Acupuncture In Migraine Without Aura Patients

September 11, 2020 updated by: Yasemin Cayir, Ataturk University

Acupuncture For Preventing Of Attack Frequency And Improving Disability 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Erzurum, Turkey, 25040
        • Rabia Rukiye Akinci

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 55 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: Acupuncture
Acupuncture is a complementary therapy modality which is used by needle inserted the specific points on the body.
No Intervention: Control Group
Control group will take only their migraine prophylaxis treatment. Participants will followed-up 3 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months
Duration of attacks
Time Frame: 3 months
Duration of the each migraine attack as hour
3 months
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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ataturk University

Investigators

  • Study Director: Yasemin Çayır, Ataturk University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2018

Primary Completion (Actual)

August 31, 2018

Study Completion (Actual)

September 30, 2018

Study Registration Dates

First Submitted

September 2, 2020

First Submitted That Met QC Criteria

September 8, 2020

First Posted (Actual)

September 9, 2020

Study Record Updates

Last Update Posted (Actual)

September 16, 2020

Last Update Submitted That Met QC Criteria

September 11, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B.30.2.ATA.0.01.00/113

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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