UMIN-CTR Clinical Trial

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
Email	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
Email	yagishita.orth@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental University
Institute
Department

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
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022121