Neck PainNCT05376163
Validity of Headache Disability Index
An observational study of Neck Pain and Headache, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Neck Pain, Headache, Cervical Pain
- What is being tested?
- Survey Study
- How many people
- 250 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2022to 1 Nov 2022
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will consist of individuals with cervicogenic headache.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validity and Reliability of the Turkish Version of The Henry Ford Hospital Headache Disability Index (HDI) in Patients With Cervicogenic Headache
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.
Read the detailed description
Headache is a health problem that is reported to occur in 66% of the global population, reducing both quality of life and work productivity. The most common type is tension headache with a prevalence of 38%, followed by migraine headaches with 10%. The incidence of cervicogenic ligament pain has been shown to be between 2.5 and 4.1%. It has been reported that although the prevalence of cervicogenic headache is low compared to tension-type headache and migraine, it affects the quality of life in patients similarly.he International Headache Society has defined cervicogenic headache as pain felt in at least one area of the face or head that radiates from a source in the neck. The most common clinical picture of cervicogenic headache is neck pain, which is usually unilateral and may radiate from the occipital region to the orbit. It has been suggested that neck pain and headache are common comorbidities. Cote et al. reported that headache complaint is 10 times more common in people with neck pain than in people without neck pain.It has been reported that an average of 60-80% of individuals suffering from chronic neck pain have headache problems. C.The validity and reliability studies of the questionnaire on headache in Turkey were generally conducted in patients with migraine. Dikmen et al. performed the Turkish validity and reliability study of the Headache Impact Test-6 (Headache Impact Test-6) questionnaire in patients with migraine. Ertaş et al. published the Turkish version of the Migraine Disability (MIDAS) Questionnaire in the same patient group. However, we could not find a Turkish validity and reliability study of a questionnaire in patients with cervicogenic headache in our country.
The Henry Ford Hospital Headache Disability Questionnaire (HDI), developed by Jacobson et al. in 1994, is a 25-item questionnaire that examines the effects of headache on daily life. This questionnaire has a two-factor structure emotionally and functionally. Scoring (No: 0, Sometimes:2, Yes:4) varies between 0 and 100. The higher the score, the more headache disability.
- Conditions
- Neck Pain, Headache, Cervical Pain
- Being tested
- Survey Study
- Keywords
- Cervicogenic headache, Cervical Spine, Validity
- Medical subject headings
- Neck Pain, Headache, Post-Traumatic Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey StudyOther
Headache Disabilty Index (HDI) will be applied.
| Study group | Role | What they receive |
|---|---|---|
| Individuals with headache | Individuals with headaches caused by neck problems Receives: Other: Survey Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache Disability Index (HDI)
Headache Disability Index evaluates the effects of headache on quality of life and disability.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2022
- Study start1 Sep 2022 (estimated)
- Primary completion1 Oct 2022 (estimated)
- Study completion1 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozlem Ulger, Hacettepe University
- Investigators
- Dilara Onan, MSc, Study chair, Hacettepe UniversityÖzlem Ülger, Study director, Hacettepe Üniversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05376163
- Sponsor's protocol ID
- GO 22/670
- Status last verified
- Aug 2022
- First submitted
- 11 May 2022
- Last updated
- 4 Aug 2022
- 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 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability of the Turkish Version of The Henry Ford Hospital Headache Disability Index (HDI) in Patients With Cervicogenic Headache
- ClinicalTrials.gov ID
- NCT05376163
- Acronym / sponsor ID
- GO 22/670
- Conditions
- Neck Pain, Headache, Cervical Pain
- Keywords
- Cervicogenic headache, Cervical Spine, Validity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 1 Nov 2022 (estimated)
- First posted
- 17 May 2022 (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.
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.
Detailed description
Headache is a health problem that is reported to occur in 66% of the global population, reducing both quality of life and work productivity. The most common type is tension headache with a prevalence of 38%, followed by migraine headaches with 10%. The incidence of cervicogenic ligament pain has been shown to be between 2.5 and 4.1%. It has been reported that although the prevalence of cervicogenic headache is low compared to tension-type headache and migraine, it affects the quality of life in patients similarly.he International Headache Society has defined cervicogenic headache as pain felt in at least one area of the face or head that radiates from a source in the neck. The most common clinical picture of cervicogenic headache is neck pain, which is usually unilateral and may radiate from the occipital region to the orbit. It has been suggested that neck pain and headache are common comorbidities. Cote et al. reported that headache complaint is 10 times more common in people with neck pain than in people without neck pain.It has been reported that an average of 60-80% of individuals suffering from chronic neck pain have headache problems. C.The validity and reliability studies of the questionnaire on headache in Turkey were generally conducted in patients with migraine. Dikmen et al. performed the Turkish validity and reliability study of the Headache Impact Test-6 (Headache Impact Test-6) questionnaire in patients with migraine. Ertaş et al. published the Turkish version of the Migraine Disability (MIDAS) Questionnaire in the same patient group. However, we could not find a Turkish validity and reliability study of a questionnaire in patients with cervicogenic headache in our country.
The Henry Ford Hospital Headache Disability Questionnaire (HDI), developed by Jacobson et al. in 1994, is a 25-item questionnaire that examines the effects of headache on daily life. This questionnaire has a two-factor structure emotionally and functionally. Scoring (No: 0, Sometimes:2, Yes:4) varies between 0 and 100. The higher the score, the more headache disability.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individuals with headache | – | Other: Survey StudyIndividuals with headaches caused by neck problems |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of individuals with cervicogenic headache.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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
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 |
|---|---|---|
| Survey StudyHeadache Disabilty Index (HDI) will be applied. | Other | Individuals with headache |
Primary outcome
Headache Disability Index (HDI)
Time frame: 15 minutes
Headache Disability Index evaluates the effects of headache on quality of life and disability.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2022.
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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.
Dilara Onan, MSc study chair
Hacettepe University
Özlem Ülger study director
Hacettepe Üniversity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neck Pain and Headache, run by Hacettepe 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 2 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 4 Aug 2022. 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 Hasan Erkan Kılınç, Phd (5074825260 ext. +90, erkankilinc86@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Headache Disability Index (HDI) (time frame: 15 minutes). 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 4 Aug 2022.