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The Efficacy of Different Doses of Acupuncture in Dysmenorrhea

Primary Purpose

Premenstrual Syndrome, Dysmenorrhea

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Conventional gynecologic treatment
Low dose acupuncture
High dose acupuncture
Sponsored by
Taipei City Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Premenstrual Syndrome focused on measuring Acupuncture, Premenstrual Syndrome, Dysmenorrhea, Autonomic nervous activity, TCM syndrome, Meridian

Eligibility Criteria

19 Years - 49 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Women within reproductive age (15 to 49 years)
  2. VAS≧4
  3. Women with a history of regular menstrual cycles (28days±7 days)
  4. Self-reported lower abdominal and pelvic, medial anterior thigh pain or low back pain associated with the onset of menses and lasting in 72 hours.

4.Symptoms: dysmenorrhagia, breast pain, dizziness, bloating, cramps, nausea, vomiting, diarrhea, headache, fatigue, etc.

Exclusion Criteria:

  1. Women with irregular menstrual cycles
  2. Women use of an intrauterine contraceptive device (IUCD/IUD)
  3. Women with uncontrolled neurological diseases
  4. Lactation, pregnant women, or those with plans to get pregnant in the coming half year

Sites / Locations

  • Taipei City H

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Conventional Gynecologic Treatment group

Low dose acupuncture group

High dose acupuncture group

Arm Description

Taking NSAIDs or oral contraceptives.NSAIDs include Ibuprofen, Naproxen, Diclofenac, and Piroxicam. Oral contraceptives include Yasmin.

Acupuncture has fewer acupuncture points.

Acupuncture has more acupuncture points.

Outcomes

Primary Outcome Measures

Wang Qi Chinese Medicine Questionnaire
This questionnaire is used to survey TCM constitutions. Evaluate body constitution of each individual by score(Balanced Constitution, Qi-deficient Constitution, Yang-deficient Constitution, Yin-deficient Constitution, Phlegm-dampness Constitution, Damp-heat Constitution, Stagnant Blood Constitution, Stagnant Qi Constitution, and Inherited Special Constitution).
Heart rate variation (HRV) test
HRV test include time domain analysis and frequency domain analysis.Time domain analysis includes SDNN, R-MSSD and pNN50. Frequency domain analysis includes LF, HF, LF/HF and total power.

Secondary Outcome Measures

Visual analogue scale(VAS) score
VAS is used to assess the extent of menstrual pain.
Verbal multidimensional scoring system (VMSS) assessment
VMSS is used to assess the severity of dysmenorrhea. The VMSS assessment ranges from zero, one, two and three grade for evaluating the working ability, the systemic symptoms and whether analgesia is required or not. Grade 0 indicates that menstruation is not painful and daily activity is unaffected. Grade 1 indicates that menstruation is painful but seldom inhibits normal activity; analgesics are seldom required; mild pain. Grade 2 indicates that daily activity is affected; analgesics required and give sufficient relief so that absence from school is unusual; moderate pain. Grade 3 indicates that activity clearly inhibited; poor effect of analgesics; vegetative symptoms (headache, fatigue, vomiting, and diarrhea); severe pain.
SF-12 Health Survey
SF-12 health survey is a questionnaire used to assess the quality of life of individuals. It contains a total of 12 questions and can be aggregated into physiological facets and psychological facets to assess the physiological and mental health status of the subjects.
Blood test
Contain:estrogen, progesterone and prostaglandin
Menstrual Distress Questionnaire(MDQ)
Contain: Pain;Concentration;Behavioral Change;Autonomic Reactions;Water Retention;Negative Affect

