Condition category
Urological and Genital Diseases
Date applied
15/11/2008
Date assigned
11/12/2008
Last edited
20/02/2015
Prospective/Retrospective
Retrospectively 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 Jiang Zhu

ORCID ID

Contact details

Beijing University of Chinese Medicine
11 Bei San Huan Dong Lu
Chao Yang District
Beijing
100029
China
+86 (0)10 8456 0099
603005@bucm.edu.cn

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 multi-centre randomised controlled clinical trial-II

Acronym

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

Study hypothesis

Some recent randomised controlled trials (RCTs) suggested that acupuncture was no more effective than sham acupuncture. Because of small sample size in the previous study (50 patients in each arm) (ISRCTN84496835), we have a design for a larger sample of trial to evaluate the point specificity of analgesic effect of acupuncture at SP6 in primary dysmenorrhoea. For the primary outcome measure the Visual Analogue Scale (VAS) score for pain at baseline and 30 minutes after the first intervention, the previous study (ISRCTN84496835) suggested a 47.58% improvement for acupoint group, compared with 40.71% for non-acupoint group. We used these findings as the basis for our power calculation. At 5% significance and 80% power, 145 patients are required in each arm. Taking into consideration a 15% dropout rate, at least 167 patients in each arm are needed.

Ethics approval

Medical Ethics Committee of the Beijing University of Chinese Medicine, approved on 10/11/2008

Study design

Multi-centre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Primary dysmenorrhoea

Intervention

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 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 Applicable

Drug names

Primary outcome measures

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 outcome measures

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)

Overall trial start date

01/12/2008

Overall trial end date

31/12/2009

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 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

501

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
4. They have previously received acupuncture (to maximize blinding)

Recruitment start date

01/12/2008

Recruitment end date

31/12/2009

Locations

Countries of recruitment

China

Trial participating centre

Beijing University of Chinese Medicine
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

2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21166767
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24555788
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24636695

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.

  2. Results

    Shi GX, Li QQ, Liu CZ, Zhu J, Wang LP, Wang J, Han LL, Guan LP, Wu MM, Effect of acupuncture on Deqi traits and pain intensity in primary dysmenorrhea: analysis of data from a larger randomized controlled trial., BMC Complement Altern Med, 2014, 14, 69, doi: 10.1186/1472-6882-14-69.

  3. Results

    Liu CZ, Xie JP, Wang LP, Liu YQ, Song JS, Chen YY, Shi GX, Zhou W, Gao SZ, Li SL, Xing JM, Ma LX, Wang YX, Zhu J, Liu JP, A randomized controlled trial of single point acupuncture in primary dysmenorrhea, Pain Med, 2014 , 15, 6, 910-920, doi: 10.1111/pme.12392.

Additional files

Editorial Notes