Analgesic effect of acupuncture compared with sham acupuncture in primary dysmenorrhoea: AAEPD-II
| ISRCTN | ISRCTN24863192 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN24863192 |
| Secondary identifying numbers | 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
Scientific
Beijing University of Chinese Medicine
11 Bei San Huan Dong Lu
Chao Yang District
Beijing
100029
China
| Phone | +86 (0)10 8456 0099 |
|---|---|
| 603005@bucm.edu.cn |
Study information
| Study design | Multi-centre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 01/12/2008 |
| Completion date | 31/12/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 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
100029
China
Sponsor information
Ministry of Science and Technology (China)
Government
Government
15B
Fuxing Road
Beijing
100862
China
| Phone | +86 (0)10 5888 1072 |
|---|---|
| jcc973@vip.sina.com | |
| Website | http://www.most.gov.cn/eng/index.htm |
"ROR" |
https://ror.org/027s68j25 |
Funders
Funder type
Government
Ministry of Science and Technology (China) - National Basic Research Programme (ref: 2006CB504503)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
