UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013967 |
|---|---|
| Receipt number | R000016270 |
| Scientific Title | Investigation of the effects of acupuncture on pain threshold and the specificity of the acupoints |
| Date of disclosure of the study information | 2014/05/15 |
| Last modified on | 2020/08/04 13:49:31 |
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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
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
akiko.kuwabara.d7@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016270
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
