Primary DysmenorrheaNCT03977519
Effect of MA Versus TENS for Primary Dysmenorrhea
A study testing MA and TENS in people with Primary Dysmenorrhea, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
Trial summary
The trial aims to evaluate the effect of manual acupuncture versus transcutaneous electric nerve stimulation in treating primary dysmenorrhea. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Primary Dysmenorrhea
- What is being tested?
- MA and TENS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- Jul 2019to May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, 100053
Jingxue Yuan, +86-18810969209, yuanjingxue@aliyun.com
About this study
Official title: Effect of Manual Acupuncture Versus Transcutaneous Electric Nerve Stimulation for Primary Dysmenorrhea: a Randomized Controlled Trial
The trial aims to evaluate the effect of manual acupuncture versus transcutaneous electric nerve stimulation in treating primary dysmenorrhea.
Read the 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.
- Conditions
- Primary Dysmenorrhea
- Being tested
- MA, TENS
- Keywords
- primary dysmenorrhea, manual acupuncture, transcutaneous electric nerve stimulation, randomized controlled trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAProcedure or surgery
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.
TENSProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| MA group | Experimental | Huatuo Brand needles (0.30×25mm,0.30×40mm or 0.30×75mm) will be used at EX-B8,BL32,SP8,and SP6. Receives: Procedure: MA |
| TENS group | Active comparator | 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. Receives: Procedure: TENS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 outcomes (5)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
Change of pain duration from baseline
Participates will be asked to record the pain duration(number of days with pain) in the menstrual period.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2019
- Study startJul 2019 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionMay 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Primary DysmenorrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jingxue Yuan, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Investigators
- Jingxue Yuan, Principal investigator, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03977519
- Sponsor's protocol ID
- 2018-176-KY
- Status last verified
- Jun 2019
- First submitted
- 27 May 2019
- Last updated
- 30 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 28625286Blodt 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.
PubMed 29155036Woo 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.
PubMed 29879061Proctor 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.
PubMed 11869624
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Manual Acupuncture Versus Transcutaneous Electric Nerve Stimulation for Primary Dysmenorrhea: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03977519
- Acronym / sponsor ID
- 2018-176-KY
- Conditions
- Primary Dysmenorrhea
- Keywords
- primary dysmenorrhea, manual acupuncture, transcutaneous electric nerve stimulation, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Study start
- Jul 2019 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 6 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MA group | Experimental | Procedure: MAHuatuo Brand needles (0.30×25mm,0.30×40mm or 0.30×75mm) will be used at EX-B8,BL32,SP8,and SP6. |
| TENS group | Active comparator | Procedure: TENSHuatuo 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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)；
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MAHuatuo 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 or surgery | MA group |
| TENSHuatuo 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. | Procedure or surgery | TENS group |
Primary outcome
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.
5 secondary outcomes
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)
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)
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)
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)
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2019.
- Background: PubMed 28625286Burnett 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.
- Background: PubMed 29155036Blodt 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.
- Background: PubMed 29879061Woo 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.
- Background: PubMed 11869624Proctor 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jingxue Yuan principal investigator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MA and TENS in people with Primary Dysmenorrhea, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jingxue Yuan (+86-18810969209, yuanjingxue@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03977519, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2019.