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The Association Among Headache Severity, Head Posture, Cervical Muscle Endurance, and Neck Disorders in Individuals With Migraine

Primary Purpose

Migraine Disorders

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
To assess headache severity, head posture, cervical muscle endurance and neck disorders.
Sponsored by
Tokat Gaziosmanpasa University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Migraine Disorders focused on measuring Headache, Head posture, Neck disorders, Migraine, Cervical endurance

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Tokat Gaziosmanpasa UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Individuals with migraine

Arm Description

To assess headache severity, head posture, cervical muscle endurance and neck disorders.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
March 16, 2023
Last Updated
September 13, 2023
Sponsor
Tokat Gaziosmanpasa University
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1. Study Identification

Unique Protocol Identification Number
NCT05797012
Brief Title
The Association Among Headache Severity, Head Posture, Cervical Muscle Endurance, and Neck Disorders in Individuals With Migraine
Official Title
The Association Among Headache Severity, Head Posture, Cervical Muscle Endurance, and Neck Disorders in Individuals With Migraine
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tokat Gaziosmanpasa University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Disorders
Keywords
Headache, Head posture, Neck disorders, Migraine, Cervical endurance

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Individuals with migraine
Arm Type
Other
Arm Description
To assess headache severity, head posture, cervical muscle endurance and neck disorders.
Intervention Type
Other
Intervention Name(s)
To assess headache severity, head posture, cervical muscle endurance and neck disorders.
Intervention Description
To assess headache severity, head posture, cervical muscle endurance and neck disorders.
Primary Outcome Measure Information:
Title
Headache severity
Description
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.
Time Frame
1 day
Title
Head posture
Description
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.
Time Frame
1 day
Title
Cervical muscle endurance
Description
The endurance of the cervical muscles will be evaluated with the deep cervical flexor endurance test and the cervical extensor endurance test.
Time Frame
1 day
Title
Neck disorders
Description
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.
Time Frame
1 day
Title
General quality of life
Description
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.
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Halime ARIKAN, PhD
Phone
+90 546 576 51 32
Email
halimearikan92@gmail.com
Facility Information:
Facility Name
Tokat Gaziosmanpasa University
City
Merkez
State/Province
Tokat
ZIP/Postal Code
60250
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Halime ARIKAN, PhD
Phone
+90 546 576 51 32
Email
halimearikan92@gmail.com

12. IPD Sharing Statement

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The Association Among Headache Severity, Head Posture, Cervical Muscle Endurance, and Neck Disorders in Individuals With Migraine

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