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Completed

NCT Number: NCT05351918

Comparison of Two Different Migraine Acupuncture Treatment

Headache is one of the most common clinical problems. Conventional drug therapy is more successful when complementary and integrative medicine approaches are combined to conventional treatment, as traditional Chinese medicine (TKM).

The success of acupuncture therapy depends on the selection of acupuncture points according to TKM pathological mechanisms. Correct selection of points are needed to treat migraine headaches.Acupuncture reduces the consumption of analgesics.

In this prospective, randomised study we will compered two methods of acupuncture stimulation: in the control group, all patients will receive the same local points, commonly used to treat migraine in our department, in the study group, local points will be selected according to the site of the headache.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UMC Ljubljana

Ljubljana, 1000, Slovenia

About this study

Headache is one of the most common clinical problems. It is a subjective symptom that can be associated with many other syndromes. Conventional drug therapy is often effective in reducing of acute headache and also in the frequency and intensity of chronic headaches. However, the treatment is even more successful when complementary and integrative medicine approaches are combined to conventional treatment. The most commonly used method is traditional Chinese medicine (TKM).

Although acupuncture has been a key component of TKM for more than 2500 years, the mechanism of action is still not fully understood. Acupuncture needles probably stimulates the delta fibers, and thus the pain stimulus does not occur to the talamus. Acupuncture increases the activity of the opioidergic system by releasing serotonin, dopamine, neurotrophines and nitric oxide, which are effective in treating chronic pain and migraines. Acupuncture has been recognised by the WHO as a method for the treatment of acute and chronic pain. The success of acupuncture therapy depends on the selection of acupuncture points according to TKM pathological mechanisms. Correct selection of points are needed to treat migraine headaches. Local, regional and distal points are used. Acupuncture reduces the consumption of analgesics.

The research will be conducted in the clinical Department of Anaesthesiology and Intensive Care Therapy in University Medical Centre Ljubljana. Patients with migraine headaches will be included in the study. The quality of life after treatment, drug consumption, satisfaction and well-being will be monitored. The research will determine if targeted acupuncture stimulation regard to the location of headache reduces the frequency and severity of migraines compared to the established treatment method, thus reducing the number diabled days. The added value of the research is monitoring the quality of life after completed treatment, drug consumption and in satisfaction and well-being of the patient.

PROTOCOL

60 patients with migraine will be included in this prospective, randomised study, scheduled for acupuncture stimulation. Two methods of acupuncture stimulation will be compared. In all patients, DU 20 point and the same distal points will be used.

  • ALL PATIENTS: DU 20 local points: Ex 1 distal points: LI 4, St 36, Liv 2

In the control group, all patients will receive the same local points, commonly used to treat migraine in our department.

  • CONTROL GROUP: localn points: UB 2; GB 14, 16, 20 distal points: PC 6, SJ 5

In the study group, local points will be selected according to the site of the headache.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age >18 years
  • pragnancy

Exclusion criteria

  • patients refusal

Treatment and study plan

Acupuncture

Other

Acupuncture points are punctured with needles.

Primary outcomes

  1. number disabled migraine days

    Time frame: 6 months

    The quality of life after treatment, drug consumption, satisfaction and well-being will be monitored. The research will determine if targeted acupuncture stimulation regard to the location of headache reduces the frequency and severity of migraines compared to the established treatment method, thus reducing the number diabled days. The added value of the research is monitoring the quality of life after completed treatment, drug consumption and in satisfaction and well-being of the patient.

Sponsors and collaborators

Lead sponsor

University Medical Centre Ljubljana

Other

Registry information

Official study title

Migraine Treatment With Acupuncture: Comparison of Standard Protocol to Meridian Based Protocol

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 28, 2022
Registry last updated
Nov 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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