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临床试验/NCT06231615
NCT06231615已完成不适用

Efficacy of Fascia Exercises in Migraine Patients: A Randomized Controlled Trial

Ankara Yildirim Beyazıt University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年10月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
2
主要终点
Heart rate variability

研究概览

简要总结

Migraine, which is characterized by attacks and many accompanying symptoms, negatively affects the quality of life of patients. Although different methods have been tried for migraine, there is no definitive treatment approach yet. The aim of this study is to examine the effect of fascia exercises as a new approach on the symptoms and complaints of migraine patients.

The study was completed with 30 volunteer migraine patients. Participants were divided into two groups in a randomized controlled manner. While head-neck and breathing exercises were applied to the control group, fascial pattern exercises were performed in the study group in addition to these exercises. This protocol was applied 2 days a week for 6 weeks. Pain intensity, quality of life and sleep, heart rate changes, depression and anxiety levels and satisfaction levels were evaluated before and after the treatment.

Fascial pattern exercises are an effective approach on the symptoms and complaints of migraine patients and can be adopted as a complementary application in migraine treatment. Since this is the first study in this field, it needs to be supported by other studies in order to increase the provability of the effectiveness of the exercises.

详细描述

Migraine, which is characterized by attacks and many accompanying symptoms, negatively affects the quality of life of patients. Although different methods have been tried for migraine, there is no definitive treatment approach yet. The aim of this study is to examine the effect of fascia exercises as a new approach on the symptoms and complaints of migraine patients.

The study was completed with 30 volunteer migraine patients. Participants were divided into two groups in a randomized controlled manner. While head-neck and breathing exercises were applied to the control group, fascial pattern exercises were performed in the study group in addition to these exercises. This protocol was applied 2 days a week for 6 weeks. Pain intensity, quality of life and sleep, heart rate changes, depression and anxiety levels and satisfaction levels were evaluated before and after the treatment.

Demographic and descriptive characteristics of the participants were similar (p>0.05). In both groups, the number of attacks, duration of attacks, pain intensity, migraine-related disability and anxiety levels decreased and sleep quality improved after treatment (p<0.05). There was no significant difference in heart rate change parameters within and between the groups (p>0.05). There was no significant difference between the groups in terms of treatment efficacy (p>0.05). Patient satisfaction was higher in the fascia exercises group (p<0.05).

Fascial pattern exercises are an effective approach on the symptoms and complaints of migraine patients and can be adopted as a complementary application in migraine treatment. Since this is the first study in this field, it needs to be supported by other studies in order to increase the provability of the effectiveness of the exercises.

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
Single (Outcomes Assessor)

盲法说明

The evaluation of the patients was carried out by a blinded investigator, and the treatment was carried out by a different investigator.

入排标准

年龄范围
18 Years 至 59 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • having a diagnosis of migraine for at least one year
  • between the ages of 18-65 years,
  • having migraine attacks at least 5 days a month,
  • having a history of migraine starting under the age of 50,
  • giving informed written consent to participate in the study

排除标准

  • headache due to organic or secondary causes (history of subarachnoid or cerebral hemorrhage, hypertension, cerebral embolism or thrombosis),
  • receiving acupuncture treatment in the last 6 months,
  • history of bleeding diathesis or receiving anticoagulant treatment,
  • being pregnant or lactating,
  • history of malignancy,
  • having a diagnosis of depression or receiving antidepressant treatment,
  • caffeine consumption in the last 4 hours,
  • tobacco use in the last 48 hours,
  • drug and alcohol use in the last week,
  • eating within 2 hours prior to the test,
  • being unable to move independently,
  • having an uncontrolled medical condition,
  • chronic cardiovascular disease,
  • recent surgery,
  • symptoms of somatic dysfunction,
  • musculoskeletal injuries,
  • any medication that interferes with the autonomic nervous system or immune system (e.g., beta blockers, steroids, or TNF-a inhibitors)
  • any medical condition that affects the autonomic nervous system or immune system

结局指标

主要结局

Heart rate variability

时间窗: Change from baseline at 6 weeks treatment program

Heart rate variability is a tool that allows the investigation of cardiovascular autonomic function through the measurement of variations in RR intervals and provides valuable information about the control of the autonomic nervous system

次要结局

  • Level of disability due to migraine(Change from baseline at 6 weeks treatment program)
  • Pain level(Change from baseline at 6 weeks treatment program)

研究者

发起方
Ankara Yildirim Beyazıt University
申办方类型
Other
责任方
Sponsor

研究点 (2)

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