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OpenTrials
Completed

NCT Number: NCT04509141

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.

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Key information

Age range

19 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Indonesia

Jakarta Pusat, DKI Jakarta, 10440, Indonesia

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Acupuncture

Other

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

Primary outcomes

  1. frequency

    Time frame: at week 4

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

  2. duration

    Time frame: at week 4

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

  3. intensity

    Time frame: at week 4

    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

  4. frequency

    Time frame: at week 8

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

  5. duration

    Time frame: at week 8

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

  6. intensity

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Aug 11, 2020
Registry last updated
Aug 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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