UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038363
Receipt number R000043721
Scientific Title Effect of acupuncture stimulation on Kenkobanten on hip joint external range of motion
Date of disclosure of the study information 2019/10/30
Last modified on 2020/04/24 08:53:59

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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 or person

Institute

Kansai University of Health Sciences

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043721


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name