UMIN-CTR Clinical Trial

Basic information
Public title	Investigation of the effects of acupuncture on pain threshold and the specificity of the acupoints
Acronym	The effects of acupuncture on pain threshold
Scientific Title	Investigation of the effects of acupuncture on pain threshold and the specificity of the acupoints
Scientific Title:Acronym	The effects of acupuncture on pain threshold
Region	Japan

Condition
Condition	healthy volunteer
Classification by specialty	Medicine in general Anesthesiology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effects of acupuncture on pain threshold and the specificity of the acupoints
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	pain threshold
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
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	Device,equipment
Interventions/Control_1	acupuncture on the forehead
Interventions/Control_2	acupuncture on the temporalhead
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	70 years-old >
Gender	Male and Female
Key inclusion criteria	Without past history of neck or upper limb trauma Without past history of chronic pain which is needed to treat Shoulder pain which does not disturb daily life Without past history of diabetes or systemic diseases Without cardiovascular diseases Without allergy of metal Without a knowledge of acupuncture Possible to obtain an informed consent
Key exclusion criteria	Past history of discomfort or hyphenation associated with acupuncture treatment Pregnancy Taking a drug to treat some diseases
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Shin Middle name Last name Takayama
Organization	Tohoku University Hospital
Division name	Department of Kampo Medicine
Zip code	980-8574
Address	1-1, Seiryomachi, Aobaku, Sendai city,Miyagi
TEL	022-717-7507
Email	tatahara1492@gmail.com

Public contact
Name of contact person	1st name Akiko Middle name Last name Kuwabara
Organization	Tohoku University Hospital
Division name	Department of Kampo Medicine
Zip code	980-8574
Address	1-1, Seiryomachi, Aobaku, Sendai city,Miyagi
TEL	022-717-8007
Homepage URL
Email	akiko.kuwabara.d7@tohoku.ac.jp

Sponsor
Institute	Tohoku University Hospital
Institute
Department

Funding Source
Organization	Grant-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization	Government offices of other countries
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Clinical Research Review Board, Tohoku University
Address	1-2, Seiryomachi, Aobaku, Miyagi
Tel	0227178007
Email	med-kenkyo@grp.tohoku.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

Other administrative information
Date of disclosure of the study information	2014 Year 05 Month 15 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	No longer recruiting
Date of protocol fixation	2014 Year 05 Month 01 Day
Date of IRB	2014 Year 04 Month 14 Day
Anticipated trial start date	2014 Year 05 Month 15 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 05 Month 15 Day
Last modified on	2020 Year 08 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016270