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| [ Print-friendly version ] |
| Efficacy and safety of Acupuncture for Migraine Prophylaxis - a multicenter, randomized, controlled clinical trial |
| ISRCTN | ISRCTN49839714 |
| ClinicalTrials.gov identifier | |
| Public title | Efficacy and safety of Acupuncture for Migraine Prophylaxis - a multicenter, randomized, controlled clinical trial |
| Scientific title | |
| Acronym | AMP |
| Serial number at source | SF-2005-2 |
| Study hypothesis | Acupuncture could be an option to prevent migraine attacks in comparison to standard medicine therapy (flunarizine). |
| Ethics approval | Approved by the Research Ethical Committee of the Beijing Hospital of Traditional Chinese Medicine on 24/05/2007 (ref: 200704) |
| Study design | Multicentre randomised single blind controlled study |
| Countries of recruitment | China |
| Disease/condition/study domain | Migraine |
| Participants - 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 |
| Participants - 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, Parkinson’s disease and other extrapyramidal diseases |
| Anticipated start date | 01/06/2007 |
| Anticipated end date | 30/06/2009 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 140 |
| Interventions |
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. |
| Primary outcome measure(s) |
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 measure(s) |
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. |
| Sources of funding | The Beijing Administration of Traditional Chinese Medicine, Capital Medical Development Research Fund (China) |
| Trial website | |
| Publications | 2009 protocol in http://www.ncbi.nlm.nih.gov/pubmed/19389262 |
| Contact name | Dr Linpeng Wang |
| Address |
No.23 Meishuguanhou Street
Dongcheng District |
| City/town | Beijing |
| Zip/Postcode | 100010 |
| Country | China |
| Sponsor | The Beijing Administration of Traditional Chinese Medicine (China) |
| Address |
No.5 Xiaoqudeng lane
Meishuguanhoujie Dongcheng Districk |
| City/town | Beijing |
| Zip/Postcode | 100010 |
| Country | China |
| Sponsor website: | http://www.bjtcm.gov.cn/index.jsp |
| Date applied | 24/05/2007 |
| Last edited | 20/07/2009 |
| Date ISRCTN assigned | 26/06/2007 |
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