Acupuncture In Migraine Without Aura Patients

NCT ID: NCT04542811

Last Updated: 2020-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-01

Study Completion Date

2018-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Migraine Without Aura Acupuncture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intervention group

Intervention group will take 12 sessions of acupuncture addition to their prophylaxis treatment. Acupuncture points will be bilateral LI-4, LI-11, ST-8, ST-44, SP-6, GB-1, GB-14, GB-20, LR-3, and GV-14, GV-20. Sterile and single-use stainless steel acupuncture needles measuring 0.25x25 mm will be inserted to a depth of 10 mm and be retained for 30 minute without any further stimulation. Acupuncture will be performed by an acupuncturist with an acupuncture practitioner licence from the Turkish Ministry of Health. Adverse events will be monitored for all acupuncture sessions.

Group Type EXPERIMENTAL

Acupuncture

Intervention Type OTHER

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

Control Group

Control group will take only their migraine prophylaxis treatment. Participants will followed-up 3 months.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Acupuncture

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

15 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ataturk University

OTHER

Sponsor Role lead

Responsible Party

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Yasemin Cayir

Assoc. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yasemin Çayır

Role: STUDY_DIRECTOR

Ataturk University

Locations

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Rabia Rukiye Akinci

Erzurum, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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B.30.2.ATA.0.01.00/113

Identifier Type: -

Identifier Source: org_study_id

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