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| [ Print-friendly version ] |
| A clinical trial of acupuncture as prophylaxis for Menstrually Related Migraine (MRM) |
| ISRCTN | ISRCTN57133712 |
| DOI | 10.1186/ISRCTN57133712 |
| ClinicalTrials.gov identifier | |
| EudraCT number | |
| Public title | A clinical trial of acupuncture as prophylaxis for Menstrually Related Migraine (MRM) |
| Scientific title | To assess the therapeutic effects on acupuncture as prophylaxis for menstrually related migraine: a multicentre randomised controlled trial |
| Acronym | MRM |
| Serial number at source | JJ2011-03 |
| Study hypothesis | Pre-clinical trials have shown that acupuncture is effective in treating migraine, especially for the prevention of migraine. This study is to verify the efficacy of acupuncture as prophylaxis for MRM. |
| Lay summary | Lay summary under review 2 |
| Ethics approval | Beijing Hospital of Traditional Chinese Medicine Research Ethical Committee, 10 May 2012 ref: 201212 |
| Study design | Multicenter single blind randomized controlled clinical trial |
| Countries of recruitment | China |
| Disease/condition/study domain | Menstrually related migraine (MRM); Acupuncture; Prophylaxis treatment |
| Participants - inclusion criteria |
1. Patients who met diagnostic criteria for menstrually related migraine (International Headache Society Classification of Menstrually Related Migraine, 2nd edn, 2004)
2. Regular menstrual cycle lasting 30±10 days 3. Be able to predict the cycle and the onset period of menstrual related migraine 4. Patients suffered a repeated migraine attacks, frequency of non-menstrual migraine is more than once a month 5. Effective contraception and no plan to become pregnant during the study 6. Patients who took part in the trial voluntarily and signed the informed consent form |
| Participants - exclusion criteria |
1. Patients who are diagnosed as chronic migraine(headache caused by drug abuse is included), tension-type headache, cluster headache, algopsychalia tension-type headache, cluster headache, other primary headache disorders
2. Patients suffered relatively severe systemic disease, such as cardiovascular diseases, acute infectious disease, hematopathy, endocrinopathy, allergy and methysis 3. Patients suffered otorhinolaryngology diseases which may cause headache, such as glaucoma, otitis, sinusitis, pericoronitis of wisdom tooth 4. Patients who suffered headache caused by intracranial pathological changes, such as intracranial infection, brain tumours, subarachnoid hemorrhage 5. The blood pressure is not controlled ideally 6. The menses cycle is erratical because of polycystic ovary and other gynecologic diseases, and the time of which is hard to predict 7. Patients who have been taking contraceptives or accepting other hormone therapy during the last 3 months |
| Anticipated start date | 30/12/2011 |
| Anticipated end date | 30/12/2013 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use contact Prof Lin-Peng Wang (wlp5558@sina.com) to request a patient information sheet. |
| Target number of participants | 184 |
| Interventions |
A total of 184 patients are randomly divided into two different groups:
1. Treatment group: Acupuncture (preventive treatment on migraine and premenstrual conditioning) and placebo medicine 2. Control group: Sham acupuncture and medicine (Naproxen Sustained Release Tablets) Patients in both groups are asked to receive acupuncture twice a week, each session lasts for 30 min. Both Naproxen and placebo are taken 0.5g once per day, from the third day (±1 day accepted) before menstruation comes to the end of menstruation period. All treatments are administered for three months (consecutive menstrual cycles). |
| Primary outcome measure(s) |
1. The change of migraine days inside the menstrual cycle
2. The proportion of responders (defined as the proportion of patients with at least a 50% reduction in the number of menstrual migraine days) Recording headache diaries for four continuous menstrual cycles that included three months (consecutive menstrual cycles) during treatment and one month (menstrual cycle) after treatment. All assessments will be conducted at the baseline and at week 12 and 16 follow-up. |
| Secondary outcome measure(s) |
1. The change of migraine days outside the menstrual cycle
2. Duration of migraine attack 3. Visual analogue scale (VAS,0 to 10 cm) for pain 4. Amount of migraine medication used Recording headache diaries for four continuous menstrual cycles that included three months (consecutive menstrual cycles) during treatment and one month (menstrual cycle) after treatment. All assessments will be conducted at the baseline and at week 12 and 16 follow-up. |
| Sources of funding |
Beijing Municipal Science and Technology Commission (China)
Beijing Hospital of Traditional Chinese Medicine (China) |
| Trial website | |
| Publications | |
| Contact name | Prof Lin-Peng Wang |
| Address |
Beijing Hospital of Traditional Chinese Medicine
No.23 Meishuguanhou Street Dongcheng District |
| City/town | Beijing |
| Zip/Postcode | 100010 |
| Country | China |
| Tel | +86 (0)10 5217 6636 |
| Fax | +86 (0)10 5217 6808 |
| wlp5558@sina.com | |
| Sponsor | Beijing Municipal Science and Technology Commission (China) |
| Address |
No. 16 Xizhimendajie
Xicheng Dis |
| City/town | Beijing |
| Zip/Postcode | 100035 |
| Country | China |
| Tel | +86 (0)10 6615 3395 |
| bjkwwz@sina.com | |
| Sponsor website: | http://www.bjkw.gov.cn/n1143/index.html |
| Date applied | 29/11/2012 |
| Last edited | 04/02/2013 |
| Date ISRCTN assigned | 19/12/2012 |
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| © 2013 ISRCTN unless otherwise stated. | |
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