Clinical trial NCT04509141: Acupuncture as Migraine Prophylaxis in Reducing Frequency, Duration and Intensity of Migraine With Minimum Acupoint, Seen up to Eight Weeks From Baseline
Official title: Acupuncture as Migraine Prophylaxis in Reducing Frequency, Duration and Intensity of Migraine With Minimum Acupoint, Seen up to Eight Weeks From Baseline
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine
Headache
Migraine Disorders
Keywords: migraine
acupuncture
visual analogue scale
headache
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2020-08-11
Enrollment: 34
Sex: ALL
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: PREVENTION

Brief summary: 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: 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

Eligibility criteria: 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.

Primary outcomes:
measure: frequency
timeFrame: at week 4
measure: duration
timeFrame: at week 4
measure: intensity
timeFrame: at week 4
measure: frequency
timeFrame: at week 8
measure: duration
timeFrame: at week 8
measure: intensity
timeFrame: at week 8
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: University of Indonesia
state: DKI Jakarta
Study officials:
References: