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Completed

NCT Number: NCT04542811

Acupuncture In Migraine Without Aura Patients

The investigators aimed to investigate the effect of acupuncture treatment on attack frequency, pain intensity, and disability in migraine without aura patients who receive prophylaxis treatment.

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Key information

Conditions

Migraine Without Aura Acupuncture Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

15 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rabia Rukiye Akinci

Erzurum, 25040, Turkey (Türkiye)

About this study

Acupuncture is a Traditional Chinese Medicine method that has been used for 3000 years to control symptoms, treat illnesses, and relieve pain. Acupuncture is widely used in many countries today as a complementary therapy, especially in cases of chronic pain. Migraine is one of the diseases in which acupuncture treatment is commonly used. Studies conducted so far have focused more on the effect of acupuncture on pain intensity in patients with migraine. Data comparing the impact of acupuncture on both the attack frequency and disability in migraine are relatively scarce.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Being diagnosed with migraine according to IHS (International Headache Association)
  • Receiving migraine prophylaxis treatment
  • Having more than four attacks per month/more than one attack per week
  • Not having received acupuncture treatment before.

Exclusion criteria

  • Being diagnosed with migraine with aura/secondary headache
  • Having received acupuncture treatment for any reason within the last year
  • Not giving consent for acupuncture treatment
  • Having a fear of needles.

Treatment and study plan

Acupuncture

Other

Acupuncture is a complementary therapy modality which is used by needle inserted the specific points on the body.

Primary outcomes

  1. Monthly attack frequency

    Time frame: 3 months

    The participants will document the each migraine attack days in a month by pain free intervals of at least 48 hours.

  2. Duration of attacks

    Time frame: 3 months

    Duration of the each migraine attack as hour

  3. Pain severity

    Time frame: 3 months

    Pain severity during migraine attacks will be measured via visual analog scale (VAS). While 0 indicates no pain, 10 indicates the most severe pain imaginable.

Secondary outcomes

  1. Disability

    Time frame: 3 months

    Disability will measured via a questionnaire which is an ordinary rating scale to assess the migraine related disability of a patient with migraine. Migraine Disability Assessment (MIDAS) will be used. Migraine Disability Assessment (MIDAS) questionnaire is an ordinary rating scale to assess the migraine related disability of a patient with migraine. It is based on responses to five questions about disability associated with headache in the last three months. MIDAS questionnaire has four point grading system. Scores ranging from 0 to 5 indicates Grade 1 (little or none disability), scores ranging from 6 to 10 indicates Grade 2 (mild disability), scores ranging from 11 to 20 indicates Grade 3 (moderate disability), and scores 21 or greater indicates Grade 4 (severe disability).

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Registry information

Official study title

Acupuncture For Preventing Of Attack Frequency And Improving Disability In Migraine Without Aura Patients

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Sep 9, 2020
Registry last updated
Sep 16, 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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