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

• Register: ISRCTN
• Last refreshed on: 26 September 2022
• Main ID: ISRCTN57133712
• Date of registration: 19/12/2012
• Prospective Registration: No
• Primary sponsor: Beijing Municipal Science and Technology Commission (China)
• 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
• Date of first enrolment: 30/12/2011
• Target sample size: 184
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN57133712
• Study type: Interventional
• Study design: Multicenter single-blind randomized controlled clinical trial (Treatment)
• Phase: Not Applicable

Countries of recruitment

China

Contacts

• Name: Lin-Peng Wang

Key inclusion & exclusion criteria

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


Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

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

Intervention(s)

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 0.5 g once per day, from the third day (±1 day accepted) before menstruation comes to the end of menstruation period.

All treatments are administered for 3 months (consecutive menstrual cycles).

Primary Outcome(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(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.

Secondary ID(s)

JJ2011-03

Source(s) of Monetary Support

Beijing Municipal Science and Technology Commission (China), Beijing Hospital of Traditional Chinese Medicine (China)

Ethics review

Status:
Approval date:
Contact:

Beijing Hospital of Traditional Chinese Medicine Research Ethical Committee, 10/05/2012, ref: 201212

Results

• Results available: Yes
• Date Completed: 30/12/2013