Primary dysmenorrhoea Urological and Genital Diseases Primary dysmenorrhoea
Conditions
Interventions
1. Acupuncture
2. Sham acupuncture
Acupuncture and sham acupuncture were administered once-daily for 3 days with acupuncture at Sanyinjiao (SP6) that was specifically designed to treat primary dysm
Sponsors
Ministry of Science and Technology (China)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Women aged 18 to 30 years 2. A history of regular menstruation (28-day cycle +/- 7 days) 3. Primary dysmenorrhoea (onset greater than or equal to 3 years after menarche) 4. Menstrual cramping pain of moderate or severe intensity, varying from 4.0 to 10.0 on VAS, and for at least 6 months before study entry 5. Not pregnant 6. Good general health 7. Agree to refrain from the use of any analgesics 24 hours before the first intervention 8. Provide written informed consent prior to enrolment
Exclusion criteria
Exclusion criteria: 1. Dysmenorrhoea secondary to organic pathology 2. A history of term pregnancy or possible current pregnancy 3. Severe gastrointestinal, gynaecological or autoimmune diseases, or gynaecological surgery 4. They have previously received acupuncture (to maximize blinding)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. VAS score for pain at baseline, 5, 10, 30, and 60 minutes after the first intervention 2. Cox Retrospective Symptom Scale (RSS) during 3 menstrual cycles (before the treatment, during the treatment, and in 1 subsequent cycle after intervention) 3. Verbal Rating Scale (VRS) during 3 menstrual cycles (before the treatment, during the treatment, and in 1 subsequent cycle after intervention) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Pain, as measured by VAS, before the second intervention, before the third intervention, and during 3 menstrual cycles 2. The changes in assigned analgesic medication usage that each participant reported using during 2 menstrual cycles (during the treatment and in 1 subsequent cycle after intervention), and proportion of participants in each group who were using analgesics in addition to their assigned treatment during 2 menstrual cycles (during the treatment and in 1 subsequent cycle after intervention) | — |
Countries
China
Outcome results
None listed