Analgesic effect of acupuncture compared with sham acupuncture in primary dysmenorrhoea: AAEPD-I
| ISRCTN | ISRCTN84496835 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN84496835 |
| Secondary identifying numbers | 2006CB504503 |
- Submission date
- 29/10/2007
- Registration date
- 08/11/2007
- Last edited
- 04/07/2011
- 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
Not provided at time of registration
Contact information
Prof Zhu Jiang
Scientific
Scientific
11 Bei San Huan Dong Lu
Chao Yang District
Beijing
100029
China
| Phone | +86 (0)10 8456 0099 |
|---|---|
| jzhjzh@263.net |
Study information
| Study design | Multicentre randomised controlled clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Analgesic effect of acupuncture compared with sham acupuncture in primary dysmenorrhoea: a multicentre, randomised, controlled clinical trial |
| Study 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(s) | Ethics approval received from the Medical Ethical Committee of the Beijing University of Traditional Chinese Medicine on the 22nd October 2007 (ref: 200710). |
| 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 |
| Primary outcome measure | 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 study start date | 11/11/2007 |
| Overall study end date | 01/10/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 200 |
| 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 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
Study participating centre
11 Bei San Huan Dong Lu
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 |
