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

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.

Study Overview

• Status: Completed
• Conditions: Migraine; Migraine Disorders; Headache
• Intervention / Treatment: Other: acupuncture

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 Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • DKI Jakarta
    • Jakarta Pusat, DKI Jakarta, Indonesia, 10440
      • University of Indonesia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 48 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: acupuncture; acupuncture three times a week	Other: acupuncture; acupuncture points used were EXHN5 Taiyang, GB20 Fengchi, TE5 Waigun, GB41 Zulinqi
Active Comparator: standard treatment for migraine by neurologist; standard treatment for migraine that was given by a neurologist	Other: acupuncture; acupuncture points used were EXHN5 Taiyang, GB20 Fengchi, TE5 Waigun, GB41 Zulinqi

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
frequency	Manual acupuncture interventions can reduce the frequency of migraine attacks better than the preventive pharmacological valproic acid	at week 4
duration	Manual acupuncture interventions can reduce the duration of migraine attacks better than the preventive pharmacological valproic acid	at week 4
intensity	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	at week 4
frequency	Manual acupuncture interventions can reduce the frequency of migraine attacks better than the preventive pharmacological valproic acid	at week 8
duration	Manual acupuncture interventions can reduce the duration of migraine attacks better than the preventive pharmacological valproic acid	at week 8
intensity	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	at week 8

Collaborators and Investigators

• Sponsor: Indonesia University

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2019
• Primary Completion (Actual): August 7, 2019
• Study Completion (Actual): August 30, 2019

Study Registration Dates

• First Submitted: August 6, 2020
• First Submitted That Met QC Criteria: August 8, 2020
• First Posted (Actual): August 11, 2020

Study Record Updates

• Last Update Posted (Actual): August 11, 2020
• Last Update Submitted That Met QC Criteria: August 8, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: acupuncture; headache; migraine; visual analogue scale
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Headache
• Other Study ID Numbers: medical acupuncture 2020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No