Comparison of Wet Cupping and Acupuncture in Migraine

NCT05282134 | Completed

• 1 other identifier: WCTACCU1
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the effects of wet cupping therapy (WCT) on migraine patients and compare it with acupuncture. The patients will be randomized into three groups. WCT will be applied once a month to patients in group 1 and acupuncture will be applied to group 2, while the control group (group 3) will be on standard therapy for migraine. An evaluation will be made before treatment and at the 3rd month using the MIDAS and VAS.

Conditions

Migraine

Keywords

Migrain, Wet Cupping, Acupuncture, VAS, MIDAS

Outcome Measures

Primary Outcomes (2)

• The change from the baseline (at 0 month) MIDAS scores at 3th month

  The Migraine Disability Assessment (MIDAS) questionnaire is a brief, self-administered questionnaire designed to quantify headache-related disability over a 3 month period.

  At 0 and 3 months

• The change from the baseline (at 0 month) VAS scores at 3 th month

  Visual analogue scales (VAS) are well-validated instruments for assessing pain intensity. Scores are recorded by a mark on a 10-cm line that represents 0 as "no pain" and 10 as "worst pain."

  At 0 and 3 months

Study Arms (3)

Wet cupping therapy

EXPERIMENTAL

The intervention group will undergo 3 successive wet cupping therapy (WCT) sessions once in a month throughout 3 months (On 0, 30, and 60 days. Cups will be held for 5 minutes on the 5 regions of the C7 cervical spine (DU14 acupuncture point), bilateral T2-4 lateral spine (BL41-42 acupoint) and bilateral T6-8 lateral spine (BL44-46) points, which are recommended areas for headache, Then, these areas where the blood supply has increased will be drawn with a sterile lancet and the cup will be applied again and left for 10 minutes, and then the cups will be removed and the accumulated blood will be cleaned.

Procedure: Wet cupping therapy

Acupuncture

EXPERIMENTAL

Acupuncture application will be done by manually needling selected acupuncture points specific to the disease twice a week for 4 weeks. After the needles are placed, they will be manipulated to create a feeling of de-qi and left for 20 minutes.

Procedure: Acupuncture

Control

NO INTERVENTION

Control group will not receive any intervention

Interventions

Wet cupping therapy PROCEDURE

Wet cupping therapy is a bloodletting application done by cups on the skin

Also known as: Hijama

Wet cupping therapy

Acupuncture PROCEDURE

Acupuncture is a complementary application of TCM done by needles

Acupuncture

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients between the ages of 18-65 who were diagnosed with migraine, no concomitant chronic disease and who gave their consent to participate in the study will be recruited.

You may not qualify if:

• \. Having a bleeding diathesis
• \. Receiving antithrombotic and antiaggregant therapy
• \. Chronic disease that requires continuous drug use have
• \. Wet cupping or hirudotherapy treatment in the last 3 months to have received 5.Be younger than 18 years old and over 65 years old 6. Having a hemoglobin value below 9.5 g/dl 7. INR value over 1.5

Sponsors & Collaborators

• Karabuk University: lead

Study Sites (1)

Umraniye Training and Research Hospital

Istanbul, İ̇stanbul, 34070, Turkey (Türkiye)

Location

MeSH Terms

Conditions

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

• Emin Pala

  Saglik Bilimleri Universitesi

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the complementary medicine department

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: March 5, 2022
• First Posted: March 16, 2022
• Study Start: January 1, 2022
• Primary Completion: August 5, 2023
• Study Completion: December 30, 2023
• Last Updated: March 26, 2024

Record last verified: 2024-03

Locations

TU (1)