Acupuncture In Migraine Without Aura Patients

NCT04542811 | Completed

• 1 other identifier: B.30.2.ATA.0.01.00/113
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine Without Aura; Acupuncture

Keywords

migraine; acupuncture; MIDAS

Outcome Measures

Primary Outcomes (3)

• 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

• Duration of attacks

  Duration of the each migraine attack as hour

  3 months

• 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 Outcomes (1)

• Disability

  3 months

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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

Interventions

Acupuncture OTHER

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

Intervention group

Eligibility Criteria

• Age: 15 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Rabia Rukiye Akinci

Erzurum, 25040, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Migraine without Aura; Migraine Disorders

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Yasemin Çayır

  Ataturk University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Study Record Dates

• First Submitted: September 2, 2020
• First Posted: September 9, 2020
• Study Start: March 1, 2018
• Primary Completion: August 31, 2018
• Study Completion: September 30, 2018
• Last Updated: September 16, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)