Acupuncture In Migraine Without Aura Patients

Not Applicable

Completed

• Conditions: Acupuncture; Migraine Without Aura
• Interventions: Other: Acupuncture

• Registration Number: NCT04542811
• Lead Sponsor: Ataturk University

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.

Study Timeline

• Study Start: 2018-03-01
• Primary Completion: 2018-08-31
• Study Completion: 2018-09-30
• Status Verified: 2020-09
• Study First Submitted: 2020-09-02
• Study First Submitted QC: 2020-09-08
• Study First Posted: 2020-09-09
• Last Update Submitted: 2020-09-11
• Last Update Posted: 2020-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Acupuncture	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.

Primary Outcome Measures

Name	Time	Method
Monthly attack frequency	3 months	The participants will document the each migraine attack days in a month by pain free intervals of at least 48 hours.
Duration of attacks	3 months	Duration of the each migraine attack as hour
Pain severity	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 Outcome Measures

Name	Time	Method
Disability	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).

Trial Locations

Locations (1)

Rabia Rukiye Akinci; 🇹🇷 Erzurum, Turkey