Acupuncture for Primary Dysmenorrhea: Examining the role of frequency of treatment and mode of stimulation on clinical outcomes

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2013
INTERVENTION: Manual acupuncture is provided by manual stimulation of the needle. Initial DeQi manually is obtained then manual stimulation at least once during the treatment session. Electro acupuncture is using an ITOH ES‐160 electro acupuncture machine. Initial DeQi is obtained manually then a 2/100Hz stimulation frequency is used. Arm 1: Manual acupuncture treatment delivered for 20‐30 minutes once per week starting the week after menses and then once in the first two days of the menstrual period for three menstrual cycles Arm 2: Manual acupuncture treatment delivered for 20‐30 minutes three times in the week prior to menses and then once in the first two days of the menstrual period for three menstrual cycles Arm 3: Electro acupuncture treatment delivered for 20‐30 minutes once per week starting the week after menses and then once in the first two days of the menstrual period for three menstrual cycles Arm 4: Electro acupuncture treatment delivered for 20‐30 minutes three times in the week prior to menses and then once in the first two days of the menstrual period for three menstrual cycles . All treatments are determined based on Traditional Chinese Medicine (TCM) diagnosis. A manualised protocol is used which allows selection from a number of suitable acupuncture points based on the TCM diagnosis. CONDITION: Primary Dysmenorrhea PRIMARY OUTCOME: Numerical rating scale (NRS) for pain. Each subject will keep a menstrual diary provided by the researcher. This will note the day of menses, average and maximum pain per day on an 11 point NRS with 0 being no pain and 10 being the worst pain imaginable. The primary endpoint is a 20% difference in NRS rated average pain severity between groups. SECONDARY OUTCOME: Duration of menstrual pain (hours) measured by the menstrual pain diary Health Related Quality of Life as measured by the Short Form Health Survey (SF‐36) Menstrual characteristics (flow/clots) measured by the menstrual pain diary Pain relief taken (type, dosage, number of doses) measured by the menstrual pain diary Patient satisfaction as measured by trial exit questionnaire non pharmacological interventions (heat,rest) measured by the menstrual pain diary secondary symptoms of dysmenorrhea (headache, vomiting etc) measured by the menstrual pain diary INCLUSION CRITERIA: Women with suspected or confirmed primary dysmenorrhea as defined by the following: * Age 18‐45 years * History of period pain beginning before the age of 18 OR after the age of 18 with negative screening for secondary dysmenorrhea* Pain greater than or equal to 3 out of 10 on a numeric rating scale during the first three days of menses for at least two of the past 3 menstrual cycles. * Regular menstrual cycles (28 +/‐ 7 days) for the last three months. * Understands spoken and written English * Able to give informed consent
Epistemonikos ID: e3c8b8593a720307a6c7fa1ce7d78af0dec04428
First added on: Aug 25, 2024