Back to resultsEffect of MA Versus TENS for Primary Dysmenorrhea
Primary Purpose
Primary Dysmenorrhea
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
MA
TENS
Sponsored by
About this trial
This is an interventional treatment trial for Primary Dysmenorrhea focused on measuring primary dysmenorrhea, manual acupuncture, transcutaneous electric nerve stimulation, randomized controlled trial
Eligibility Criteria
Inclusion Criteria:
- Female;
- Aged of 18 to 40 years;
- Conforming to the criteria for the diagnosis of primary dysmenorrhea in the guideline developed by Society of Obstetricians and Gynaecologists of Canada（SOGC）in 2017.
- With normal menstrual cycle(28±7 days) and normal menstrual period（3-7days）；
- Menstrual mean pain score ≥4 on the numerical rating scale (NRS)；
- To sign the informed consent and participate in the study voluntarily.
Exclusion Criteria:
- Secondary dysmenorrhea;
- Pregnant patients,lactating patients or patients preparing pregnancy.
- Subjects with serious heart, liver, kidney damage or cognitive impairment, aphasia, mental disorders, or the inability to cooperate with the examination and treatment;
- Subjects with coagulation dysfunction or anticoagulants such as warfarin and heparin have been used all the time;
- Subjects installed with the cardiac pacemaker;
- Those who have received relevant acupuncture, transcutaneous electric nerve stimulation and other treatment (except pain medication) the last three months;
- Patients who may be allergic to electrodes.
Sites / Locations
- Guang'anmen Hospital of China Academy of Chinese Medical SciencesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
MA group
TENS group
Arm Description
Huatuo Brand needles (0.30×25mm,0.30×40mm or 0.30×75mm) will be used at EX-B8,BL32,SP8,and SP6.
Huatuo Brand electrode patch (50mm×50mm) and the SDZ-V EA apparatus (Suzhou Medical Appliance) will be used to stimulate the area along the lower borders of the ribs and the upper borders of the hip crests on both sides.The parameters of the electric acupuncture apparatus：Continuous wave,the frequency is 100Hz, the current intensity is 2.5mA-5mA.
Outcomes
Primary Outcome Measures
The proportion of patients with at least 50% reduction in mean pain intensity from baseline.
The pain intensity was measured by the Numerical Rating Scale (NRS), which is a valid measure of pain intensity with scores from 0 (no pain) to 10 (worst possible pain).Participants will be asked to rate their mean pain intensity on the days with pain during the third menstruation by selecting a single number from 0 to 10.The primary outcome is the proportion of patients with at least 50% reduction in mean pain intensity from baseline.
Secondary Outcome Measures
Change of mean pain intensity from baseline measured by NRS.
The Numerical Rating Scale (NRS) is a valid measure of pain intensity with scores from 0 (no pain) to 10 (worst possible pain).Participants will be asked to rate their mean pain intensity on the days with pain during the menstruation by selecting a single number from 0 to 10.The outcome is the changed number of numerical rating scale(NRS)of mean pain intensity on the days with pain during the menstruation compared with baseline.
Change of the most severe pain intensity measured by NRS.
The Numerical Rating Scale (NRS) is a valid measure of pain intensity with scores from 0 (no pain) to 10 (worst possible pain).Participants will be asked to rate their worst pain intensity during the menstruation by selecting a single number from 0 to 10.The outcome is the changed number of numerical rating scale(NRS)of worst pain intensity during the menstruation compared with baseline.
Change of Cox Menstrual Symptom Scale(CMSS)
CMSS is a tool for evaluating patients' symptom integrally which consists of 17 items or symptoms.In severity evaluation,each symptom is scored in five levels: 0 represent symptoms not noticeable;1, slightly bothersome;2, moderate bothersome; 3, severely bothersome;4, very severely bothersome.
In the duration of the evaluation,each variable is scored in five grades by the retained time of symptom: 0 score denote did not occur;1, lasted less than 3h; 2, lasted 3 to 7h;3, lasted an entire day;and 4, lasted several days.
Change of sick leave from baseline
Sick leave(the days of absence from work or school due to menstrual pain) will be recorded by participates.
Change of pain duration from baseline
Participates will be asked to record the pain duration(number of days with pain) in the menstrual period.
Full Information
NCT ID
NCT03977519
First Posted
May 27, 2019
Last Updated
July 27, 2019
Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT03977519
Brief Title
Effect of MA Versus TENS for Primary Dysmenorrhea
Official Title
Effect of Manual Acupuncture Versus Transcutaneous Electric Nerve Stimulation for Primary Dysmenorrhea: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 2019 (Anticipated)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
May 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The trial aims to evaluate the effect of manual acupuncture versus transcutaneous electric nerve stimulation in treating primary dysmenorrhea.
