Acupuncture as Migraine Prophylaxis in Reducing Frequency, Duration and Intensity of Migraine With Minimum Acupoint, Seen up to Eight Weeks From Baseline

NCT ID: NCT04509141

Last Updated: 2020-08-11

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

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-05

Study Completion Date

2019-08-30

Brief Summary

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Migraine is a primary headache attack, specific, paroxysmal, with or without aura, with subjective manifestations both before and after the attack, a chronic type of headache with symptoms of recurrence, attacks at productive age and can cause a decrease in work productivity up to 80%, so that it will affect the quality of life, economic life and education globally which leads to losses for migraine sufferers and institutions where migraine sufferers attend school, work and in the lives of sufferers' families.

Detailed Description

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Migraine is a primary headache attack, specific, paroxysmal, with or without aura, with subjective manifestations both before and after the attack, a chronic type of headache with symptoms of recurrence, attacks at productive age and can cause a decrease in work productivity up to 80%, so that it will affect the quality of life, economic life and education globally which leads to losses for migraine sufferers and institutions where migraine sufferers attend school, work and in the lives of sufferers' families. With the high prevalence and disability rates for migraine sufferers, on the other hand, the right treatment for migraine has not yet been obtained to the maximum, it is necessary to deepen the treatment and prevention of migraine is needed, and until now there has been no definitive cure, both for prevention and treatment, so it is necessary to develop therapies that can provide more accurate relief for migraine sufferers. The purpose of this study is to assess the success in managing migraine in reducing the frequency of attacks, reducing the intensity of attacks and reducing the duration of attacks from weeks 0, 4 to 8

Conditions

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Migraine Headache Migraine Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A randomized controlled trial with control was conducted on 34 subjects with migraine who were randomly allocated into the manual group of acupuncture (n = 17), as well as the medicine group (n = 17). The assessment of frequency, duration and intensity of migraine attacks assessed at the time before treatment, at the fourth and eight week from baseline
Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors
the patient did not know that there were two groups divided in each participants, and the doctor who measures the outcome also did not know which person belongs to which group

Study Groups

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acupuncture

acupuncture three times a week

Group Type ACTIVE_COMPARATOR

acupuncture

Intervention Type OTHER

acupuncture points used were EXHN5 Taiyang, GB20 Fengchi, TE5 Waigun, GB41 Zulinqi

standard treatment for migraine by neurologist

standard treatment for migraine that was given by a neurologist

Group Type ACTIVE_COMPARATOR

acupuncture

Intervention Type OTHER

acupuncture points used were EXHN5 Taiyang, GB20 Fengchi, TE5 Waigun, GB41 Zulinqi

Interventions

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acupuncture

acupuncture points used were EXHN5 Taiyang, GB20 Fengchi, TE5 Waigun, GB41 Zulinqi

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* subjects aged 19-50 years
* subjects with history of clinical diagnosis of migraine (interictal period)
* signed research approval forms, and were willing to take the study to completion.

Exclusion Criteria

* subjects with pregnancy,
* lesions, wounds, infections and suffering from malignant diseases or tumor and thrombophlebitis in the area at the selected acupuncture point
* increasing liver function three times above normal values.
Minimum Eligible Age

19 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Indonesia University

OTHER

Sponsor Role lead

Responsible Party

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dr. Newanda Johni Muchtar, Sp. Ak

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Indonesia

Jakarta Pusat, DKI Jakarta, Indonesia

Site Status

Countries

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Indonesia

Other Identifiers

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medical acupuncture 2020

Identifier Type: -

Identifier Source: org_study_id

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