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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04542811
Other study ID # B.30.2.ATA.0.01.00/113
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2018
Est. completion date September 30, 2018

Study information

Verified date September 2020
Source Ataturk University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 84
Est. completion date September 30, 2018
Est. primary completion date August 31, 2018
Accepts healthy volunteers No
Gender All
Age group 15 Years to 55 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Turkey Rabia Rukiye Akinci Erzurum

Sponsors (1)

Lead Sponsor Collaborator
Ataturk University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Monthly attack frequency The participants will document the each migraine attack days in a month by pain free intervals of at least 48 hours. 3 months
Primary Duration of attacks Duration of the each migraine attack as hour 3 months
Primary 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. 3 months
Secondary 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). 3 months
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