Detailed Description
According to systematic reviews,manual acupuncture(MA) and high frequency transcutaneous electric nerve stimulation(TENS) had certain therapeutic effects on primary dysmenorrhea respectively.
In this trial, 84 patients with primary dysmenorrhea will be recruited and randomly allocated into MA group and TENS group. Patients in MA group will receive treatment at acupoints of Shiqizhui(EX-B8), Ciliao(BL 32),Diji(SP 8) and Sanyinjiao(SP 6) and those in TENS group will receive treatment at the area along the lower borders of the ribs and the upper borders of the hip crests on both sides. All patients, both in EA group and TENS group, will be treated in their first day of dysmenorrhea, once a day for three consecutive days. And the treatments will last for three consecutive menstrual cycles.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Dysmenorrhea
Keywords
primary dysmenorrhea, manual acupuncture, transcutaneous electric nerve stimulation, randomized controlled trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
84 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MA group
Arm Type
Experimental
Arm Description
Huatuo Brand needles (0.30×25mm,0.30×40mm or 0.30×75mm) will be used at EX-B8,BL32,SP8,and SP6.
Arm Title
TENS group
Arm Type
Active Comparator
Arm Description
Huatuo Brand electrode patch (50mm×50mm) and the SDZ-V EA apparatus (Suzhou Medical Appliance) will be used to stimulate the area along the lower borders of the ribs and the upper borders of the hip crests on both sides.The parameters of the electric acupuncture apparatus：Continuous wave,the frequency is 100Hz, the current intensity is 2.5mA-5mA.
Intervention Type
Procedure
Intervention Name(s)
MA
Intervention Description
Huatuo Brand needles (0.30×25mm,0.30×40mm or 0.30×75mm) will be used.Participants will receive manual acupuncture for 30 minutes each time.After acupuncture,we will twist the needles every 10 minutes for about 30 seconds.The patients will be treated in their first day of dysmenorrhea, once a day for three consecutive days. And the treatments will last for three consecutive menstrual cycles.
Intervention Type
Procedure
Intervention Name(s)
TENS
Intervention Description
Huatuo Brand electrode patch (50mm×50mm) and the SDZ-V EA apparatus (Suzhou Medical Appliance) will be used.Participants will receive transcutaneous electric nerve stimulation for 30 minutes each time.They will be treated in their first day of dysmenorrhea, once a day for three consecutive days. And the treatments will last for three consecutive menstrual cycles.
Primary Outcome Measure Information:
Title
The proportion of patients with at least 50% reduction in mean pain intensity from baseline.
Description
The pain intensity was measured by the Numerical Rating Scale (NRS), which is a valid measure of pain intensity with scores from 0 (no pain) to 10 (worst possible pain).Participants will be asked to rate their mean pain intensity on the days with pain during the third menstruation by selecting a single number from 0 to 10.The primary outcome is the proportion of patients with at least 50% reduction in mean pain intensity from baseline.
Time Frame
Baseline；At the end of menstrual period of Cycle 3(each menstrual period is about 3-7 days,each cycle is about 28 days)
Secondary Outcome Measure Information:
Title
Change of mean pain intensity from baseline measured by NRS.
Description
The Numerical Rating Scale (NRS) is a valid measure of pain intensity with scores from 0 (no pain) to 10 (worst possible pain).Participants will be asked to rate their mean pain intensity on the days with pain during the menstruation by selecting a single number from 0 to 10.The outcome is the changed number of numerical rating scale(NRS)of mean pain intensity on the days with pain during the menstruation compared with baseline.
Time Frame
Baseline；At the end of menstrual period of Cycle 1,Cycle 2,Cycle 3 and Cycle 6(each menstrual period is about 3-7 days,each cycle is about 28 days)
Title
Change of the most severe pain intensity measured by NRS.
Description
The Numerical Rating Scale (NRS) is a valid measure of pain intensity with scores from 0 (no pain) to 10 (worst possible pain).Participants will be asked to rate their worst pain intensity during the menstruation by selecting a single number from 0 to 10.The outcome is the changed number of numerical rating scale(NRS)of worst pain intensity during the menstruation compared with baseline.
Time Frame
Baseline；At the end of menstrual period of Cycle 1,Cycle 2,Cycle 3 and Cycle 6(each menstrual period is about 3-7 days,each cycle is about 28 days)
Title
Change of Cox Menstrual Symptom Scale(CMSS)
Description
CMSS is a tool for evaluating patients' symptom integrally which consists of 17 items or symptoms.In severity evaluation,each symptom is scored in five levels: 0 represent symptoms not noticeable;1, slightly bothersome;2, moderate bothersome; 3, severely bothersome;4, very severely bothersome.
