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 |
The research of effective somatosensory stimulation for menstrual pain and menstrual cycle accompanying symptoms.
Could be the menstrual pain relieved by gentle acupuncture stimulation?
The research of effective somatosensory stimulation for menstrual pain and menstrual cycle accompanying symptoms.
Could be the menstrual pain relieved by gentle acupuncture stimulation?
Japan |
Primary Dysmenorrhea
(The menstrual pain without secondary factors. Secondary factor is endometriosis,myoma of the uterus, and so on.)
Obstetrics and Gynecology | Adult |
Others
NO
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.
Safety,Efficacy
Confirmatory
Pragmatic
Phase I,II
In this study, as a primary outcome, assess the strength of menstrual pain by visual analog scale.
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.
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
NO
YES
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Device,equipment |
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.
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.
16 | years-old | <= |
Not applicable |
Female
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.
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).
24
1st name | |
Middle name | |
Last name | Miyazaki Shogo |
Teikyo Heisei University
Faculty of Health Care
2-51-4 Higashiikebukuro, Toshima-ku, Tokyo
03-5843-3111
s.miyazaki@thu.ac.jp
1st name | |
Middle name | |
Last name | Miyazaki Shogo |
Teikyo Heisei University
Faculty of Health Care
2-51-4 Higashiikebukuro, Toshima-ku, Tokyo
03-5843-3111
s.miyazaki@thu.ac.jp
Teikyo Heisei University
None
Self funding
NO
帝京平成大学(東京都)/Teikyo Heisei University(Tokyo)
2015 | Year | 08 | Month | 26 | Day |
Unpublished
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.
Completed
2015 | Year | 08 | Month | 15 | Day |
2015 | Year | 09 | Month | 01 | Day |
2016 | Year | 10 | Month | 01 | Day |
2016 | Year | 10 | Month | 01 | Day |
2016 | Year | 10 | Month | 01 | Day |
2016 | Year | 10 | Month | 01 | Day |
2015 | Year | 08 | Month | 26 | Day |
2017 | Year | 03 | Month | 13 | Day |
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 |