Efficacy and safety of Acupuncture for Migraine Prophylaxis - a multicenter, randomized, controlled clinical trial
| ISRCTN | ISRCTN49839714 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN49839714 |
| Secondary identifying numbers | SF-2005-2 |
- Submission date
- 24/05/2007
- Registration date
- 26/06/2007
- Last edited
- 11/07/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Linpeng Wang
Scientific
Scientific
No.23 Meishuguanhou Street
Dongcheng District
Beijing
100010
China
Study information
| Study design | Multicentre randomised single blind controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | Efficacy and safety of Acupuncture for Migraine Prophylaxis - a multicenter, randomized, controlled clinical trial |
| Study acronym | AMP |
| Study objectives | Acupuncture could be an option to prevent migraine attacks in comparison to standard medicine therapy (flunarizine). |
| Ethics approval(s) | Approved by the Research Ethical Committee of the Beijing Hospital of Traditional Chinese Medicine on 24/05/2007 (ref: 200704) |
| Health condition(s) or problem(s) studied | Migraine |
| Intervention | The 140 migraine sufferers are randomly allocated to two different groups: 1. Treatment group: At least three acupuncture sessions per week and placebo medicine once a day for 4 weeks. 2. Control group: At least three sham-acupuncture sessions per week and medicine (flunarizine) once a day for 4 weeks. The patients are asked to receive acupuncture 3 times a week. However, those who require will receive extra acupuncture sessions. Each acupuncture session lasts for 30 min. The dose of flunarizine / placebo is 10 mg per day for 2 weeks and 5 mg per day in the next 2 weeks. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | flunarizine |
| Primary outcome measure | The efficacy of acupuncture for migraine prophylaxis was assessed by the following: 1. Visual Analogue Scale (VAS) to assess the severity of migraine pain 2. Short-From of McGill Pain Questionnaire (SF-MPQ) 3. Change in frequency and duration of migraine attacks The outcome measures above will be assessed before the treatment, at 1 week, 2 and 4 weeks during the treatment, and then every month for 3 months. If necessary, the assessments will be repeated 6 months after the treatment. |
| Secondary outcome measures | 1. Intake of acute-medication 2. Severity of adverse effects 3. Change in the frequency of nausea, vomiting and other correlative symptoms The outcome measures above will be assessed before the treatment, at 1 week, 2 and 4 weeks during the treatment, and then every month for 3 months. If necessary, the assessments will be repeated 6 months after the treatment. |
| Overall study start date | 01/06/2007 |
| Completion date | 30/06/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 140 |
| Total final enrolment | 140 |
| Key inclusion criteria | 1. Patients suffering from migraine without frequent aura (more than 2 migraine attacks in 4 weeks), diagnosed according to criteria of the International Headache Society 2. Male or female 3. Aged 18-65 years 4. Patients who had not used acupuncture or drugs with migraine prophylactic effects within the last 3 months |
| Key exclusion criteria | 1.Tension-type headache, Cluster headache and other primary headaches 2. Secondary headache and other neurological diseases 3. Neuralgia of the face or head 4. Pregnancy, nursing mother or insufficient contraception 5. Use of prophylactic migraine medication in the last 3 months 6. Therapy with beta-blocker in the last 3 months 7. Intake of antipsychotic or antidepressant drugs 8. Participation in another clinical trial 9. Have family history of depression, Parkinsons disease and other extrapyramidal diseases |
| Date of first enrolment | 01/06/2007 |
| Date of final enrolment | 30/06/2009 |
Locations
Countries of recruitment
- China
Study participating centre
No.23 Meishuguanhou Street
Beijing
100010
China
100010
China
Sponsor information
The Beijing Administration of Traditional Chinese Medicine (China)
Government
Government
No.5 Xiaoqudeng lane
Meishuguanhoujie
Dongcheng Districk
Beijing
100010
China
| Website | http://www.bjtcm.gov.cn/index.jsp |
|---|---|
"ROR" |
https://ror.org/05damtm70 |
Funders
Funder type
Government
The Beijing Administration of Traditional Chinese Medicine, Capital Medical Development Research Fund (China)
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? |
|---|---|---|---|---|---|
| Protocol article | protocol | 24/04/2009 | Yes | No | |
| Results article | results | 01/08/2011 | 11/07/2019 | Yes | No |
Editorial Notes
11/07/2019: Publication reference and total final enrolment added.