In the duration of the evaluation,each variable is scored in five grades by the retained time of symptom: 0 score denote did not occur;1, lasted less than 3h; 2, lasted 3 to 7h;3, lasted an entire day;and 4, lasted several days.
Time Frame
Baseline；At the end of menstrual period of Cycle 1,Cycle 2,Cycle 3 and Cycle 6(each menstrual period is about 3-7 days,each cycle is about 28 days)
Title
Change of sick leave from baseline
Description
Sick leave(the days of absence from work or school due to menstrual pain) will be recorded by participates.
Time Frame
Baseline；At the end of menstrual period of Cycle 1,Cycle 2,Cycle 3 and Cycle 6(each menstrual period is about 3-7 days,each cycle is about 28 days)
Title
Change of pain duration from baseline
Description
Participates will be asked to record the pain duration(number of days with pain) in the menstrual period.
Time Frame
Baseline；At the end of menstrual period of Cycle 1,Cycle 2,Cycle 3 and Cycle 6(each menstrual period is about 3-7 days,each cycle is about 28 days)
Other Pre-specified Outcome Measures:
Title
Pain medication intake
Description
Participates will be asked to record the doses and frequency of pain-relief drugs they have taken.
Time Frame
At the end of menstrual period of Cycle 1,Cycle 2,Cycle 3 and Cycle 6(each menstrual period is about 3-7 days,each cycle is about 28 days)
Title
Patients' satisfaction towards treatment.
Description
Patients will be asked to choice the satisfaction towards treatment.The satisfaction consist of dissatisfaction,a little satisfaction,moderate satisfaction,greater satisfaction and very satisfaction.
Time Frame
At the end of menstrual period of Cycle 3 and Cycle 6(each menstrual period is about 3-7 days,each cycle is about 28 days)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Female;
Aged of 18 to 40 years;
Conforming to the criteria for the diagnosis of primary dysmenorrhea in the guideline developed by Society of Obstetricians and Gynaecologists of Canada（SOGC）in 2017.
With normal menstrual cycle(28±7 days) and normal menstrual period（3-7days）；
Menstrual mean pain score ≥4 on the numerical rating scale (NRS)；
To sign the informed consent and participate in the study voluntarily.
Exclusion Criteria:
Secondary dysmenorrhea;
Pregnant patients,lactating patients or patients preparing pregnancy.
Subjects with serious heart, liver, kidney damage or cognitive impairment, aphasia, mental disorders, or the inability to cooperate with the examination and treatment;
Subjects with coagulation dysfunction or anticoagulants such as warfarin and heparin have been used all the time;
Subjects installed with the cardiac pacemaker;
Those who have received relevant acupuncture, transcutaneous electric nerve stimulation and other treatment (except pain medication) the last three months;
Patients who may be allergic to electrodes.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jingxue Yuan
Phone
+86-18810969209
Email
yuanjingxue@aliyun.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jingxue Yuan
Organizational Affiliation
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100053
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jingxue Yuan
Phone
+86-18810969209
Email
yuanjingxue@aliyun.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
28625286
Citation
Burnett M, Lemyre M. No. 345-Primary Dysmenorrhea Consensus Guideline. J Obstet Gynaecol Can. 2017 Jul;39(7):585-595. doi: 10.1016/j.jogc.2016.12.023.
Results Reference
background
PubMed Identifier
29155036
Citation
Blodt S, Pach D, Eisenhart-Rothe SV, Lotz F, Roll S, Icke K, Witt CM. Effectiveness of app-based self-acupressure for women with menstrual pain compared to usual care: a randomized pragmatic trial. Am J Obstet Gynecol. 2018 Feb;218(2):227.e1-227.e9. doi: 10.1016/j.ajog.2017.11.570. Epub 2017 Nov 15.
Results Reference
background
PubMed Identifier
29879061
Citation
Woo HL, Ji HR, Pak YK, Lee H, Heo SJ, Lee JM, Park KS. The efficacy and safety of acupuncture in women with primary dysmenorrhea: A systematic review and meta-analysis. Medicine (Baltimore). 2018 Jun;97(23):e11007. doi: 10.1097/MD.0000000000011007.
Results Reference
background
PubMed Identifier
11869624
Citation
Proctor ML, Smith CA, Farquhar CM, Stones RW. Transcutaneous electrical nerve stimulation and acupuncture for primary dysmenorrhoea. Cochrane Database Syst Rev. 2002;2002(1):CD002123. doi: 10.1002/14651858.CD002123.
Results Reference
background
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Effect of MA Versus TENS for Primary Dysmenorrhea
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