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

Primary Purpose

Migraine, Headache, Migraine Disorders

Status
Completed
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
acupuncture
Sponsored by
Indonesia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Migraine focused on measuring migraine, acupuncture, visual analogue scale, headache

Eligibility Criteria

19 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Indonesia

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

acupuncture

standard treatment for migraine by neurologist

Arm Description

acupuncture three times a week

standard treatment for migraine that was given by a neurologist

Outcomes

Primary Outcome Measures

frequency
Manual acupuncture interventions can reduce the frequency of migraine attacks better than the preventive pharmacological valproic acid
duration
Manual acupuncture interventions can reduce the duration of migraine attacks better than the preventive pharmacological valproic acid
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
frequency
Manual acupuncture interventions can reduce the frequency of migraine attacks better than the preventive pharmacological valproic acid
duration
Manual acupuncture interventions can reduce the duration of migraine attacks better than the preventive pharmacological valproic acid
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

Secondary Outcome Measures

Full Information

First Posted
August 6, 2020
Last Updated
August 8, 2020
Sponsor
Indonesia University
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1. Study Identification

Unique Protocol Identification Number
NCT04509141
Brief Title
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

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
July 5, 2019 (Actual)
Primary Completion Date
August 7, 2019 (Actual)
Study Completion Date
August 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indonesia University

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine, Headache, Migraine Disorders
Keywords
migraine, acupuncture, visual analogue scale, headache

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
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
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
acupuncture
Arm Type
Active Comparator
Arm Description
acupuncture three times a week
Arm Title
standard treatment for migraine by neurologist
Arm Type
Active Comparator
Arm Description
standard treatment for migraine that was given by a neurologist
Intervention Type
Other
Intervention Name(s)
acupuncture
Intervention Description
acupuncture points used were EXHN5 Taiyang, GB20 Fengchi, TE5 Waigun, GB41 Zulinqi
Primary Outcome Measure Information:
Title
frequency
Description
Manual acupuncture interventions can reduce the frequency of migraine attacks better than the preventive pharmacological valproic acid
Time Frame
at week 4
Title
duration
Description
Manual acupuncture interventions can reduce the duration of migraine attacks better than the preventive pharmacological valproic acid
Time Frame
at week 4
Title
intensity
Description
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
Time Frame
at week 4
Title
frequency
Description
Manual acupuncture interventions can reduce the frequency of migraine attacks better than the preventive pharmacological valproic acid
Time Frame
at week 8
Title
duration
Description
Manual acupuncture interventions can reduce the duration of migraine attacks better than the preventive pharmacological valproic acid
Time Frame
at week 8
Title
intensity
Description
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
Time Frame
at week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
University of Indonesia
City
Jakarta Pusat
State/Province
DKI Jakarta
ZIP/Postal Code
10440
Country
Indonesia

12. IPD Sharing Statement

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

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