Full Information

First Posted
November 1, 2018
Last Updated
March 18, 2019
Sponsor
Taipei City Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03881319
Brief Title
The Efficacy of Different Doses of Acupuncture in Dysmenorrhea
Official Title
The Study of Efficacy and Effect of Different Dose Acupuncture on Autonomic Nervous Activity and Quality of Life in Women With Dysmenorrhea
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei City Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Subjects in this study included premenstrual syndrome and dysmenorrhea. Premenstrual syndrome (PMS) is the sum of a group of symptoms (including physical and psychological symptoms) that occurs during the luteal phase of the menstrual cycle. Dysmenorrhea is a sort of period pelvic pain, caused by blood flow decrease abruptly and ischemia due to frequent contraction of the uterus. In clinical practice, gynecologists apply analgesic such as Non-steroidal Anti- inflammatory Drugs (NSAIDs), and oral contraceptive pills (OCT) or progestin as conventional therapy for premenstrual syndrome and dysmenorrhea. As NSAIDs may cause gastrointestinal discomfort, dyspepsia while hormone therapy leads to other concerns; some women now adopt acupuncture as an alternative therapy for its safety. However, many parameters affect the efficacy of acupuncture, such as the sorts of acupoints (of which meridians) or the numbers of acupoints; and proper evidence-based medicine on this issue is few. Therefore, in this study, we aim to evaluate 1. The different impact of acupuncture and conventional therapy in premenstrual syndrome and dysmenorrhea women ; 2. Will the character (of which meridians) or numbers of acupoints be affecting factors of efficacy in treating premenstrual syndrome and dysmenorrhea? 3. Shall there be any relationship between the acupuncture and autonomic nerve activity adjustment in premenstrual syndrome and dysmenorrhea? 4. Shall there be any relationship between the acupuncture and TCM syndrome adjustment in premenstrual syndrome and dysmenorrhea?
Detailed Description
Subjects in this study included premenstrual syndrome and dysmenorrhea. Premenstrual syndrome (PMS) is the sum of a group of symptoms (including physical and psychological symptoms) that occurs during the luteal phase of the menstrual cycle. Women who have such symptoms have been estimated as high as 75%; of which 3% to 8% are severe symptoms, called premenstrual dysphoric disorder (premenstrual dysphoric syndrome, PMDD). The two groups are very similar. Premenstrual syndrome is mostly for physical discomfort, while premenstrual dysphoric syndrome is for emotional problems, affecting women's sleep seriously. Dysmenorrhea is a sort of period pelvic pain, caused by blood flow decrease abruptly and ischemia due to frequent contraction of the uterus. Many females afflicted with dysmenorrhea to different extents; some suffered from depression, reduced the quality of life; others even need to withdraw from work or school for incapable of daily activity. Thus, dysmenorrhea causes a lot of health burden and worth our attention. The prevalence of dysmenorrhea is up to 50 %. Generally speaking, primary dysmenorrhea is a menstrual pain in the absence of pelvic pathology while secondary dysmenorrhea is caused by organic dysfunction such as endometriosis, uterus malformation, cervix structure, pelvic inflammation, etc. In clinical practice, gynecologists apply analgesic such as Non-steroidal Anti- inflammatory Drugs (NSAIDs), and oral contraceptive pills (OCT) or progestin as conventional therapy for premenstrual syndrome and dysmenorrhea. As NSAIDs may cause gastrointestinal discomfort, dyspepsia while hormone therapy leads to other concerns; some women now adopt acupuncture as an alternative therapy for its safety. However, many parameters affect the efficacy of acupuncture, such as the sorts of acupoints (of which meridians) or the numbers of acupoints; and proper evidence-based medicine on this issue is few. According to the theory of Traditional Chinese Medicine, acupuncture regulates meridians' energy and coordinates yin/yang while the western medicine reveals that the mechanism of pain-control of acupuncture is relevant to the theory of neurophysiology and some neuropeptide releasing, such as endorphin. Additionally, in our previous study, we noted that the theory of yin/yang (meridian) is compatible with autonomic nerve theory. Since many symptoms women with Premenstrual Syndrome and dysmenorrhea suffered, such as poor sleep, anxiety, convulsion of the uterine muscle, are related to autonomic nerve dysfunction, we are intrigued to know whether or not the effect of acupuncture relates to adjusting autonomic nerve system. Therefore, in this study, we aim to evaluate 1. The different impact of acupuncture and conventional therapy in premenstrual syndrome and dysmenorrhea women ; 2. Will the character (of which meridians) or numbers of acupoints be affecting factors of efficacy in treating premenstrual syndrome and dysmenorrhea? 3. Shall there be any relationship between the acupuncture and autonomic nerve activity adjustment in premenstrual syndrome and dysmenorrhea? 4. Shall there be any relationship between the acupuncture and TCM syndrome adjustment in premenstrual syndrome and dysmenorrhea? We expect through this multidisciplinary study; we can coordinate not only the different viewpoints of both Chinese and western medicine but also verify the compatibility of the theory of yin/yang and autonomic nerve (parasympathetic/sympathetic). We look forward the study can not only be a reference for further evidence-based research but also by reconciling different perspectives of Chinese and western medicine, we can, in turn, promote the cross-talk of Chinese and Western medicine in practical and academic aspects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premenstrual Syndrome, Dysmenorrhea
Keywords
Acupuncture, Premenstrual Syndrome, Dysmenorrhea, Autonomic nervous activity, TCM syndrome, Meridian

