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Cervicogenic HeadacheNCT07292181

Central Sensitization and Neuropathic Pain in Cervicogenic Headache

An observational study of Cervicogenic Headache and Central Sensitization, run by Gulseren Demir Karakilic at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Cervicogenic headache is a type of secondary headache that originates from the structures of the neck and can spread toward the head and facial regions. It is often one-sided and may be triggered by neck movement or sustained posture. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
What is being tested?
Clinical assessment with standardized questionnaires
How many people
72 participants
Where
1 siteTurkey (Türkiye)
Study dates
3 Jul 2025to 3 Oct 2025
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 included 106 adult patients with cervicogenic headache and 106 age- and sex-matched healthy controls. Patients were recruited from outpatient clinics of Physical Medicine and Rehabilitation and Neurology at Bozok University, Turkey. Healthy volunteers were selected from the community and hospital staff who met the eligibility criteria.

Who may be able to join

  • Adults aged 18 to 65 years
  • Patient group: Clinical diagnosis of cervicogenic headache according to the International Classification of Headache Disorders, 3rd edition (ICHD-3) criteria
  • Healthy control group: Age- and sex-matched individuals without cervicogenic headache or other chronic pain conditions
  • Adequate cognitive function and literacy to complete questionnaires
  • Voluntary participation with written informed consent

Who cannot join

  • Age younger than 18 years or older than 65 years
  • Inability to communicate effectively
  • Illiteracy
  • Refusal to participate
  • Presence of systemic diseases including diabetes mellitus, hypothyroidism, chronic kidney disease, or malignancy
  • Neurological diseases associated with neuropathic pain
  • Rheumatologic diseases including rheumatoid arthritis, ankylosing spondylitis, or fibromyalgia
  • Withdrawal of consent or incomplete data during the study

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Yozgat Bozok University Faculty of Medicine, Department of Physical Medicine and Rehabilitation

    Yozgat, Yozgat, 66100

Other trials in Turkey (Türkiye)

About this study

Official title: Prevalence of Central Sensitization and Neuropathic Pain in Patients With Cervicogenic Headache: A Case-Control Study

Cervicogenic headache is a type of secondary headache that originates from the structures of the neck and can spread toward the head and facial regions. It is often one-sided and may be triggered by neck movement or sustained posture. The underlying mechanisms are thought to include abnormal processing of pain signals in the cervical spine and brainstem.

This case-control study was designed to examine whether individuals with cervicogenic headache show higher levels of central nervous system hypersensitivity and nerve-related pain compared with healthy individuals. The study also aimed to identify how these pain mechanisms are related to sleep, mood, and functional capacity.

Read more

The research was conducted at the Departments of Physical Medicine and Rehabilitation and Neurology of Yozgat Bozok University. Adults between 18 and 65 years of age who met the diagnostic criteria for cervicogenic headache were included. Age- and sex-matched healthy volunteers without chronic pain or neurological disorders were recruited as the control group.

Participants completed face-to-face interviews that included sociodemographic questions and a series of validated assessment tools measuring pain characteristics, psychological state, sleep quality, and quality of life. Ethical approval was obtained from the institutional review board, and all participants provided written informed consent prior to participation.

Read the detailed description

Cervicogenic headache is a secondary headache that arises from disorders or dysfunctions of the cervical spine and its associated structures. Pain usually starts in the neck region and radiates toward the occipital and temporal areas. The condition can be provoked by neck movements and may be accompanied by neck stiffness or discomfort. The pathophysiology involves the convergence of sensory inputs from the cervical nerves and the trigeminal system at the brainstem level, which may lead to the referral of pain from the neck to the head.

In recent years, researchers have proposed that abnormal central nervous system activity and neuropathic pain components may contribute to the chronicity and treatment resistance of cervicogenic headache. Central hypersensitivity refers to increased excitability of pain-related neurons, while neuropathic pain is characterized by nerve dysfunction resulting in unusual pain sensations. A limited number of studies have addressed these mechanisms together in cervicogenic headache.

The present case-control study was conducted at Yozgat Bozok University to evaluate central nervous system hypersensitivity and neuropathic pain features in patients with cervicogenic headache compared to healthy controls. Data collection took place between July 2025 and October 2025. Individuals aged 18 to 65 years who fulfilled the diagnostic criteria for cervicogenic headache were included in the patient group. Exclusion criteria included neurological disorders, systemic diseases, cognitive impairment, or other rheumatic or chronic pain conditions. Healthy volunteers of similar age and sex without headache or chronic pain were selected as the control group.

