A clinical trial of acupuncture as prophylaxis for Menstrually Related Migraine (MRM)

Not Applicable

Completed

• Conditions: Menstrually related migraine (MRM); Acupuncture; Prophylaxis treatment; Mental and Behavioural Disorders; Migraine

• Registration Number: ISRCTN57133712
• Lead Sponsor: Beijing Municipal Science and Technology Commission (China)

Brief Summary

2013 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/24195839 protocol 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36090267/ (added 13/09/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-12-19
• Study Completion: 2013-12-30
• Last Update Posted: 26 September 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 170

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. The change of migraine days inside the menstrual cycle<br> 2. The proportion of responders (defined as the proportion of patients with at least a 50% reduction in the number of menstrual migraine days)<br><br> Recording headache diaries for four continuous menstrual cycles that included three months (consecutive menstrual cycles) during treatment and one month (menstrual cycle) after treatment.<br><br> All assessments will be conducted at the baseline and at week 12 and 16 follow-up.<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. The change of migraine days outside the menstrual cycle<br> 2. Duration of migraine attack<br> 3. Visual analogue scale (VAS, 0 to 10 cm) for pain<br> 4. Amount of migraine medication used<br><br> Recording headache diaries for four continuous menstrual cycles that included three months (consecutive menstrual cycles) during treatment and one month (menstrual cycle) after treatment.<br><br> All assessments will be conducted at the baseline and at week 12 and 16 follow-up.<br>