Condition category
Mental and Behavioural Disorders
Date applied
29/11/2012
Date assigned
19/12/2012
Last edited
14/05/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Migraine is a condition that causes attacks of headaches, and often other symptoms such as feeling sick or being sick. When migraine attacks occur during periods this is called menstrually related migraine (MRM). About 6 in 10 women who have migraine have this type of pattern. This aim of this study is to test the effectiveness of acupuncture for the treatment of MRM. Acupuncture is a treatment derived from ancient Chinese medicine in which fine needles are inserted at certain sites in the body.

Who can participate?
Women with menstrually related migraine.

What does the study involve?
Patients will be randomly divided into two different groups. One group will be treated with acupuncture and a placebo (dummy) medicine while the other group will be treated with sham acupuncture and naproxen tablets. All treatments are administered for 3 months. Patients will record their headaches in a diary for the 3 months during treatment and one month after treatment. Assessments will be conducted at the start of the study and at follow-up weeks 12 and 16.

What are the possible benefits and risks of participating?
The treatment may reduce the frequency and intensity of headaches. Possible risks include discomfort or bruising at the sites of needle insertion, feeling sick, or feeling faint after each treatment.

Where is the study run from?
Beijing Traditional Chinese Medical Hospital affiliated with Capital Medical University, the Third Hospital of Peking University, Beijing Tiantan Hospital affiliated with Capital Medical University, and Xiyuan Hospital affiliated with China Academy of the Chinese Medical Sciences (CACMS).

When is the study starting and how long is it expected to run for?
This study started in December 2011 and is expected to run for two years.

Who is funding the study?
1. Beijing Municipal Science and Technology
2. Commission (China) Beijing Hospital of Traditional Chinese Medicine (China)

Who is the main contact?
Prof Lingpeng Wang
wlp5558@sina.com

Trial website

Contact information

Type

Scientific

Primary contact

Prof Lin-Peng Wang

ORCID ID

Contact details

Beijing Hospital of Traditional Chinese Medicine
No.23 Meishuguanhou Street
Dongcheng District
Beijing
100010
China
+86 (0)10 5217 6636
wlp5558@sina.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

JJ2011-03

Study information

Scientific title

To assess the therapeutic effects on acupuncture as prophylaxis for menstrually related migraine: a multicentre randomised controlled trial

Acronym

MRM

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.

Ethics approval

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

Study design

Multicenter single-blind randomized controlled clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact Prof Lin-Peng Wang (wlp5558@sina.com) to request a patient information sheet.

Condition

Menstrually related migraine (MRM); Acupuncture; Prophylaxis treatment

Intervention

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).

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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 measures

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.

Overall trial start date

30/12/2011

Overall trial end date

30/12/2013

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

184

Participant 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

Recruitment start date

30/12/2011

Recruitment end date

30/12/2013

Locations

Countries of recruitment

China

Trial participating centre

Beijing Traditional Chinese Medical Hospital affiliated with Capital Medical University
China

Trial participating centre

Third Hospital of Peking University
China

Trial participating centre

Beijing Tiantan Hospital affiliated with Capital Medical University
China

Trial participating centre

Xiyuan Hospital affiliated with China Academy of the Chinese Medical Sciences
China

Sponsor information

Organisation

Beijing Municipal Science and Technology Commission (China)

Sponsor details

No. 16 Xizhimendajie
Xicheng Dis
Beijing
100035
China
+86 (0)10 6615 3395
bjkwwz@sina.com

Sponsor type

Government

Website

http://www.bjkw.gov.cn/n1143/index.html

Funders

Funder type

Government

Funder name

Beijing Municipal Science and Technology Commission (China)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Beijing Hospital of Traditional Chinese Medicine (China)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24195839

Publication citations

  1. Protocol

    Zhang XZ, Zhang L, Guo J, Zeng L, Yang Y, Zhang T, Shi GX, Liu HL, Wang LP, Acupuncture as prophylaxis for menstrual-related migraine: study protocol for a multicenter randomized controlled trial., Trials, 2013, 14, 374, doi: 10.1186/1745-6215-14-374.

Additional files

Editorial Notes