UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054634 |
|---|---|
| Receipt number | R000062390 |
| Scientific Title | Randomised controlled trial on the efficacy of press tack needles stimulation for menstrual pain. |
| Date of disclosure of the study information | 2024/06/12 |
| Last modified on | 2025/06/13 12:25:20 |
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Basic information
Public title
Randomised controlled trial on the efficacy of press tack needles stimulation for menstrual pain.
Acronym
Randomised controlled trial on the efficacy of press tack needles stimulation for menstrual pain.
Scientific Title
Randomised controlled trial on the efficacy of press tack needles stimulation for menstrual pain.
Scientific Title:Acronym
Randomised controlled trial on the efficacy of press tack needles stimulation for menstrual pain.
Region
| Japan |
Condition
Condition
menstrual pain
Classification by specialty
| Medicine in general | Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effectiveness of press tack needles stimulation in women with menstrual pain.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Assessment of menstrual pain using the Visual analogus scale.
Key secondary outcomes
[Before intervention]
Questionnaire on menstruation
Cornel medical Index
Self rating Depression Scale
State Trait Anxiety Inventory
[every menstrual period]
Short Form McGill Pain Questionnaire
Medication status per menstruation
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
thumbtack needles
Interventions/Control_2
sham thumbtack needles
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
| Not applicable |
Gender
Female
Key inclusion criteria
Menstruating women with menstrual pain
Key exclusion criteria
Women with amenorrhoea lasting more than 3 months or menopausal women.
Women who have given birth
Those with any kind of systemic skin disease or local skin symptoms of irritation
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Sazu |
| Middle name | |
| Last name | Taniguchi |
Organization
Tokyo Ariake University of Medical and Health Science
Division name
Department of Acupuncture and Moxibustion
Zip code
135-0063
Address
2-9-1 Ariake Koto-ku, Tokyo 135-0063 Japan
TEL
03-6703-7000
taniguchisazu@tau.ac.jp
Public contact
Name of contact person
| 1st name | Sazu |
| Middle name | |
| Last name | Taniguchi |
Organization
Tokyo Ariake University of Medical and Health Science
Division name
Department of Acupuncture and Moxibustion
Zip code
135-0063
Address
2-9-1 Ariake Koto-ku, Tokyo 135-0063 Japan
TEL
03-6703-7000
Homepage URL
taniguchisazu@tau.ac.jp
Sponsor or person
Institute
Tokyo Ariake University of Medical and Health Science
Institute
Department
Personal name
Sazu Taniguchi
Funding Source
Organization
Tokyo Ariake University of Medical and Health Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Ariake University of Medical and Health Science
Address
2-9-1 Ariake Koto-ku, Tokyo 135-0063 Japan
Tel
03-6703-7000
taniguchisazu@tau.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
| 2024 | Year | 06 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 13 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 17 | Day |
Last follow-up date
| 2026 | 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
| 2024 | Year | 06 | Month | 12 | Day |
Last modified on
| 2025 | Year | 06 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062390
