UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of transcutaneous application of carbon dioxide on range of motion and skeletal muscle
Title of the study (Brief title)	The effect of transcutaneous application of carbon dioxide on range of motion and skeletal muscle
Region	Japan

Condition
Condition	healthy adult
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	to prove whether transcutaneous application of carbon dioxide is effective treatment for contracture
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	hip flection angle
Key secondary outcomes	pennation angle, muscle thichness, muscle fascicle length, and hardness of the hamstring

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -investigator(s) and assessor(s) are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	We will conduct transcutaneous application of carbon dioxide to participants 20minutes everyday for 2weeks.
Interventions/Control_2	We will conduct transcutaneous application of carbon dioxide to participants 40minutes everyday for 2weeks.
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male
Key inclusion criteria	male students of Kobe University
Key exclusion criteria	people having orthopedic disease
Target sample size	30

Research contact person
Name of lead principal investigator	Hideki Moriyama
Organization	Kobe University
Division name	Department of Rehabilitation Science, Graduate School of Health Science
Address	7-10-2 Tomogaoka Suma-ku Kobe-si Hyogo Japan
TEL	078-796-4574
Email	morihide@harbor.kobe-u.ac.jp

Public contact
Name of contact person	Takumi Ito
Organization	Kobe University
Division name	Department of Physical Therapy, School of Medicine Department of Health Science
Address	6-4-30-402 Ota-tyo Suma-ku Kobe-si Hyogo Japan
TEL	080-2785-9372
Homepage URL
Email	takutigers.v@gmail.com

Sponsor
Institute	Kobe University
Institute
Department

Funding Source
Organization	self sourcing
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	神戸大学保健学研究科（兵庫県）

Other administrative information
Date of disclosure of the study information	2018 Year 12 Month 14 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 04 Month 27 Day
Anticipated trial start date	2018 Year 12 Month 14 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 05 Month 17 Day
Last modified on	2018 Year 05 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037190