NCT05376163

Brief Summary

The aim of our study is to investigate the Turkish validity and reliability of The Henry Ford Hospital Headache Disability Questionnaire (HDI), which has not been previously studied in a Turkish version for any headache type in patients with cervicogenic headache.

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
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2022

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 17, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

August 4, 2022

Status Verified

August 1, 2022

Enrollment Period

1 month

First QC Date

May 11, 2022

Last Update Submit

August 3, 2022

Conditions

Keywords

Cervicogenic headacheCervical SpineValidity

Outcome Measures

Primary Outcomes (1)

  • Headache Disability Index (HDI)

    Headache Disability Index evaluates the effects of headache on quality of life and disability.

    15 minutes

Study Arms (1)

Individuals with headache

Individuals with headaches caused by neck problems

Other: Survey Study

Interventions

Headache Disabilty Index (HDI) will be applied.

Individuals with headache

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study population will consist of individuals with cervicogenic headache.

You may qualify if:

  • Getting over 4 points from the Neck Disability Index
  • According to the 3rd edition of the International Headache Disorders Classification System (International Headache Disorders Classification 3rd edition),having at least two of the following parameters, Development of headache temporally related to the onset of cervical problems Significant reduction of headache in parallel with the improvement of cervical problems Variation in headache severity with cervical region movements Decreased range of motion in the cervical region in addition to headache

You may not qualify if:

  • Being diagnosed by a neurologist from any of the diagnoses of migraine, cluster headache syndrome, tension headache, chronic post-traumatic headache, drug-induced headache (ICD Diagnostic Codes).
  • Having a history of any neurological or systemic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hasan Erkan Kilinç

Ankara, 06510, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neck PainHeadachePost-Traumatic Headache

Interventions

Longitudinal Studies

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsHeadache Disorders, SecondaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Cohort StudiesEpidemiologic StudiesEpidemiologic Study CharacteristicsEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Dilara Onan, MSc

    Hacettepe University

    STUDY CHAIR
  • Özlem Ülger

    Hacettepe Üniversity

    STUDY DIRECTOR

Central Study Contacts

Hasan Erkan Kılınç, Phd

CONTACT

Yasemin Özel Aslıyüce, MSc

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.Dr.

Study Record Dates

First Submitted

May 11, 2022

First Posted

May 17, 2022

Study Start

September 1, 2022

Primary Completion

October 1, 2022

Study Completion

November 1, 2022

Last Updated

August 4, 2022

Record last verified: 2022-08

Locations