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

Not Applicable

Completed

• Conditions: Migraine; Migraine Disorders; Headache
• Interventions: Other: acupuncture

• Registration Number: NCT04509141
• Lead Sponsor: Indonesia University

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

Study Timeline

• Study Start: 2019-07-05
• Primary Completion: 2019-08-07
• Study Completion: 2019-08-30
• Status Verified: 2020-08
• Study First Submitted: 2020-08-06
• Study First Submitted QC: 2020-08-08
• Last Update Submitted: 2020-08-08
• Study First Posted: 2020-08-11
• Last Update Posted: 2020-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
acupuncture	acupuncture	acupuncture three times a week
standard treatment for migraine by neurologist	acupuncture	standard treatment for migraine that was given by a neurologist

Primary Outcome Measures

Name	Time	Method
duration	at week 8	Manual acupuncture interventions can reduce the duration of migraine attacks better than the preventive pharmacological valproic acid
intensity	at week 8	Manual acupuncture interventions can reduce the change from Baseline in pain scores on the Visual Analog Scale of migraine attacks better than the preventive pharmacological valproic acid
frequency	at week 8	Manual acupuncture interventions can reduce the frequency of migraine attacks better than the preventive pharmacological valproic acid

Trial Locations

Locations (1)

University of Indonesia; 🇮🇩 Jakarta Pusat, DKI Jakarta, Indonesia