Cervicogenic HeadacheNCT05572489
Cervicogenic Headache, Cognitive Dysfunction
An observational study of Cervicogenic Headache, run by Konya Beyhekim Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The goal of this study was to determine the frequency of cognitive dysfunction in patients with cervicogenic headache. participants will be asked questions to determine their cognitive status at once. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cervicogenic Headache
- What is being tested?
- visual pain scale Beck depression scale Pain catastrophizing scale Short Form-36 Standard Mini mental test Montreal cognitive assessment scale
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2022to 1 Jan 2023
- How long will I take part?
- 1 Day
- 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
- Adult, Older adult
Study population: 30 patients with cervicogenic headache and 30 healthy volunteers
Who may be able to join
- Clinical Diagnosis of cervicogenic headache be over 18
Who cannot join
- those under the age of 18 Those with neurological deficits Those with rheumatic diseases such as fibromyalgia, polymyalgia rheumatica, ankylosing spondylitis, rheumatoid arthritis Surgery in the cervical region in the past 6 months Those with widespread pain, significant pain in another anatomical location (eg, gonarthrosis) Those who use drugs or substances (alcohol, drugs, etc.) that may cause cognitive impairment Those with known neurological diseases such as cerebrovascular disease, MS, Parkinson's, dementia Those with major psychiatric illness Those with communication problems Those who have started psychiatric medical treatment in the last three months Those with significant hearing or vision problems Those with a history of uncontrollable systemic disease (cardiovascular, pulmonary, hepatic, renal, hematological, endocrine..)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Konya Beyhekim Research and Training Hospital
Konya, Selçuklu, 42060
Savaş Karpuz, 05552057860, svskrpz@hotmail.com
Ramazan YIlmaz, MD
About this study
Official title: Frequency of Cognitive Dysfunction in Individuals With Cervicogenic Headache
The goal of this study was to determine the frequency of cognitive dysfunction in patients with cervicogenic headache.
participants will be asked questions to determine their cognitive status at once.
Read the detailed description
A set of survey-type questions will be asked to the participants. Pain and fatigue levels of the patients were measured by visual pain scale (VAS), mood states by Beck depression scale (BDI) and Pain catastrophizing scale (Pain catastrophizing scale), quality of life by Short Form-36 (SF-36), and cognitive status by Standard Mini. mental test (SMMT) and Montreal cognitive assessment scale (MOCA).
- Conditions
- Cervicogenic Headache
- Being tested
- visual pain scale Beck depression scale Pain catastrophizing scale Short Form-36 Standard Mini mental test Montreal cognitive assessment scale
- Medical subject headings
- Post-Traumatic Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
visual pain scale Beck depression scale Pain catastrophizing scale Short Form-36 Standard Mini mental test Montreal cognitive assessment scaleDiagnostic test
evaluation of pain, fatigue, mood, quality of life, cognitive status
| Study group | Role | What they receive |
|---|---|---|
| patients with cervicogenic headache | visual pain scale Beck depression scale Pain catastrophizing scale Short Form-36 Standard Mini mental test Montreal cognitive assessment scale Receives: Diagnostic Test: visual pain scale Beck depression scale Pain catastrophizing scale Short Form-36 Standard Mini mental test Montreal cognitive assessment scale | |
| healthy controls | visual pain scale Beck depression scale Pain catastrophizing scale Short Form-36 Standard Mini mental test Montreal cognitive assessment scale Receives: Diagnostic Test: visual pain scale Beck depression scale Pain catastrophizing scale Short Form-36 Standard Mini mental test Montreal cognitive assessment scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
cognitive status
Measured: 01.12.2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2022
- Study start1 Jan 2022
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cervicogenic HeadacheStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Konya Beyhekim Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Savaş Karpuz, Konya Beyhekim Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05572489
- Sponsor's protocol ID
- 2021-01-02
- Status last verified
- Oct 2022
- First submitted
- 5 Oct 2022
- Last updated
- 26 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Shared on request.
Publications
Bogduk N, Govind J. Cervicogenic headache: an assessment of the evidence on clinical diagnosis, invasive tests, and treatment. Lancet Neurol. 2009 Oct;8(10):959-68. doi: 10.1016/S1474-4422(09)70209-1.
