UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025226 |
|---|---|
| Receipt number | 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 09:04:26 |
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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
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
kondo0207@k.tsukuba-tech.ac.jp
Sponsor or person
Institute
Tsukuba University of Technology, Faculty of Health Science
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029017
