Migraine DisordersNCT05797012
The Association Among Headache Severity, Head Posture, Cervical Muscle Endurance, and Neck Disorders in Individuals With Migraine
A study testing To assess headache severity, head posture, cervical muscle endurance and neck disorders. in people with Migraine Disorders, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
Trial summary
To determine the relationship among headache severity, head posture, cervical muscle endurance and neck disorders in individuals with migraine. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine Disorders
- What is being tested?
- To assess headache severity, head posture, cervical muscle endurance and neck disorders.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2023to 1 Dec 2023
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having been diagnosed with migraine at any time in his life and complaining of headache,
- Not having any diagnosed chronic disease,
- No past or present mental illness,
- Individuals who can speak, read and write Turkish.
Who cannot join
- Having any neurological, psychiatric or cognitive disorder,
- Individuals who cannot speak, read or write Turkish.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Tokat Gaziosmanpasa University
Merkez, Tokat Province, 60250
Halime ARIKAN, PhD, +90 546 576 51 32, halimearikan92@gmail.com
About this study
To determine the relationship among headache severity, head posture, cervical muscle endurance and neck disorders in individuals with migraine.
Read the detailed description
Headache is a general health problem that can be seen in different age groups, is common, depends on many factors, and has a lot of individual and socioeconomic effects. It is stated that the rate of individuals who experience a headache at least once in their lifetime is very high in the general population. Migraine is one of the most common types of primary headache. Neck pain and cervical dysfunctions in individuals with migraine have been the subject of many studies. It is seen that studies examining the relationship between cervical region musculoskeletal system disorders and headache in different types of headaches are increasing day by day. This study aims to determine the relationship among headache severity, head posture, cervical muscle endurance and neck disorders in individuals with migraine. In addition, the relationship between these parameters and quality of life will be examined.
- Conditions
- Migraine Disorders
- Being tested
- To assess headache severity, head posture, cervical muscle endurance and neck disorders.
- Keywords
- Headache, Head posture, Neck disorders, Migraine, Cervical endurance
- Medical subject headings
- Migraine Disorders, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
To assess headache severity, head posture, cervical muscle endurance and neck disorders.Other
To assess headache severity, head posture, cervical muscle endurance and neck disorders.
| Study group | Role | What they receive |
|---|---|---|
| Individuals with migraine | Other | To assess headache severity, head posture, cervical muscle endurance and neck disorders. Receives: Other: To assess headache severity, head posture, cervical muscle endurance and neck disorders. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache severity
Headache Impact Test-6 (HIT-6) will be used to question individuals' headache. This test, which consists of 6 items, evaluates the problems that arise due to headache in a wide framework. It provides information based on the patient's self-report. The HIT-6 score ranges from 36 to 78 points. A higher score indicates more influence. Turkish validity and reliability study of HIT-6 was conducted.
Measured: 1 day
Head posture
Head posture will be recorded in degrees (°) by measuring the horizontal plane and the angle between the seventh cervical vertebra (C7) and the ear with an electrogoniometer (BASELINE® goniometer, Digital Absolute+Axis, Fabrication Enterprises (White Plains, New York)). None of the individuals will be informed about the head position to avoid bias in the study.
Measured: 1 day
Cervical muscle endurance
The endurance of the cervical muscles will be evaluated with the deep cervical flexor endurance test and the cervical extensor endurance test.
Measured: 1 day
Neck disorders
Neck disorders will be assessed by the Bournemouth Questionnaire (BQ) in 2002. BQ consists of 7 questions in total. Each question scores between 0 and 10. Although the highest score is 70, a high score indicates a high level of disability. The content of the questionnaire consists of variables that must be questioned for individuals with neck pain, such as pain severity, the effect of pain on activities of daily living and social life, anxiety-depression level, kinesiophobia, and coping with pain. The validity and reliability of the Turkish version of the BQ has been proven.
Measured: 1 day
General quality of life
The Nottingham Health Profile (NHP) is a general quality of life questionnaire that measures a person's perceived health problems and the extent to which these problems affect normal daily activities. The questionnaire consists of 38 items. Questions are answered as 'yes' or 'no'. The questionnaire assesses six parameters related to health status. These parameters are; pain (8 items), physical activity (8 items), energy (3 items), sleep (5 items), social isolation (5 items), and emotional reactions (9 items). Each sub-parameter is scored between 0-100. 0 indicates best health, and 100 indicates worst health. The total NHP score is derived from the sum of the subscores.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2023
- Study start1 Apr 2023
- Primary completion1 Nov 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine DisordersStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tokat Gaziosmanpasa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Halime Arikan, Tokat Gaziosmanpasa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05797012
- Sponsor's protocol ID
- 83116987-711
- Status last verified
- Sep 2023
- First submitted
- 16 Mar 2023
- Last updated
- 14 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Among Headache Severity, Head Posture, Cervical Muscle Endurance, and Neck Disorders in Individuals With Migraine
- ClinicalTrials.gov ID
- NCT05797012
- Acronym / sponsor ID
- 83116987-711
- Conditions
- Migraine Disorders
- Keywords
- Headache, Head posture, Neck disorders, Migraine, Cervical endurance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Tokat Gaziosmanpasa UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Nov 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 4 Apr 2023 (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.
