UMIN-CTR Clinical Trial

Basic information
Public title	Effect of acupuncture stimulation on the acupoint Kenkobanten located below the axilla on the hip external rotation range
Acronym	Effect of acupuncture stimulation on Kenkobanten on hip joint external range of motion
Scientific Title	Effect of acupuncture stimulation on Kenkobanten on hip joint external range of motion
Scientific Title:Acronym	Effect of acupuncture stimulation on Kenkobanten on hip joint external range of motion
Region	Japan

Condition
Condition	Lower hip external rotation range of motion
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Identical subjects for those who have hip joint rotation limitation, with acupuncture stimulation on the Kenkobanten, expanding the range of movement of the hip joint on the opposite side to the stimulation side and increasing the skin temperature around the lumbar region To verify compared with non-stimulated
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Hip joint external rotation range on the opposite side to the acupuncture stimulation side
Key secondary outcomes	Skin temperature around the lumbar region

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Non-randomized
Randomization unit
Blinding	Open -but 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	Maneuver
Interventions/Control_1	A method of stabbing the Kenkobanten to a depth of 10 mm and moving it up and down for 1 minute at a rate of 1 Hz.
Interventions/Control_2	Unstimulated
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Hip external rotation range of less than 45 degrees
Key exclusion criteria	Person with orthopedic disease
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Yusuke Middle name Last name Teraoka
Organization	Kansai University of Health Sciences
Division name	Department of Acupuncture-Moxibustion and Sports Trainer Science,Faculty of Health Sciences
Zip code	590-0482
Address	2-11-1 Wakaba, Kumatoricho, Sennan-gun, Osaka, Japan
TEL	072-453-8251
Email	teraoka@kansai.ac.jp

Public contact
Name of contact person	1st name Yusuke Middle name Last name Teraoka
Organization	Kansai University of Health Sciences
Division name	Department of Acupuncture-Moxibustion and Sports Trainer Science,Faculty of Health Sciences
Zip code	590-0482
Address	2-11-1 Wakaba, Kumatoricho, Sennan-gun, Osaka, Japan
TEL	072-453-8251
Homepage URL
Email	teraoka@kansai.ac.jp

Sponsor
Institute	Kansai University of Health Sciences
Institute
Department

Funding Source
Organization	Kansai University of Health Sciences
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	JAPAN

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

IRB Contact (For public release)
Organization	Kansai University of Health Sciences
Address	2-11-1 Wakaba, Kumatoricho, Sennan-gun, Osaka, Japan
Tel	072-453-8251
Email	k.kimura@kansai.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	関西医療大学（大阪府）

Other administrative information
Date of disclosure of the study information	2019 Year 10 Month 30 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	12
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	2019 Year 08 Month 07 Day
Date of IRB	2019 Year 08 Month 28 Day
Anticipated trial start date	2019 Year 10 Month 31 Day
Last follow-up date	2020 Year 03 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 10 Month 23 Day
Last modified on	2020 Year 04 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043721