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
105 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional Gynecologic Treatment group
Arm Type
Active Comparator
Arm Description
Taking NSAIDs or oral contraceptives.NSAIDs include Ibuprofen, Naproxen, Diclofenac, and Piroxicam. Oral contraceptives include Yasmin.
Arm Title
Low dose acupuncture group
Arm Type
Experimental
Arm Description
Acupuncture has fewer acupuncture points.
Arm Title
High dose acupuncture group
Arm Type
Experimental
Arm Description
Acupuncture has more acupuncture points.
Intervention Type
Drug
Intervention Name(s)
Conventional gynecologic treatment
Other Intervention Name(s)
NSAIDs or oral contraceptives treatment
Intervention Description
Taking NSAIDs or oral contraceptives.NSAIDs include Ibuprofen, Naproxen, Diclofenac, and Piroxicam. Oral contraceptives include Yasmin.
Intervention Type
Device
Intervention Name(s)
Low dose acupuncture
Intervention Description
Six acupoints: Three Yin Intersection( SP6)、Grandfather Grandson(SP4)、 Sea of Blood(SP10) 、Sea of Qi(RN6)、Origin Pass(RN4) 、Inner Pass(PC6)
Intervention Type
Device
Intervention Name(s)
High dose acupuncture
Intervention Description
Twelve acupoints: Three Yin Intersection( SP6)、Grandfather Grandson(SP4)、 Sea of Blood(SP10) 、Sea of Qi(RN6)、Origin Pass(RN4) 、Middle Extremity(RN3)、Inner Pass(PC6) 、Supreme Rush(LR3) 、Joining Valley(LI4) 、Supreme Stream(KI3) 、Uterus(EX-CA1) 、Leg Three Miles(ST36)
Primary Outcome Measure Information:
Title
Wang Qi Chinese Medicine Questionnaire
Description
This questionnaire is used to survey TCM constitutions. Evaluate body constitution of each individual by score(Balanced Constitution, Qi-deficient Constitution, Yang-deficient Constitution, Yin-deficient Constitution, Phlegm-dampness Constitution, Damp-heat Constitution, Stagnant Blood Constitution, Stagnant Qi Constitution, and Inherited Special Constitution).
Time Frame
We will evaluate separately at baseline and the end of cycle 4 (each cycle is 30 days). Change from Baseline TCM constitutions at 4 cycles (each cycle is 30 days). Time Frame: baseline and 4 cycles (each cycle is 30 days)
Title
Heart rate variation (HRV) test
Description
HRV test include time domain analysis and frequency domain analysis.Time domain analysis includes SDNN, R-MSSD and pNN50. Frequency domain analysis includes LF, HF, LF/HF and total power.
Time Frame
We will evaluate separately at baseline and the end of cycle 4 (each cycle is 30 days). Change from Baseline HRV parameter at 4 cycles (each cycle is 30 days). Time Frame: baseline and 4 cycles (each cycle is 30 days)
Secondary Outcome Measure Information:
Title
Visual analogue scale(VAS) score
Description
VAS is used to assess the extent of menstrual pain.
Time Frame
We will evaluate separately at baseline and the end of cycle 4 (each cycle is 30 days). Change from Baseline VAS score at 4 cycles (each cycle is 30 days). Time Frame: baseline and 4 cycles (each cycle is 30 days)
Title
Verbal multidimensional scoring system (VMSS) assessment
Description
