital cystic lung disease, pneumothorax, history of pneumothorax
5) Other cases where the investigator deems the subject unsuitable for the study.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Kazuyoshi |
| Middle name | |
| Last name | Yagishita |
Organization
Institute of Science Tokyo
Division name
Hyperbaric Medical Center, Clinical Center for Sports Medicine and Sports Dentistry
Zip code
1138519
Address
Yushima Campus: 1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5341
yagishita.orth@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Hoshino |
Organization
Institute of Science Tokyo
Division name
Clinical Center for Sports Medicine and Sports Dentistry
Zip code
1138519
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5341
Homepage URL
thoshino.orj@tmd.ac.jp
Sponsor or person
Institute
Institute of Science Tokyo
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency (JST)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institute of Science Tokyo
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
Tel
03-5803-4547
rinri.adm@tmd.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
| 2025 | Year | 03 | Month | 17 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 10 | Month | 25 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 13 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 07 | Day |
Last follow-up date
| 2026 | Year | 08 | 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 | 14 | Day |
Last modified on
| 2026 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063241
