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Analgesic effect of acupuncture compared with sham acupuncture in primary dysmenorrhoea: AAEPD-I

Analgesic effect of acupuncture compared with sham acupuncture in primary dysmenorrhoea: a multicentre, randomised, controlled clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN84496835
Enrollment
200
Registered
2007-11-08
Start date
2007-11-11
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary dysmenorrhoea Urological and Genital Diseases Dysmenorrhoea

Interventions

1. Acupuncture 2. Sham acupuncture 3. Waiting list control Acupuncture and sham acupuncture were administered once-daily for 3 days with acupuncture at Sanyinjiao (SP6) that was specifically designed

Sponsors

Ministry of Science and Technology (China)
Lead Sponsor

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 the Visual Analogue Scale (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

Design outcomes

Primary

MeasureTime frame
1. The 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

MeasureTime frame
1. Pain (as measured by VAS score) was also used as a secondary outcome at other time points 2. The changes of assigned analgesic medication usage that each participant reported using, and proportion of participants in each group who were using analgesics in addition to their assigned treatment

Countries

China

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026