PubMed 19747657Sjaastad O. Cervicogenic headache: comparison with migraine without aura; Vaga study. Cephalalgia. 2008 Jul;28 Suppl 1:18-20. doi: 10.1111/j.1468-2982.2008.01610.x.
PubMed 18494988
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequency of Cognitive Dysfunction in Individuals With Cervicogenic Headache
- ClinicalTrials.gov ID
- NCT05572489
- Acronym / sponsor ID
- 2021-01-02
- Conditions
- Cervicogenic Headache
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Konya Beyhekim Training and Research HospitalOther government
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 7 Oct 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 goal of this study was to determine the frequency of cognitive dysfunction in patients with cervicogenic headache.
participants will be asked questions to determine their cognitive status at once.
Detailed description
A set of survey-type questions will be asked to the participants. Pain and fatigue levels of the patients were measured by visual pain scale (VAS), mood states by Beck depression scale (BDI) and Pain catastrophizing scale (Pain catastrophizing scale), quality of life by Short Form-36 (SF-36), and cognitive status by Standard Mini. mental test (SMMT) and Montreal cognitive assessment scale (MOCA).
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with cervicogenic headache | – | Diagnostic Test: visual pain scale Beck depression scale Pain catastrophizing scale Short Form-36 Standard Mini mental test Montreal cognitive assessment scalevisual pain scale Beck depression scale Pain catastrophizing scale Short Form-36 Standard Mini mental test Montreal cognitive assessment scale |
| healthy controls | – | Diagnostic Test: visual pain scale Beck depression scale Pain catastrophizing scale Short Form-36 Standard Mini mental test Montreal cognitive assessment scalevisual pain scale Beck depression scale Pain catastrophizing scale Short Form-36 Standard Mini mental test Montreal cognitive assessment scale |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 30 patients with cervicogenic headache and 30 healthy volunteers
Key inclusion criteria (1 listed)
- Clinical Diagnosis of cervicogenic headache be over 18
Key exclusion criteria (1 listed)
- those under the age of 18 Those with neurological deficits Those with rheumatic diseases such as fibromyalgia, polymyalgia rheumatica, ankylosing spondylitis, rheumatoid arthritis Surgery in the cervical region in the past 6 months Those with widespread pain, significant pain in another anatomical location (eg, gonarthrosis) Those who use drugs or substances (alcohol, drugs, etc.) that may cause cognitive impairment Those with known neurological diseases such as cerebrovascular disease, MS, Parkinson's, dementia Those with major psychiatric illness Those with communication problems Those who have started psychiatric medical treatment in the last three months Those with significant hearing or vision problems Those with a history of uncontrollable systemic disease (cardiovascular, pulmonary, hepatic, renal, hematological, endocrine..)
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 |
|---|---|---|
| visual pain scale Beck depression scale Pain catastrophizing scale Short Form-36 Standard Mini mental test Montreal cognitive assessment scaleevaluation of pain, fatigue, mood, quality of life, cognitive status | Diagnostic test | healthy controls, patients with cervicogenic headache |
Primary outcome
cognitive status
Time frame: 01.12.2022
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2022.
- Background: PubMed 19747657Bogduk N, Govind J. Cervicogenic headache: an assessment of the evidence on clinical diagnosis, invasive tests, and treatment. Lancet Neurol. 2009 Oct;8(10):959-68. doi: 10.1016/S1474-4422(09)70209-1.
- Background: PubMed 18494988Sjaastad O. Cervicogenic headache: comparison with migraine without aura; Vaga study. Cephalalgia. 2008 Jul;28 Suppl 1:18-20. doi: 10.1111/j.1468-2982.2008.01610.x.
- Individual participant dataSharing planned: Undecided. Shared on request.
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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.
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 Cervicogenic Headache, run by Konya Beyhekim Training and Research Hospital 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 1 inclusion and 1 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 26 Oct 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cognitive status (time frame: 01.12.2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05572489, which also lists 2 linked publications.
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 26 Oct 2022.