None listed
Conditions
Brief summary
Primary Dysmenorrhea (PD) is the most common gynaecological complaint in menstruating women with over 75% of women suffering at some stage during their reproductive years. Common symptoms of PD are cramping lower abdominal pain, nausea, vomiting, headache and lower back pain. Women who suffer from regular PD are more likely to have work or school absence as well as lower quality of life and increased risk of psychological and chronic pain related disorders. Pragmatic trials of acupuncture have shown a reduction in pain and an improvement in quality of life in women with PD. However to date there has been scant evidence for how changing the 'dosage' of acupuncture would affect the outcome in women with PD. The primary aim of this project is to examine the affect of changing frequency and type of stimulation on the symptoms of primary dysmenorrhea. To achieve this a 4 group randomised controlled trial will be used. Women will be given individualised acupuncture treatments based on their group allocation; high frequency manual acupuncture, low frequency manual acupuncture, high frequency electro acupuncture and low frequency electro acupuncture. Treatment will be given for three menstrual cycles and the primary outcome is a reduction in peak menstrual pain. Participants in the trial will be invited to participate in an interview to share their experiences.
Interventions
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 th
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.
Sponsors
University of Western Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Factorial
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator)
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
No
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
Exclusion criteria
* Previous diagnosis of endometriosis or secondary dysmenorrhea. * Abdominal Surgery in the previous 3 months * Injectable or implant contraceptives (Depo provera, Jadelle, Murina ) within the last 3 months * Oral Contraceptive usage started less than 3 months ago * Chronic pain conditions ( >14 days per month with pain) * Current mental health illness * Neuropathic pain secondary to surgery * Sterilisation
Outcome results
None listed