Clinical trial NCT03977519: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Primary Dysmenorrhea
Keywords: primary dysmenorrhea
manual acupuncture
transcutaneous electric nerve stimulation
randomized controlled trial
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2019-06-06
Enrollment: 84
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: The proportion of patients with at least 50% reduction in mean pain intensity from baseline.
timeFrame: 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:
measure: Change of mean pain intensity from baseline measured by NRS.
timeFrame: 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)
measure: Change of the most severe pain intensity measured by NRS.
timeFrame: 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)
measure: Change of Cox Menstrual Symptom Scale(CMSS)
timeFrame: 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)
measure: Change of sick leave from baseline
timeFrame: 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)
measure: Change of pain duration from baseline
timeFrame: 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 outcomes:
measure: Pain medication intake
timeFrame: 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)
measure: Patients' satisfaction towards treatment.
timeFrame: 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)
Locations:
city: Beijing
country: China
facility: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
state: Beijing
Study officials:
affiliation: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
name: Jingxue Yuan
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.