MigraineNCT07145372
Diaphragm Relaxation Techniques, Diaphragmatic Breathing Exercises for Migraine Patients
A study testing Manual therapy, Diaphragmatic relaxation technique and Shoulder ROM exercise in people with Migraine and Migraine Disease, run by Seda Saka at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Migraine, Migraine Disease, Manuel Therapy
- What is being tested?
- Manual therapy, Diaphragmatic relaxation technique and Shoulder ROM exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2023to 30 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Study of Diaphragm Relaxation Techniques, Diaphragmatic Breathing Exercises, and Manual Therapy on Pain and Quality of Life in Individuals With Migraine
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
- Being tested
- Manual therapy, Diaphragmatic relaxation technique, Shoulder ROM exercise
- Keywords
- Diaphragm Relaxation, Manual Therapy, Migraine
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual therapyOther
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 techniqueOther
It includes diaphragm manual release techniques and a diaphragmatic breathing exercise program
Shoulder ROM exerciseOther
This group was given a home exercise program consisting of shoulder girdle range of motion (ROM) exercises that do not affect the cervical region.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Manual therapy |
| Diaphragm relaxation group | Experimental | It includes diaphragm manual release techniques and a diaphragmatic breathing exercise program Receives: 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. Receives: Other: Shoulder ROM exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and at the end of third week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start1 Jan 2023
- Primary completion30 May 2024
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seda Saka
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Seda Saka, Halic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07145372
- Sponsor's protocol ID
- EH250
- Status last verified
- Aug 2025
- First submitted
- 13 Aug 2025
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Diaphragm Relaxation Techniques, Diaphragmatic Breathing Exercises, and Manual Therapy on Pain and Quality of Life in Individuals With Migraine
- ClinicalTrials.gov ID
- NCT07145372
- Acronym / sponsor ID
- EH250
- Conditions
- Migraine, Migraine Disease, Manuel Therapy, Diaphragm Relaxation
- Keywords
- Diaphragm Relaxation, Manual Therapy, Migraine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Seda SakaUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 28 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Manual therapy group | Experimental | Other: Manual therapyIt 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. |
| Diaphragm relaxation group | Experimental | Other: Diaphragmatic relaxation techniqueIt includes diaphragm manual release techniques and a diaphragmatic breathing exercise program |
| Control group | Sham comparator | Other: Shoulder ROM exerciseThis group was given a home exercise program consisting of shoulder girdle range of motion (ROM) exercises that do not affect the cervical region. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual therapyIt 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 group |
| Diaphragmatic relaxation techniqueIt includes diaphragm manual release techniques and a diaphragmatic breathing exercise program | Other | Diaphragm relaxation group |
| Shoulder ROM exerciseThis group was given a home exercise program consisting of shoulder girdle range of motion (ROM) exercises that do not affect the cervical region. | Other | Control group |
Primary outcome
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual therapy, Diaphragmatic relaxation technique and Shoulder ROM exercise in people with Migraine and Migraine Disease, run by Seda Saka at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) (time frame: Baseline and at the end of third week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2025.