- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05797012
The Association Among Headache Severity, Head Posture, Cervical Muscle Endurance, and Neck Disorders in Individuals With Migraine
September 13, 2023 updated by: Halime ARIKAN, Tokat Gaziosmanpasa University
To determine the relationship among headache severity, head posture, cervical muscle endurance and neck disorders in individuals with migraine.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
34
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Halime ARIKAN, PhD
- Phone Number: +90 546 576 51 32
- Email: halimearikan92@gmail.com
Study Locations
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-
Tokat
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Merkez, Tokat, Turkey, 60250
- Recruiting
- Tokat Gaziosmanpasa University
-
Contact:
- Halime ARIKAN, PhD
- Phone Number: +90 546 576 51 32
- Email: halimearikan92@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Having any neurological, psychiatric or cognitive disorder,
- Individuals who cannot speak, read or write Turkish.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Individuals with migraine
To assess headache severity, head posture, cervical muscle endurance and neck disorders.
|
To assess headache severity, head posture, cervical muscle endurance and neck disorders.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
1 day
|
|
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.
|
1 day
|
|
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.
|
1 day
|
|
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.
|
1 day
|
|
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.
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2023
Primary Completion (Estimated)
November 1, 2023
Study Completion (Estimated)
December 1, 2023
Study Registration Dates
First Submitted
March 16, 2023
First Submitted That Met QC Criteria
March 31, 2023
First Posted (Actual)
April 4, 2023
Study Record Updates
Last Update Posted (Actual)
September 14, 2023
Last Update Submitted That Met QC Criteria
September 13, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 83116987-711
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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