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出境医 / 临床实验 / Effect of MA Versus TENS for Primary Dysmenorrhea

Effect of MA Versus TENS for Primary Dysmenorrhea

Study Description
Brief Summary:
The trial aims to evaluate the effect of manual acupuncture versus transcutaneous electric nerve stimulation in treating primary dysmenorrhea.

Condition or disease Intervention/treatment Phase
Primary Dysmenorrhea Procedure: MA Procedure: TENS Not Applicable

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.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Manual Acupuncture Versus Transcutaneous Electric Nerve Stimulation for Primary Dysmenorrhea: a Randomized Controlled Trial
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : May 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: MA group
Huatuo Brand needles (0.30×25mm,0.30×40mm or 0.30×75mm) will be used at EX-B8,BL32,SP8,and SP6.
Procedure: MA
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.

Active Comparator: TENS group
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.
Procedure: TENS
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.

Outcome Measures
Primary Outcome Measures :
  1. 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) ]
    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 :
  1. Change of mean pain intensity from baseline measured by NRS. [ 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) ]
    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.

  2. Change of the most severe pain intensity measured by NRS. [ 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) ]
    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.

  3. Change of Cox Menstrual Symptom Scale(CMSS) [ 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) ]

    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.


  4. Change of sick leave from 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) ]
    Sick leave(the days of absence from work or school due to menstrual pain) will be recorded by participates.

  5. Change of pain duration from 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) ]
    Participates will be asked to record the pain duration(number of days with pain) in the menstrual period.


Other Outcome Measures:
  1. Pain medication intake [ 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) ]
    Participates will be asked to record the doses and frequency of pain-relief drugs they have taken.

  2. Patients' satisfaction towards treatment. [ 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) ]
    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.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Female;
  2. Aged of 18 to 40 years;
  3. 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.
  4. With normal menstrual cycle(28±7 days) and normal menstrual period(3-7days);
  5. Menstrual mean pain score ≥4 on the numerical rating scale (NRS);
  6. To sign the informed consent and participate in the study voluntarily.

Exclusion Criteria:

  1. Secondary dysmenorrhea;
  2. Pregnant patients,lactating patients or patients preparing pregnancy.
  3. Subjects with serious heart, liver, kidney damage or cognitive impairment, aphasia, mental disorders, or the inability to cooperate with the examination and treatment;
  4. Subjects with coagulation dysfunction or anticoagulants such as warfarin and heparin have been used all the time;
  5. Subjects installed with the cardiac pacemaker;
  6. Those who have received relevant acupuncture, transcutaneous electric nerve stimulation and other treatment (except pain medication) the last three months;
  7. Patients who may be allergic to electrodes.
Contacts and Locations

Contacts
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Contact: Jingxue Yuan +86-18810969209 yuanjingxue@aliyun.com

Locations
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China, Beijing
Guang'anmen Hospital of China Academy of Chinese Medical Sciences Recruiting
Beijing, Beijing, China, 100053
Contact: Jingxue Yuan    +86-18810969209    yuanjingxue@aliyun.com   
Sponsors and Collaborators
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Investigators
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Principal Investigator: Jingxue Yuan Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Tracking Information
First Submitted Date  ICMJE May 27, 2019
First Posted Date  ICMJE June 6, 2019
Last Update Posted Date July 30, 2019
Estimated Study Start Date  ICMJE July 2019
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 5, 2019)
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) ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 5, 2019)
  • Change of mean pain intensity from baseline measured by NRS. [ 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) ]
    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. [ 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) ]
    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) [ 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) ]
    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 [ 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) ]
    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 [ 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) ]
    Participates will be asked to record the pain duration(number of days with pain) in the menstrual period.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 5, 2019)
  • Pain medication intake [ 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) ]
    Participates will be asked to record the doses and frequency of pain-relief drugs they have taken.
  • Patients' satisfaction towards treatment. [ 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) ]
    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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Effect of MA Versus TENS for Primary Dysmenorrhea
Official Title  ICMJE Effect of Manual Acupuncture Versus Transcutaneous Electric Nerve Stimulation for Primary Dysmenorrhea: a Randomized Controlled Trial
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Primary Dysmenorrhea
Intervention  ICMJE
  • Procedure: MA
    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.
  • Procedure: TENS
    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.
Study Arms  ICMJE
  • Experimental: MA group
    Huatuo Brand needles (0.30×25mm,0.30×40mm or 0.30×75mm) will be used at EX-B8,BL32,SP8,and SP6.
    Intervention: Procedure: MA
  • Active Comparator: TENS group
    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: Procedure: TENS
Publications *
  • 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.
  • Blödt 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.
  • 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. Review.
  • Proctor ML, Smith CA, Farquhar CM, Stones RW. Transcutaneous electrical nerve stimulation and acupuncture for primary dysmenorrhoea. Cochrane Database Syst Rev. 2002;(1):CD002123. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 5, 2019)
84
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2021
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Female;
  2. Aged of 18 to 40 years;
  3. 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.
  4. With normal menstrual cycle(28±7 days) and normal menstrual period(3-7days);
  5. Menstrual mean pain score ≥4 on the numerical rating scale (NRS);
  6. To sign the informed consent and participate in the study voluntarily.

Exclusion Criteria:

  1. Secondary dysmenorrhea;
  2. Pregnant patients,lactating patients or patients preparing pregnancy.
  3. Subjects with serious heart, liver, kidney damage or cognitive impairment, aphasia, mental disorders, or the inability to cooperate with the examination and treatment;
  4. Subjects with coagulation dysfunction or anticoagulants such as warfarin and heparin have been used all the time;
  5. Subjects installed with the cardiac pacemaker;
  6. Those who have received relevant acupuncture, transcutaneous electric nerve stimulation and other treatment (except pain medication) the last three months;
  7. Patients who may be allergic to electrodes.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03977519
Other Study ID Numbers  ICMJE 2018-176-KY
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Jingxue Yuan, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Study Sponsor  ICMJE Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jingxue Yuan Guang'anmen Hospital of China Academy of Chinese Medical Sciences
PRS Account Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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