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临床试验/NCT07145372
NCT07145372已完成不适用

A Comparative Study of Diaphragm Relaxation Techniques, Diaphragmatic Breathing Exercises, and Manual Therapy on Pain and Quality of Life in Individuals With Migraine

Seda Saka1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2023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
42
试验地点
1
主要终点
Visual Analog Scale (VAS)

研究概览

简要总结

Migraine is a neurological disease characterized by recurring headaches. It is a significant public health problem of the top reasons for disability throughout the world. This study is planned to compare the effects of relaxation techniques of the diaphragm (midsection), diaphragmatic respiration exercises, and manual therapy applications on the severity and intensity of pain and lquality of life. 42 patients diagnosed with migraine aged between 18 and 60 participated in the study. Patients were divided into 3 groups; diaphragm relaxation group (DG), manual therapy group (MG) and control group (CG). 2 types of evaluation were carried out, one of which was pre-treatment and the other was post-treatment. Visual Analogue Scale (VAS), Megill-Melzack Pain Questionnaire, Headache Impact Test (HITS), and SF-36 Life Quality Scale were used. How long the attacks of patients before and after the treatment lasted and monthly attack numbers were recorded.

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 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Willingness to participate voluntarily and having signed informed consent
  • •Aged between 18 and 60 years
  • •Diagnosed with migraine
  • •Not receiving migraine prophylactic treatment
  • •At least primary school graduate

排除标准

  • •Using antidepressant medication
  • •Experiencing other types of headaches alongside migraine
  • •Undergoing prophylactic treatment for migraine
  • •Showing signs of vertebral artery or internal carotid artery involvement
  • •Having vertigo
  • •Having decompensated blood pressure
  • •Participated in a neck physiotherapy program within the last 3 months
  • •Lacking the mental capacity to complete the HIT-6 scale and illiterate
  • •Pregnant individuals or those who became pregnant during the study period

研究组 & 干预措施

Manual therapy group

Experimental

It includes 10 minutes of massage and myofascial release for the trapezius and neck extensors, 10 repetitions of occiput-atlas (C0-C1) joint mobilization, occiput-atlas joint manipulation, mobilization of each segment from C2 to C7 with 10 repetitions each, C2-C7 manipulation, cervicothoracic junction (C7-T1) manipulation, thoracic region (T2-T6) manipulation, and sacroiliac joint manipulation.

干预措施: Manual therapy (Other)

Diaphragm relaxation group

Experimental

It includes diaphragm manual release techniques and a diaphragmatic breathing exercise program

干预措施: Diaphragmatic relaxation technique (Other)

Control group

Sham Comparator

This group was given a home exercise program consisting of shoulder girdle range of motion (ROM) exercises that do not affect the cervical region.

干预措施: Shoulder ROM exercise (Other)

结局指标

主要结局

Visual Analog Scale (VAS)

时间窗: Baseline and at the end of third week

A Visual Analog Scale is a simple tool used to measure a person's level of pain or discomfort. It typically consists of a straight line, usually 10 cm long, where one end represents "no pain" and the other end represents "worst imaginable pain." The patient marks a point on the line that reflects their pain intensity.

McGill Pain Questionnaire (MPQ)

时间窗: Baseline and at the end of third week

It includes descriptive words categorized into sensory, affective, and evaluative dimensions, allowing patients to provide a comprehensive report of their pain experience. In our study, the score ranges from 0 to 78, with higher scores reflecting greater pain intensity and unpleasantness, meaning worse outcomes.

Headache Impact Test (HIT-6)

时间窗: Baseline and at the end of third week

The HIT-6 is a brief questionnaire designed to measure the impact of headaches on a person's daily life. It assesses pain severity, social functioning, role functioning, vitality, cognitive functioning, and psychological distress. The scores range from 36 to 78. A higher score indicates a more severe impact of headaches, so higher values reflect worse outcomes.

SF-36

时间窗: Baseline and at the end of third week

It measures overall health-related quality of life. It covers eight domains including physical functioning, bodily pain, general health, vitality, social functioning, emotional role, and mental health. Each domain is scored from 0 to 100, where higher scores represent better health status or quality of life, meaning better outcomes.

次要结局

未报告次要终点

研究者

发起方
Seda Saka
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Seda Saka

Physiotherapist, PhD

Halic University

研究点 (1)

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