UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019134 |
|---|---|
| Receipt number | R000022121 |
| Scientific Title | MRI evaluation of the effects of hyperbaric oxygen on athletes with soft tissue injuries |
| Date of disclosure of the study information | 2015/09/28 |
| Last modified on | 2019/10/01 09:12:18 |
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Basic information
Public title
MRI evaluation of the effects of hyperbaric oxygen on athletes with soft tissue injuries
Acronym
MRI evaluation of the effects of HBO on soft tissue injuries
Scientific Title
MRI evaluation of the effects of hyperbaric oxygen on athletes with soft tissue injuries
Scientific Title:Acronym
MRI evaluation of the effects of HBO on soft tissue injuries
Region
| Japan |
Condition
Condition
Hamstrings muscle strain
Medial collateral ligament injury of the knee
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purposes of this study were to evaluate the effects of hyperbaric oxygen therapy (HBO) on athletes with Hamstrings muscle strain and Medial collateral ligament injury of the knee by MRI, and to evaluate the effects of micro TE method for soft tissue injuries.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Comparison of MRI signal, physical examination, and visual analog scale just before HBO and after HBO on the same day.
2) MRI signal, physical examination, visual analog scale, and activity in 1 week, 3 weeks, and 6 weeks after injury for the evaluation of the healing acceleration effects of HBO.
3) Comparison of MRI signal of micro TE and normal imaging in healing process.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
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
| Medicine | Device,equipment |
Interventions/Control_1
Hyperbaric oxygen therapy/MRI
Interventions/Control_2
HBO:2.5 ATA for 60 minutes with oxygen inhalation
1 hour and 45 minutes including compression and depression.
HBO application once a day for 5 days, totally 5 times HBO application.
Interventions/Control_3
MRI:
In the HBO group, 5 times MRI( 1)after injury, 2) just after HBO, 3) 1 week, 4) 3 weeks, 5) 6 weeks after injury)
In the non-HBO group, 4 times MRI( 1)after injury, 2) 1 week, 3) 3 weeks, 4) 6 weeks after injury)
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 and Female
Key inclusion criteria
Athletes with isolated medial collateral ligament injury with no meniscus injury and no past history of knee injuries, and athletes with Hamstrings muscle strain with no past history of ipsilateral Hamstrings muscle strain.
Athletes who come to our hospital within 1 week from injury.
Key exclusion criteria
Athletes with no consent
Athletes with contra-indication for HBO in the HBO group.
<HBO Contra-indication>
Athletes with
1)impossible for equalizing pressure of the ear
2)claustrophobia
3)possibility of pregnancy
4)congenital pulmonary cystic diseases, and past history of pneumothorax
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuyoshi Yagishita |
Organization
Tokyo Medical and Dental University
Division name
Clinical Center for Sports Medicine and Sports Dentistry, Hyperbaric Medical Center
Zip code
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
+81-3-5803-5341
yagishita.orth@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuyoshi Yagishita |
Organization
Tokyo Medical and Dental University
Division name
Clinical Center for Sports Medicine and Sports Dentistry, Hyperbaric Medical Center
Zip code
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
+81-3-5803-5341
Homepage URL
yagishita.orth@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
HITACHI Medico 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
Address
Tel
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
| 2015 | Year | 09 | Month | 28 | 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
Completed
Date of protocol fixation
| 2015 | Year | 09 | Month | 28 | Day |
Date of IRB
| 2015 | Year | 09 | Month | 24 | Day |
Anticipated trial start date
| 2015 | Year | 09 | Month | 28 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 09 | Month | 28 | Day |
Last modified on
| 2019 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022121
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