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

ISRCTN	ISRCTN24863192
DOI	https://doi.org/10.1186/ISRCTN24863192
Protocol serial number	2006CB504503
Sponsor	Ministry of Science and Technology (China)
Funder	Ministry of Science and Technology (China) - National Basic Research Programme (ref: 2006CB504503)

Submission date: 15/11/2008
Registration date: 11/12/2008
Last edited: 20/02/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Urological and Genital Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Jiang Zhu
Scientific

Beijing University of Chinese Medicine
11 Bei San Huan Dong Lu
Chao Yang District
Beijing
100029
China

Phone	+86 (0)10 8456 0099
Email	603005@bucm.edu.cn

Study information

Primary study design	Interventional
Study design	Multi-centre randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Analgesic effect of acupuncture compared with sham acupuncture in primary dysmenorrhoea: a multi-centre randomised controlled clinical trial-II
Study acronym	AAEPD-II (Acupuncture Analgesia Effect in Primary Dysmenorrhoea-II)
Study objectives	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(s)	Medical Ethics Committee of the Beijing University of Chinese Medicine, approved on 10/11/2008
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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)
Key secondary outcome measure(s)	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)
Completion date	31/12/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target sample size at registration	501
Key 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
Key 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)
Date of first enrolment	01/12/2008
Date of final enrolment	31/12/2009

Locations

Countries of recruitment

China

Study participating centre

Beijing University of Chinese Medicine

Beijing
100029
China

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/02/2011		Yes	No
Results article	results	21/02/2014		Yes	No
Results article	results	01/06/2014		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes