Effect of MA Versus TENS for Primary Dysmenorrhea

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Status: Unknown

Conditions: Primary Dysmenorrhea

Treatments: Procedure: TENS; Procedure: MA

Study type: Interventional

Funder types: Other

Identifiers

NCT03977519

2018-176-KY

Details and patient eligibility

About

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

Full 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.

Enrollment: 84 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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84 participants in 2 patient groups

MA group

Experimental group

Description:

Huatuo Brand needles (0.30×25mm,0.30×40mm or 0.30×75mm) will be used at EX-B8,BL32,SP8,and SP6.

Treatment:

Procedure: MA

TENS group

Active Comparator group

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.

Treatment:

Procedure: TENS