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临床试验/NCT05282134
NCT05282134已完成不适用

Comparison of the Effectiveness of Wet Cupping and Acupuncture in Migraine: A Randomized Controlled Study

Karabuk University2 个研究点 分布在 2 个国家目标入组 150 人开始时间: 2022年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
150
试验地点
2
主要终点
The change from the baseline (at 0 month) MIDAS scores at 3th month

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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
  • Having a hemoglobin value below 9.5 g/dl
  • INR value over 1.5

研究组 & 干预措施

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.

干预措施: Wet cupping therapy (Procedure)

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.

干预措施: Acupuncture (Procedure)

Control

No Intervention

Control group will not receive any intervention

结局指标

主要结局

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

时间窗: At 0 and 3 months

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

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

时间窗: At 0 and 3 months

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."

次要结局

未报告次要终点

研究者

发起方
Karabuk University
申办方类型
Other
责任方
Principal Investigator
主要研究者

SULEYMAN ERSOY

Head of the complementary medicine department

Karabuk University

研究点 (2)

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Comparison of Wet Cupping and Acupuncture in Migraine | 临床试验