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Completed

NCT Number: NCT07145372

Diaphragm Relaxation Techniques, Diaphragmatic Breathing Exercises for Migraine Patients

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.

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Diaphragm Relaxation Headache Disorders Headache Disorders, Primary Manuel Therapy Migraine Disease Migraine Disorders Nervous System Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Halic University

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Manual therapy

Other

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.

Diaphragmatic relaxation technique

Other

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

Shoulder ROM exercise

Other

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

Primary outcomes

  1. Visual Analog Scale (VAS)

    Time frame: 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.

  2. McGill Pain Questionnaire (MPQ)

    Time frame: 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.

  3. Headache Impact Test (HIT-6)

    Time frame: 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.

  4. SF-36

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Seda Saka

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 28, 2025
Registry last updated
Aug 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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