Data were obtained using a structured questionnaire covering demographic and clinical information and a series of standardized scales. Pain-related disability was measured with the Headache Impact Test and the Neck Disability Index. Emotional status was evaluated with the Hospital Anxiety and Depression Scale. Sleep quality was assessed with the Jenkins Sleep Scale. Health-related quality of life was examined with the Short Form 36 questionnaire. The presence of nerve-related pain was assessed with the Pain Detect Questionnaire, and central nervous system hypersensitivity was evaluated with the Central Sensitization Inventory.

All assessments were administered face to face in the outpatient clinics by trained clinicians. Statistical analyses were performed using appropriate parametric and non-parametric tests after checking normality of data distribution. The study was approved by the Institutional Clinical Research Ethics Committee, and all participants signed written informed consent forms prior to enrollment.

Being tested
Clinical assessment with standardized questionnaires
Keywords
Headache Disorders, Neck Pain, Pain Mechanisms, Psychological Distress, Sleep Quality, Quality of Life, Pain Assessment, Case-Control Study
Medical subject headings
Post-Traumatic Headache, Neuralgia, Headache Disorders, Neck Pain, Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Clinical assessment with standardized questionnairesOther

    Participants in both the patient group and the healthy control group underwent a structured clinical assessment using validated instruments. The evaluation included measures of central sensitization, neuropathic pain features, headache-related disability, cervical functional impairment, psychological distress, sleep quality, and health-related quality of life. The instruments administered were the Central Sensitization Inventory, PainDETECT Questionnaire, Headache Impact Test, Neck Disability Index, Hospital Anxiety and Depression Scale, Jenkins Sleep Scale, and Short Form-36. No pharmacological or procedural intervention was applied as part of the study; the primary focus was on comparative assessment between groups.

Study groups in NCT07292181
Study groupRoleWhat they receive
Patient groupAge range: 18 to 65 years Diagnosis of cervicogenic headache established according to the International Classification of Headache Disorders, 3rd edition criteria Recruited from outpatient clinics of Physical Medicine and Rehabilitation and Neurology Exclusion criteria: younger than 18 or older than 65, inability to communicate, illiteracy, refusal to participate, diabetes mellitus, hypothyroidism, chronic kidney disease, malignancy, neurological diseases associated with neuropathic pain, and rheumatic diseases such as rheumatoid arthritis, ankylosing spondylitis, or fibromyalgia
Receives: Other: Clinical assessment with standardized questionnaires
Healthy Control GroupAge range: 18 to 65 years No diagnosis of cervicogenic headache or chronic pain conditions Age- and sex-matched to the patient group Voluntary participation Exclusion criteria: illiteracy, refusal to participate, diabetes mellitus, hypothyroidism, chronic kidney disease, malignancy, neurological diseases associated with neuropathic pain, and rheumatic diseases such as rheumatoid arthritis, ankylosing spondylitis, or fibromyalgia
Receives: Other: Clinical assessment with standardized questionnaires

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Central Sensitization Inventory

    Description: A 25-item self-report questionnaire that evaluates symptoms associated with central sensitization, including hypersensitivity, sleep disturbance, and emotional complaints.

    Scoring: Total score range 0-100. A score of 40 or higher suggests the presence of central sensitization.

    Turkish validation and reliability study: Conducted in 2021

    Measured: At baseline

  2. PainDETECT Questionnaire

    Description: A self-administered screening tool for identifying neuropathic pain characteristics.

    Scoring: Total score range -1 to 38. Scores ≤12 indicate neuropathic pain is unlikely; scores ≥19 indicate neuropathic pain is likely; 13-18 indicates unclear classification.

    Turkish validation and reliability study: Conducted in 2013.

    Measured: At baseline.

Secondary outcomes (5)
  1. Headache Impact Test (6 items)

    Description: Measures the impact of headache on daily life, including pain severity, social functioning, and emotional well-being.

    Scoring: Total score range 36-78. Higher scores indicate greater impact. Severity cut-offs: ≤49 little or no impact; 50-55 some impact; 56-59 substantial impact; ≥60 severe impact.

    Turkish validation and reliability study: Conducted in 2021.

    Measured: At baseline

  2. Neck Disability Index

    Description: A 10-item questionnaire assessing how neck pain affects daily activities such as reading, working, and recreation.

    Scoring: Total score range 0-50, converted to percentage disability. Cut-off values: 0-4 no disability; 5-14 mild disability; 15-24 moderate disability; 25-34 severe disability; ≥35 complete disability.

    Turkish validation and reliability study: Conducted in 2009.

