Condition category
Urological and Genital Diseases
Date applied
29/10/2007
Date assigned
08/11/2007
Last edited
04/07/2011
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Zhu Jiang

ORCID ID

Contact details

11 Bei San Huan Dong Lu
Chao Yang District
Beijing
100029
China
+86 (0)10 8456 0099
jzhjzh@263.net

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2006CB504503

Study information

Scientific title

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

Acronym

AAEPD-I (Acupuncture Analgesia Effect in Primary Dysmenorrhoea-I)

Study hypothesis

Some recent Randomised Controlled Trials (RCTs) suggested that acupuncture was no more effective than sham acupuncture. Traditional Chinese medicine uses acupuncture of acupoint Sanyinjiao (SP6) to relieve pain of primary dysmenorrhoea. The present trial was to evaluate the point specificity of analgesia effect of acupuncture at SP6 in primary dysmenorrhoea.

A related trial "Analgesic effect of acupuncture compared with sham acupuncture in primary dysmenorrhoea: AAEPD-II" is registered with ISRCTN24863192.

Ethics approval

Ethics approval received from the Medical Ethical Committee of the Beijing University of Traditional Chinese Medicine on the 22nd October 2007 (ref: 200710).

Study design

Multicentre randomised controlled clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Primary dysmenorrhoea

Intervention

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 to treat primary dysmenorrhoea, or 1 of 2 sham acupuncture treatments: acupuncture for an unrelated acupoint (Xuanzhong, GB39), or needle insertion at non-acupoint locations (lateral side of lower leg, 3 inches above the tip of external malleolus, 1.5 inches behind anterior crest of the bibia).

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

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 outcome measures

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

Overall trial start date

11/11/2007

Overall trial end date

01/10/2008

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

200

Participant 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

Recruitment start date

11/11/2007

Recruitment end date

01/10/2008

Locations

Countries of recruitment

China

Trial participating centre

11 Bei San Huan Dong Lu
Beijing
100029
China

Sponsor information

Organisation

Ministry of Science and Technology (China)

Sponsor details

15B
Fuxing Road
Beijing
100862
China
+86 (0)10 5888 1072
jcc973@vip.sina.com

Sponsor type

Government

Website

http://www.most.gov.cn/eng/index.htm

Funders

Funder type

Government

Funder name

Ministry of Science and Technology (China) - National Basic Research Programme (ref: 2006CB504503)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21166767

Publication citations

  1. Results

    Liu CZ, Xie JP, Wang LP, Zheng YY, Ma ZB, Yang H, Chen X, Shi GX, Li SL, Zhao JP, Han JX, Li JD, Wang YX, Tang L, Xue XO, Li M, Wang Y, Sun AP, Xing JM, Cao HJ, Zhu J, Liu JP, Immediate analgesia effect of single point acupuncture in primary dysmenorrhea: a randomized controlled trial., Pain Med, 2011, 12, 2, 300-307, doi: 10.1111/j.1526-4637.2010.01017.x.

Additional files

Editorial Notes