Participants are wanted for an acupuncture project against menstrual migraines

What is the background of the study?

Menstrual migraine is a common form of migraine that affects over 50% of female migraine sufferers. Menstrual migraine attacks are generally more painful, last longer, are more prone to recurrence and are more difficult to treat. It is associated with significantly reduced functional capacity, which can lead to reduced quality of life and absence from work. Every year, migraine costs DKK 420 million. DKK in processing and DKK 1.2 billion DKK in lost production in Denmark. It is unbearable and very stressful for both patients and society.

There are a number of studies which show that acupuncture can be a promising treatment for menstrual migraine.

What is the purpose of this study?

The project aim is to investigate whether classical acupuncture methods Ling Gui Ba Fa have a positive effect in the treatment of menstrual migraine.

Ling Gui Ba Fa refers to a type of special acupuncture method, namely time-based acupuncture, which is a system of selecting acupuncture points based on the cycle of the year, month, day and hour. It is also called chrono-acupuncture.

According to David Twicken, treatment at the right time has a powerful influence on the vital substances, which can lead to optimal treatment results.

What is the treatment method?

The treatment in this study used onlyacupuncture.

Who can participate in this study?

You are eligible to participate if you meet the following criteria:

are between 18-55 years of age
diagnosed with menstrual migraine without aura
have a regular menstrual cycle (25-35 days)
know the menstrual date
experiencing at least 1 seizure per month in the past 3 months, no treatment with other methods or treatment stopped for more than 2 months
are willing to give written informed consent and are willing to complete questionnaires and migraine diary
have the opportunity to receive treatment 2 times a week and 5 times in total. Start immediately after a menstrual period in November or December 2022, possibly also in January 2023.

You are not suitable to participate in the study if any of the following apply to you:

is pregnant
have relatively severe systemic diseases in the cardiovascular, hepatic, renal and hematopoietic systems
have plans to switch to a new medication or receive other related treatment during the research treatment that interferes with the observation

What are the possible benefits of participating in this study?

The collected data will be able to shed light on whether this treatment method is beneficial in relation to the relief of menstrual migraine.

If it turns out that the method has a positive effect, the treatment will be offered in the clinic for the benefit of others who suffer from migraines.

Are there any risks involved in participating in this study?

Yes. There may be side effects to treatment with acupuncture. Possible side effects include soreness, minor bleeding or bruising, dizziness, fatigue. But usually of very short duration. Read more aboutacupuncture side effect here.

In the processing of your data and answers, we will at all times comply with the GDPR and if data from this survey is published, all data will be anonymized and no one other than the team behind the survey will know who you are.

What should I do if I would like to participate in the study?

You must be suitable to participate and be willing to answer the questionnaires and migraine diary and show up for the agreed treatments.

When you have read this through, you must reply as soon as possible by email if you would like to participate. If you have any questions before submitting your answer, you are very welcome to send an email.

What happens to the information I provide?

• The collected data will be stored securely on google drive and therapist booking, which is password protected.
When data is processed and must be published, the data will be anonymized and will be stored on Google Drive, which is an online service where it is possible to store data and documents securely.
• Data from the survey will be handled, stored and processed securely and it will be stored for five years before being destroyed.

Who has reviewed the survey?

Acupuncture Academyhas approved this project study.

I want to participate, what do I do now?

If you wish to participate, please send an e-mail as soon as possible toprojekt@akupeng.dk You will automatically receive a questionnaire that I will ask you to complete online.

Should you have any questions about the project, need more information or are unsure whether you are suitable, do not hesitate to send me an emailprojekt@akupeng.dk

Thank you for your interest in the project.

Best regards,
Yuan Peng
Acupuncture Acupuncture & Massage
Mail:projekt@akupeng.dk