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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025226
Receipt No. R000029017
Scientific Title Study on the effect of acupuncture treatment on headache
Date of disclosure of the study information 2016/12/12
Last modified on 2018/12/14

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Basic information
Public title Study on the effect of acupuncture treatment on headache
Acronym Study on the effect of acupuncture treatment on headache
Scientific Title Study on the effect of acupuncture treatment on headache
Scientific Title:Acronym Study on the effect of acupuncture treatment on headache
Region
Japan

Condition
Condition Tension type headache
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The effectiveness and cost effectiveness of acupuncture treatment for headache
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The degree of headache(VAS) for 1 week
Key secondary outcomes HIT-6, EQ-5D(Jpanese), Economic loss for headaches

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 acupuncture for 3 months
Interventions/Control_2
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
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Tension type headache patient
Key exclusion criteria Those who already have entered another clinical trials.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Kondo
Organization Tsukuba University of Technology
Division name Faculty of Health Science
Zip code
Address Kasuga 4-12-7, Tsukuba City, Ibaraki, Japan
TEL 029-852-2890
Email kondo0207@k.tsukuba-tech.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Kondo
Organization Tsukuba University of Technology
Division name Faculty of Health Science
Zip code
Address Kasuga 4-12-7, Tsukuba City, Ibaraki, Japan
TEL 029-852-2890
Homepage URL
Email kondo0207@k.tsukuba-tech.ac.jp

Sponsor
Institute Tsukuba University of Technology, Faculty of Health Science
Institute
Department

Funding Source
Organization National Acupuncture Moxibustion Massage Association
Organization
Division
Category of Funding Organization Other
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
2016 Year 12 Month 12 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
2016 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 01 Day
Last follow-up date
2017 Year 12 Month 31 Day
Date of closure to data entry
2018 Year 02 Month 01 Day
Date trial data considered complete
2018 Year 03 Month 01 Day
Date analysis concluded
2018 Year 05 Month 01 Day

Other
Other related information

Management information
Registered date
2016 Year 12 Month 12 Day
Last modified on
2018 Year 12 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029017

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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