NCT05797012

Brief Summary

To determine the relationship among headache severity, head posture, cervical muscle endurance and neck disorders in individuals with migraine.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 16, 2023

Completed
16 days until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 4, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

September 14, 2023

Status Verified

September 1, 2023

Enrollment Period

7 months

First QC Date

March 16, 2023

Last Update Submit

September 13, 2023

Conditions

Migraine Disorders

Keywords

HeadacheHead postureNeck disordersMigraineCervical endurance

Outcome Measures

Primary Outcomes (5)

  • 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.

    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.

    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.

    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.

    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.

    1 day

Study Arms (1)

Individuals with migraine

OTHER

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.

Interventions

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.

Individuals with migraine

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Having any neurological, psychiatric or cognitive disorder,
  • Individuals who cannot speak, read or write Turkish.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tokat Gaziosmanpasa University

Merkez, Tokat Province, 60250, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Migraine DisordersHeadache

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Halime ARIKAN, PhD

CONTACT

+90 546 576 51 32halimearikan92@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 16, 2023

First Posted

April 4, 2023

Study Start

April 1, 2023

Primary Completion

November 1, 2023

Study Completion

December 1, 2023

Last Updated

September 14, 2023

Record last verified: 2023-09

Locations

TU(1)