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

NCT ID: NCT07292506

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-03

Study Completion Date

2026-07-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Migraine Migraine Headache Migraine Headache, With or Without Aura Migraine in Adults

Keywords

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electroacupuncture migraine acupuncture biomarkers of brain injury inflammatory response laser acupuncture traditional acupuncture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomly placed into one of three groups:

Traditional Acupuncture - standard acupuncture treatment on local scalp and distal points Electroacupuncture - standard acupuncture on local scalp points combined with gentle electrical stimulation of the needles placed on distal points Laser Acupuncture - standard acupuncture on local scalp points combined with low-level laser instead of needles on distal acupuncture points
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard acupuncture

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

Group Type ACTIVE_COMPARATOR

Standard acupuncture

Intervention Type OTHER

standard acupuncture on the scalp and distal acupuncture point that will not be stimulated with electro or laser device

Electroacupuncture

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

Group Type ACTIVE_COMPARATOR

Standard acupuncture

Intervention Type OTHER

standard acupuncture on the scalp and distal acupuncture point that will not be stimulated with electro or laser device

Electroacupuncture

Intervention Type OTHER

Electroacupuncture - distal acupuncture points will be stimulated will electronic device that is used for electroacupuncture

Laser Acupuncture

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

Group Type ACTIVE_COMPARATOR

Standard acupuncture

Intervention Type OTHER

standard acupuncture on the scalp and distal acupuncture point that will not be stimulated with electro or laser device

Laser Acupuncture

Intervention Type OTHER

Distal acupuncture points will be stimulated with laser needles

Interventions

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Standard acupuncture

standard acupuncture on the scalp and distal acupuncture point that will not be stimulated with electro or laser device

Intervention Type OTHER

Electroacupuncture

Electroacupuncture - distal acupuncture points will be stimulated will electronic device that is used for electroacupuncture

Intervention Type OTHER

Laser Acupuncture

Distal acupuncture points will be stimulated with laser needles

Intervention Type OTHER

Eligibility Criteria

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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)

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Medical Centre Ljubljana

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lea Rupert, MD

Role: PRINCIPAL_INVESTIGATOR

Clinical department of anaesthesiology and surgical intensive therapy University Medical Centre Ljubljana

Jasmina Markovic Bozic, MD, Phd, Asist. Prof.

Role: STUDY_CHAIR

Clinical department of anaesthesiology and surgical intensive therapy University Medical Centre Ljubljana

Locations

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Clinical department of anaesthesiology and surgical intensive therapy University Medical Centre Ljubljana

Ljubljana, , Slovenia

Site Status

Countries

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Slovenia

References

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Xu S, Yu L, Luo X, Wang M, Chen G, Zhang Q, Liu W, Zhou Z, Song J, Jing H, Huang G, Liang F, Wang H, Wang W. Manual acupuncture versus sham acupuncture and usual care for prophylaxis of episodic migraine without aura: multicentre, randomised clinical trial. BMJ. 2020 Mar 25;368:m697. doi: 10.1136/bmj.m697.

Reference Type RESULT
PMID: 32213509 (View on PubMed)

Liu Y, Yu S. Recent Approaches and Development of Acupuncture on Chronic Daily Headache. Curr Pain Headache Rep. 2016 Jan;20(1):4. doi: 10.1007/s11916-015-0535-7.

Reference Type RESULT
PMID: 26700695 (View on PubMed)

Peters GL. Migraine overview and summary of current and emerging treatment options. Am J Manag Care. 2019 Jan;25(2 Suppl):S23-S34.

Reference Type RESULT
PMID: 30681821 (View on PubMed)

Other Identifiers

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0120-319/2024-2711-6

Identifier Type: -

Identifier Source: org_study_id