Clinical trial NCT05282134: Comparison of Wet Cupping and Acupuncture in Migraine
Official title: Comparison of the Effectiveness of Wet Cupping and Acupuncture in Migraine: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine
Keywords: Migrain, Wet Cupping, Acupuncture, VAS, MIDAS
Lead sponsor: Karabuk University
Sponsor class: OTHER
First posted: 2022-03-16
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: TREATMENT

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.

Detailed description: Background: The most common primary headache is migraine. Migraine was ranked as the sixth cause of years lost due to disability all over the world in 2013. . About 15% of the world's population has migraine. Every year, 14-35% of women and 6-15% of men have migraine. The economic burden caused by the disease, which is so common and affects new masses every year, is substantial, as well as the loss of workforce, treatment costs. According to the UK-NHS data; Migraines cause an economic burden of 2.25 billion pounds based on 25 million lost days each year and more than 150 million pounds based on care, examinations, and treatment. There may be some side effects, drug interactions, comorbid conditions, and resistance cases in pharmacological treatments. In this context, traditional treatment methods may be preferred due to the low incidence of side effects. . In this context, traditional treatment methods may be preferred due to the low incidence of side effects. Acupuncture, which is widely used among traditional methods, has been shown to reduce the frequency of headaches. There are few studies on the effectiveness of Hijama, which is another traditional method and frequently used in our geography,

Purpose: The aim of the study is to investigate and compare the efficacy of wet cupping and acupuncture therapies in patients with migraine

Method: The patients who were referred to Umraniye Training Hospital Neurology polyclinic and diagnosed with migraine will be enrolled in the study.

The inclusion criteria are being 18-65 years old, having been diagnosed with migraine (ICHD-3 diagnosis criteria), and consenting to participate in the study. Those who are accompanied with any chronic disease and on daily medication, contraindicated to WCT as determined in the routine blood tests that were routinely performed before the prior to application (Hgb \<9,5; INR\> 1,2,; Hgb \<9,5, etc) and who received WCT in the last three months will be excluded.

The volunteers will be randomized into three separate groups as wet cupping, acupuncture, and control group Control group will not receive any intervention. The wet cupping group will undergo 3 successive WCT sessions once in a month throughout 3 months (On 0, 30, and 60 days). Vacuum cups will be used on different acupuncture points to perform WCT: The one on the posterior median line, in the depression below the processus spinosus of the 7th cervical vertebra, was DU 14 (Dazhui) point; the ones on the back, 3.0 cm lateral to the lower border of the spinous process of the 3rd thoracic vertebra interscapulum region were UB 42 (Pohu) bilateral points; and the ones on the back, 3.0 cm lateral to the lower border of the spinous process of the 7th thoracic vertebra were UB 46 (Geguan) bilateral points and additionally the patient's trigger points which we detect during the examination. There will be 5-7 points in total. The technique used will be triple S (Sucking, Scarification, Sucking) in all sessions.

The acupuncture group will receive acupuncture application which will be done by manually needling on 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 will be left for 20 minutes.

At 0 and 3 months, MIDAS and VAS questionnaires will be applied to all patient groups Evaluation and comparison between the groups will be made with the scores of these questionnaires.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 1. Having a bleeding diathesis

  2. Receiving antithrombotic and antiaggregant therapy

  3. Chronic disease that requires continuous drug use have

  4. 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

Primary outcomes:
measure: The change from the baseline (at 0 month) MIDAS scores at 3th month
timeFrame: At 0 and 3 months
measure: The change from the baseline (at 0 month) VAS scores at 3 th month
timeFrame: At 0 and 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Umraniye Training and Research Hospital
state: İ̇stanbul
Study officials:
affiliation: Saglik Bilimleri Universitesi
name: Emin Pala
role: STUDY_CHAIR
References: