UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018815
Receipt number R000021688
Scientific Title The research of effective somatosensory stimulation for menstrual pain and menstrual cycle accompanying symptoms.
Date of disclosure of the study information 2015/08/26
Last modified on 2017/03/13 13:48:36

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

The research of effective somatosensory stimulation for menstrual pain and menstrual cycle accompanying symptoms.

Acronym

Could be the menstrual pain relieved by gentle acupuncture stimulation?

Scientific Title

The research of effective somatosensory stimulation for menstrual pain and menstrual cycle accompanying symptoms.

Scientific Title:Acronym

Could be the menstrual pain relieved by gentle acupuncture stimulation?

Region

Japan


Condition

Condition

Primary Dysmenorrhea
(The menstrual pain without secondary factors. Secondary factor is endometriosis,myoma of the uterus, and so on.)

Classification by specialty

Obstetrics and Gynecology Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study purpose is to establish the easy method of self care for a working women or student with menstrual pain.
In anesthetized rats, the cutaneous stimulation for segmental area that belong to uterine (sacral nerve) was suggested that release the pain and increase the uterine blood flow.
Therefore, we examine the effects of non-noxious gentle acupuncture stimulation on skin area that is belong to sacral nerve that is expected to improve on ischemia of the uterine or release a pain, for women with menstrual pain.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase I,II


Assessment

Primary outcomes

In this study, as a primary outcome, assess the strength of menstrual pain by visual analog scale.

Key secondary outcomes

As a physiological outcome, assess the uterine artery blood flow (resistance index: RI) on menstrual phase.
And as another secondary outcomes, assess the another menstrual symptoms in addition to menstrual pain, and the count of used the analgesics, and assess the usefulness as a self care of cutaneous stimulation, by questionnaire.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

NO

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

In this study, as a real gentle acupuncture stimulation, paste the cutaneous stimulation tool of plastic disk (SOMARESON) that has micro cone on surface. As the placebo stimulation, use the plastic flat disk that has no micro cone on surface. Each stimulation applies on the back side of lower limb (the skin area that belong to sacral nerve) by participants oneself.
The first menstrual cycle, subjects records the baseline. Periods of the baseline, records the menstrual pain strength and other outcomes by the non-intervention.
In "interventions 1", only use the real stimulation.
After the periods of baseline, subjects applies the real stimulation on during periods of menstruation of four consecutive menstrual cycle, and records the menstrual pain strength and other outcomes on menstrual phase.

Interventions/Control_2

In this study, as a real gentle acupuncture stimulation, paste the cutaneous stimulation tool of plastic disk (SOMARESON) that has micro cone on surface. As the placebo stimulation, use the plastic flat disk that has no micro cone on surface. Each stimulation applies on the back side of lower limb (the skin area that belong to sacral nerve) by participants oneself.
The first menstrual cycle, subjects records the baseline. Periods of the baseline, records the menstrual pain strength and other outcomes by the non-intervention.
In "interventions 2", only use the placebo stimulation.
After the periods of baseline, Subjects applies the placebo stimulation on during periods of menstruation of four consecutive menstrual cycle, and records the menstrual pain strength and other outcomes on menstrual phase.

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

Female

Key inclusion criteria

Every women with menstrual pain(low abdominal pain or low back pain and so on )during recent 6 menstrual cycle.
Those women who has agreements of participates on paper in this study.

Key exclusion criteria

The subjects who has occurred a rash on skin that was pasted the tool of cutaneous stimulation.
The subjects who takes an oral contraceptive regularly.
The subjects who takes the pill by gynecology doctor indication at the present time.
The subjects who has gynecology disease or another underlying disease.
The subjects who has gynecology disease or another underlying disease (such as skin disease, diabetes, cardiovascular disease).

Target sample size

24


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Miyazaki Shogo

Organization

Teikyo Heisei University

Division name

Faculty of Health Care

Zip code


Address

2-51-4 Higashiikebukuro, Toshima-ku, Tokyo

TEL

03-5843-3111

Email

s.miyazaki@thu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Miyazaki Shogo

Organization

Teikyo Heisei University

Division name

Faculty of Health Care

Zip code


Address

2-51-4 Higashiikebukuro, Toshima-ku, Tokyo

TEL

03-5843-3111

Homepage URL


Email

s.miyazaki@thu.ac.jp


Sponsor or person

Institute

Teikyo Heisei University

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

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

帝京平成大学(東京都)/Teikyo Heisei University(Tokyo)


Other administrative information

Date of disclosure of the study information

2015 Year 08 Month 26 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

In the 14 participants (contact needle group: n=8, placebo needle group: n=6) who completed the study, the mean change in menstrual pain was assessed by using a 100-mm Visual Analogue Scale: -17.31 mm in the contact needle group and -18.83 mm in the placebo needle group. There was no intergroup difference (p=0.87, Cohen's d=0.09). Our findings suggest that self-care by contact needle therapy relieves menstrual pain. However, given that its effect on menstrual pain was equivalent to self-care by placebo needle therapy, the pain relief observed in this study might have been due to non-specific effects, such as placebo effects and acupressure effects.

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

2015 Year 08 Month 15 Day

Date of IRB


Anticipated trial start date

2015 Year 09 Month 01 Day

Last follow-up date

2016 Year 10 Month 01 Day

Date of closure to data entry

2016 Year 10 Month 01 Day

Date trial data considered complete

2016 Year 10 Month 01 Day

Date analysis concluded

2016 Year 10 Month 01 Day


Other

Other related information



Management information

Registered date

2015 Year 08 Month 26 Day

Last modified on

2017 Year 03 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021688


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name