To determine the relationship among headache severity, head posture, cervical muscle endurance and neck disorders in individuals with migraine.
Detailed description
Headache is a general health problem that can be seen in different age groups, is common, depends on many factors, and has a lot of individual and socioeconomic effects. It is stated that the rate of individuals who experience a headache at least once in their lifetime is very high in the general population. Migraine is one of the most common types of primary headache. Neck pain and cervical dysfunctions in individuals with migraine have been the subject of many studies. It is seen that studies examining the relationship between cervical region musculoskeletal system disorders and headache in different types of headaches are increasing day by day. This study aims to determine the relationship among headache severity, head posture, cervical muscle endurance and neck disorders in individuals with migraine. In addition, the relationship between these parameters and quality of life will be examined.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individuals with migraine | Other | Other: To assess headache severity, head posture, cervical muscle endurance and neck disorders.To assess headache severity, head posture, cervical muscle endurance and neck disorders. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Having been diagnosed with migraine at any time in his life and complaining of headache,
- Not having any diagnosed chronic disease,
- No past or present mental illness,
- Individuals who can speak, read and write Turkish.
Key exclusion criteria (2 listed)
- Having any neurological, psychiatric or cognitive disorder,
- Individuals who cannot speak, read or write Turkish.
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 |
|---|---|---|
| To assess headache severity, head posture, cervical muscle endurance and neck disorders.To assess headache severity, head posture, cervical muscle endurance and neck disorders. | Other | Individuals with migraine |
Primary outcome
Headache severity
Time frame: 1 day
Headache Impact Test-6 (HIT-6) will be used to question individuals' headache. This test, which consists of 6 items, evaluates the problems that arise due to headache in a wide framework. It provides information based on the patient's self-report. The HIT-6 score ranges from 36 to 78 points. A higher score indicates more influence. Turkish validity and reliability study of HIT-6 was conducted.
Head posture
Time frame: 1 day
Head posture will be recorded in degrees (°) by measuring the horizontal plane and the angle between the seventh cervical vertebra (C7) and the ear with an electrogoniometer (BASELINE® goniometer, Digital Absolute+Axis, Fabrication Enterprises (White Plains, New York)). None of the individuals will be informed about the head position to avoid bias in the study.
Cervical muscle endurance
Time frame: 1 day
The endurance of the cervical muscles will be evaluated with the deep cervical flexor endurance test and the cervical extensor endurance test.
Neck disorders
Time frame: 1 day
Neck disorders will be assessed by the Bournemouth Questionnaire (BQ) in 2002. BQ consists of 7 questions in total. Each question scores between 0 and 10. Although the highest score is 70, a high score indicates a high level of disability. The content of the questionnaire consists of variables that must be questioned for individuals with neck pain, such as pain severity, the effect of pain on activities of daily living and social life, anxiety-depression level, kinesiophobia, and coping with pain. The validity and reliability of the Turkish version of the BQ has been proven.
General quality of life
Time frame: 1 day
The Nottingham Health Profile (NHP) is a general quality of life questionnaire that measures a person's perceived health problems and the extent to which these problems affect normal daily activities. The questionnaire consists of 38 items. Questions are answered as 'yes' or 'no'. The questionnaire assesses six parameters related to health status. These parameters are; pain (8 items), physical activity (8 items), energy (3 items), sleep (5 items), social isolation (5 items), and emotional reactions (9 items). Each sub-parameter is scored between 0-100. 0 indicates best health, and 100 indicates worst health. The total NHP score is derived from the sum of the subscores.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing To assess headache severity, head posture, cervical muscle endurance and neck disorders. in people with Migraine Disorders, run by Tokat Gaziosmanpasa University 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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 14 Sep 2023. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Halime ARIKAN, PhD (+90 546 576 51 32, halimearikan92@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Headache severity (time frame: 1 day). The study lists 5 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 14 Sep 2023.