Clinical trial NCT05351918: Comparison of Two Different Migraine Acupuncture Treatment
Official title: Migraine Treatment With Acupuncture: Comparison of Standard Protocol to Meridian Based Protocol
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Migraine
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
First posted: 2022-04-28
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with migrain

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* age \>18 years
* pragnancy

Exclusion Criteria:

* patients refusal

Primary outcomes:
measure: number disabled migraine days
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: UMC Ljubljana
Study officials:
affiliation: UMC LJUBLJANA
name: Jasmina Markovic - Bozic, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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