VMSS is used to assess the severity of dysmenorrhea. The VMSS assessment ranges from zero, one, two and three grade for evaluating the working ability, the systemic symptoms and whether analgesia is required or not. Grade 0 indicates that menstruation is not painful and daily activity is unaffected. Grade 1 indicates that menstruation is painful but seldom inhibits normal activity; analgesics are seldom required; mild pain. Grade 2 indicates that daily activity is affected; analgesics required and give sufficient relief so that absence from school is unusual; moderate pain. Grade 3 indicates that activity clearly inhibited; poor effect of analgesics; vegetative symptoms (headache, fatigue, vomiting, and diarrhea); severe pain.
Time Frame
We will evaluate separately at baseline and the end of cycle 4 (each cycle is 30 days). Change from Baseline VMSS assessment at 4 cycles (each cycle is 30 days). Time Frame: baseline and 4 cycles (each cycle is 30 days)
Title
SF-12 Health Survey
Description
SF-12 health survey is a questionnaire used to assess the quality of life of individuals. It contains a total of 12 questions and can be aggregated into physiological facets and psychological facets to assess the physiological and mental health status of the subjects.
Time Frame
We will evaluate separately at baseline and the end of cycle 4 (each cycle is 30 days). Change from Baseline SF-12 Health Survey at 4 cycles (each cycle is 30 days). Time Frame: baseline and 4 cycles (each cycle is 30 days)
Title
Blood test
Description
Contain:estrogen, progesterone and prostaglandin
Time Frame
We will evaluate separately at baseline and the end of cycle 4 (each cycle is 30 days). Change from Baseline blood test at 4 cycles (each cycle is 30 days). Time Frame: baseline and 4 cycles (each cycle is 30 days)
Title
Menstrual Distress Questionnaire(MDQ)
Description
Contain: Pain;Concentration;Behavioral Change;Autonomic Reactions;Water Retention;Negative Affect
Time Frame
We will evaluate separately at baseline and the end of cycle 4 (each cycle is 30 days). Change from Baseline Menstrual Distress Questionnaire at 4 cycles (each cycle is 30 days). Time Frame: baseline and 4 cycles (each cycle is 30 days)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women within reproductive age (15 to 49 years) VAS≧4 Women with a history of regular menstrual cycles (28days±7 days) Self-reported lower abdominal and pelvic, medial anterior thigh pain or low back pain associated with the onset of menses and lasting in 72 hours. 4.Symptoms: dysmenorrhagia, breast pain, dizziness, bloating, cramps, nausea, vomiting, diarrhea, headache, fatigue, etc. Exclusion Criteria: Women with irregular menstrual cycles Women use of an intrauterine contraceptive device (IUCD/IUD) Women with uncontrolled neurological diseases Lactation, pregnant women, or those with plans to get pregnant in the coming half year
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tsai-Ju Chien, PhD degree
Organizational Affiliation
Taipei City Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yi-Shuo Huang, B.S. degree
Organizational Affiliation
Taipei City Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Taipei City H
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
This study will have a continuous plan.

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The Efficacy of Different Doses of Acupuncture in Dysmenorrhea

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