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Acupuncture In Migraine Without Aura Patients

Primary Purpose

Migraine Without Aura, Acupuncture

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Acupuncture
Sponsored by
Ataturk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Migraine Without Aura focused on measuring migraine, acupuncture, MIDAS

Eligibility Criteria

15 Years - 55 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Rabia Rukiye Akinci

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control Group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Monthly attack frequency
The participants will document the each migraine attack days in a month by pain free intervals of at least 48 hours.
Duration of attacks
Duration of the each migraine attack as hour
Pain severity
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 Outcome Measures

Disability
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).

Full Information

First Posted
September 2, 2020
Last Updated
September 11, 2020
Sponsor
Ataturk University
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1. Study Identification

Unique Protocol Identification Number
NCT04542811
Brief Title
Acupuncture In Migraine Without Aura Patients
Official Title
Acupuncture For Preventing Of Attack Frequency And Improving Disability In Migraine Without Aura Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
August 31, 2018 (Actual)
Study Completion Date
September 30, 2018 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Without Aura, Acupuncture
Keywords
migraine, acupuncture, MIDAS

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Control group will take only their migraine prophylaxis treatment. Participants will followed-up 3 months.
Intervention Type
Other
Intervention Name(s)
Acupuncture
Intervention Description
Acupuncture is a complementary therapy modality which is used by needle inserted the specific points on the body.
Primary Outcome Measure Information:
Title
Monthly attack frequency
Description
The participants will document the each migraine attack days in a month by pain free intervals of at least 48 hours.
Time Frame
3 months
Title
Duration of attacks
Description
Duration of the each migraine attack as hour
Time Frame
3 months
Title
Pain severity
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Disability
Description
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).
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yasemin Çayır
Organizational Affiliation
Ataturk University
Official's Role
Study Director
Facility Information:
Facility Name
Rabia Rukiye Akinci
City
Erzurum
ZIP/Postal Code
25040
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Acupuncture In Migraine Without Aura Patients

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