Manual Acupuncture for Primary Dysmenorrhea
Primary Dysmenorrhea
About this trial
This is an interventional treatment trial for Primary Dysmenorrhea focused on measuring Acupuncture, Primary Dysmenorrhea, Randomized Controlled Trial, Placebo Effect
Eligibility Criteria
Inclusion Criteria:
- Diagnosed with PD according to the primary dysmenorrhea established by Canadian Institute of Obstetrics and gynecology in 2005;
- Aged from 15 to 40 years, have not given birth, and have a history of regular menstrual cycles (28 days±7 days);
- Pain of intensity is moderate varying from 40 to 80 on the visual analogue scale (VAS), and lasting at least 6 months;
- Able to complete the baseline dysmenorrhea diary;
- Able to sign an informed consent
Exclusion Criteria:
- Secondary dysmenorrhea caused by endometriosis, pelvic inflammation, myomas of uterus or other gynecological problems confirmed by type-B ultrasound exam by gynecologists;
- Have a history of pelvic or abdominal surgery, or applying oral contraceptives or intrauterine devices;
- Combined with uncontrolled diagnosed psychiatric disorders such as severe anxiety and depression, or severe systemic diseases affecting the implementation of treatment programs;
- Taking analgesics such as NSAIDs or having received any other treatment for PD three months prior to enrollment;
- Women in lactation, pregnant women, or those with plans to get pregnant during any period of the trial;
- Have experience of acupuncture;
- Illiterate, or patients unable to read and understand scales.
Sites / Locations
- Department of Neurology of Tongji Hospital, Huazhong University of Science and TechnologyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Sham Comparator
Placebo Comparator
Verum acupuncture
Sham acupuncture
Usual care
Participants will receive verum acupuncture plus usual care. Participants will receive acupuncture treatment start from the 5th or 7th day before the estimated first day of menstrual cycle, and for each cycle, participants will receive one session of treatment each day for 5 consecutive days, totally be treated with 15 sessions.Verum needles will be inserted into the skin and manipulated manually until deqi occurs. The needles are retained for 30 min in each session. During the treatment, the acupuncturist inquires the patient about deqi sensations and manipulates the needles to maintain the intensity of deqi. Participants will receive the same usual care as those in the usual care group.
Participants will receive sham acupuncture plus usual care. The Streitberger placebo needle will be placed at non-acupuncture points which are distant from the meridian parts and not located on the same neuromuscular segments as the prescribed points used in the VA group, so as to minimize any therapeutic and segmental effects. The same acupuncture schedule as that in the verum acupuncture group will be applied. The needles are retained for 30 min in each session. During the treatment, the acupuncturist inquires the patient about deqi sensations and pretends to manipulate the needles but deqi is not sought.Participants will receive the same usual care as those in the usual care group.
Participants will not receive acupuncture treatment besides health education as a control group.