The Impact of Acupuncture on Biomarkers of Brain Injury and Inflammatory Response in Migraine (ACUPMIGRAINE)

University Medical Centre Ljubljana

Status: Active, not recruiting

Conditions: Migraine in Adults; Migraine Headache; Migraine; Migraine Headache, With or Without Aura

Treatments: Other: Laser Acupuncture; Other: Electroacupuncture; Other: Standard acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT07292506

0120-319/2024-2711-6

Details and patient eligibility

About

Migraine is more than just a headache-it can involve changes in the brain and inflammation. Recent research suggests that acupuncture may help by calming pain signals and reducing inflammation in the body. Scientists are studying whether acupuncture can also lower certain markers in the blood that show brain stress or inflammation. While more research is needed, acupuncture is considered safe and may reduce the number and severity of migraine attacks for many people. Acupuncture has been used for over 40 years in our practice to manage acute and chronic pain, including migraines. When performed by trained physicians, it is safe and typically reduces headache frequency and intensity, as well as nausea and vomiting, lowering the need for pain medication.

Investigators are exploring three different ways to help manage migraine headaches using gentle stimulation techniques. These include laser acupuncture, electroacupuncture, and traditional acupuncture.

Investigators want to see which method works best for reducing migraine symptoms. Investigators will look at how participants feel after treatment and also check blood samples for signs of inflammation and certain substances linked to migraines, such as calcitonin gene-related peptide (CGRP) and markers of brain stress.

Investigators have a goal to find safe and effective options that can improve migraine care and help people feel better.

Full description

Investigators are conducting a study to compare three different types of acupuncture treatments. Each participant will be carefully evaluated to meet the requirements for participation. Before joining, each participant will have a conversation with investigators to explain the study and answer any questions.

Participants will be randomly placed into one of three groups:

Traditional Acupuncture - standard acupuncture treatment Electroacupuncture - standard acupuncture combined with gentle electrical stimulation.

Laser Acupuncture - standard acupuncture combined with acupuncture using a low-level laser instead of needles.

After the treatment, Investigators will check in with participants again after 1 and 3 months to see how they are feeling and whether the effects have lasted.Participation is voluntary, with no financial compensation, and care will not be affected by the decision to participate.

Outcomes will be assessed using questionnaires before treatment and for three months afterward, measuring migraine days, pain intensity, medication use, headache frequency, and satisfaction of participants. Blood samples will be collected at baseline, after treatment, and three months later to analyze migraine-related biomarkers. Results will be statistically evaluated. Investigators expect acupuncture to reduce headache severity and medication use.

So far, there has been no direct comparison of these three methods. Investigators want to find out:

Which method works best. How long the benefits last. Whether participants need repeat treatments.

Enrollment: 75 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Adults diagnosed with migraine headaches according to the International Classification of Headache Disorders (ICHD).
• Patients who are not currently receiving monoclonal antibodies targeting CGRP (Calcitonin Gene-Related Peptide)
• Ability to provide informed consent and comply with study procedures. Exclusion Criteria
• Use of CGRP monoclonal antibody therapy within the past 6 months.
• Other significant neurological or systemic conditions that could interfere with study outcomes.
• Pregnancy or breastfeeding.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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75 participants in 3 patient groups

Standard acupuncture

Active Comparator group

Description:

Traditional Acupuncture - standard acupuncture treatment on local scalp and distal points

Treatment:

Other: Standard acupuncture

Electroacupuncture

Active Comparator group

Description:

Electroacupuncture - standard acupuncture on local scalp points combined with gentle electrical stimulation of the needles placed on distal points

Treatment:

Other: Standard acupuncture

Other: Electroacupuncture

Laser Acupuncture

Active Comparator group

Description:

Laser Acupuncture - standard acupuncture on local scalp points combined with low-level laser instead of needles on distal acupuncture points

Treatment:

Other: Standard acupuncture

Other: Laser Acupuncture