    Measured: At baseline

  3. Hospital Anxiety and Depression Scale

    Description: A 14-item scale with two subscales (7 for anxiety and 7 for depression).

    Scoring: Each subscale ranges 0-21. Higher scores reflect greater severity. Cut-offs: 0-7 normal, 8-10 borderline, ≥11 abnormal. Turkish validation and reliability study: Conducted in 1997.

    Measured: At baseline

  4. Jenkins Sleep Scale

    Description: A 4-item scale assessing sleep problems such as difficulty initiating or maintaining sleep and non-restorative sleep.

    Scoring: Total score range 0-20. Higher scores indicate poorer sleep quality. Turkish validation and reliability study: Conducted in 2018.

    Measured: At baseline

  5. Short Form-36 Health Survey

    Description: A 36-item instrument evaluating health-related quality of life across 8 domains: physical functioning, role limitations due to physical health, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health.

    Scoring: Each domain is scored 0-100, with higher scores indicating better quality of life.

    Turkish validation and reliability study: Conducted in 1999.

    Measured: At baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Dec 2025
  2. Study start3 Jul 2025
  3. Primary completion3 Oct 2025
  4. Study completion3 Oct 2025

Resources

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-control
Time perspective
Cross-sectional
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07292181
Sponsor's protocol ID
2025-GOKAEK-2513_2025.07.02_50
Status last verified
Dec 2025
First submitted
5 Dec 2025
Last updated
23 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data (IPD) underlying the results reported in this study will be shared. Researchers can request access to de-identified data necessary to reproduce the study findings.

Publications

  • Kocyigit, H., Turkish validity and reliability of short-form 36. Drug Treat, 1999. 12: p. 102-106.

  • Duruoz MT, Erdem D, Gencer K, Ulutatar F, Baklacioglu HS. Validity and reliability of the Turkish version of the Jenkins Sleep Scale in psoriatic arthritis. Rheumatol Int. 2018 Feb;38(2):261-265. doi: 10.1007/s00296-017-3911-2. Epub 2017 Dec 18.

    PubMed 29250729
  • Duzce Keles E, Birtane M, Ekuklu G, Kilincer C, Caliyurt O, Tastekin N, Is EE, Ketenci A, Neblett R. Validity and reliability of the Turkish version of the central sensitization inventory. Arch Rheumatol. 2021 Oct 18;36(4):518-526. doi: 10.46497/ArchRheumatol.2022.8665. eCollection 2021 Dec.

    PubMed 35382371
  • Alkan H, Ardic F, Erdogan C, Sahin F, Sarsan A, Findikoglu G. Turkish version of the painDETECT questionnaire in the assessment of neuropathic pain: a validity and reliability study. Pain Med. 2013 Dec;14(12):1933-43. doi: 10.1111/pme.12222. Epub 2013 Aug 7.

    PubMed 23924395
  • Aydemir, O., Hastane anksiyete ve depresyon olcegi Turkce formunun gecerlilik ve guvenilirligi. Turk Psikiyatri Derg., 1997. 8: p. 187-280.

  • Telci EA, Karaduman A, Yakut Y, Aras B, Simsek IE, Yagli N. The cultural adaptation, reliability, and validity of neck disability index in patients with neck pain: a Turkish version study. Spine (Phila Pa 1976). 2009 Jul 15;34(16):1732-5. doi: 10.1097/BRS.0b013e3181ac9055.

    PubMed 19770615
  • Dikmen PY, Bozdag M, Gunes M, Kosak S, Tasdelen B, Uluduz D, Ozge A. Reliability and Validity of Turkish Version of Headache Impact Test (HIT-6) in Patients with Migraine. Noro Psikiyatr Ars. 2020 Apr 24;58(4):300-307. doi: 10.29399/npa.24956. eCollection 2021.

    PubMed 34924791
  • Demir Karakilic G, Unluel H. Prevalence of clinical sensitization phenotype and neuropathic-like pain features in patients with cervicogenic headache: a case-control study. Neurol Res. 2026 Mar;48(3):402-417. doi: 10.1080/01616412.2026.2628609. Epub 2026 Feb 14.

    PubMed 41689387

Questions about this trial

What is this clinical trial studying?

An observational study of Cervicogenic Headache and Central Sensitization, run by Gulseren Demir Karakilic 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 5 inclusion and 8 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: finished, as of the sponsor's last update on 23 Dec 2025. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Central Sensitization Inventory (time frame: At baseline). The study lists 2 primary outcomes in all. 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 NCT07292181, which also lists 8 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 23 Dec 2025.

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