Diaphragm Relaxation Techniques, Diaphragmatic Breathing Exercises for Migraine Patients

NCT07145372 | Completed DMC

• 1 other identifier: EH250
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Migraine; Migraine Disease; Manuel Therapy; Diaphragm Relaxation

Keywords

Diaphragm Relaxation; Manual Therapy; Migraine

Outcome Measures

Primary Outcomes (4)

• Visual Analog Scale (VAS)

  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.

  Baseline and at the end of third week

• McGill Pain Questionnaire (MPQ)

  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.

  Baseline and at the end of third week

• Headache Impact Test (HIT-6)

  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.

  Baseline and at the end of third week

• SF-36

  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.

  Baseline and at the end of third week

Study Arms (3)

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.

Other: Manual therapy

Diaphragm relaxation group

EXPERIMENTAL

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

Other: Diaphragmatic relaxation technique

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.

Other: Shoulder ROM exercise

Interventions

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.

Manual therapy group

Diaphragmatic relaxation technique OTHER

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

Diaphragm relaxation group

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.

Control group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seda Saka: lead

Study Sites (1)

Halic University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Migraine Disorders

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Physiotherapist, PhD

Study Record Dates

• First Submitted: August 13, 2025
• First Posted: August 28, 2025
• Study Start: January 1, 2023
• Primary Completion: May 30, 2024
• Study Completion: May 30, 2024
• Last Updated: August 28, 2025

Record last verified: 2025-08

Locations

TU (1)