NCT07292181

Brief 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. 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

July 3, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 3, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 3, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 5, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 18, 2025

Completed
Last Updated

December 23, 2025

Status Verified

December 1, 2025

Enrollment Period

3 months

First QC Date

December 5, 2025

Last Update Submit

December 20, 2025

Conditions

Keywords

Headache DisordersNeck PainPain MechanismsPsychological DistressSleep QualityQuality of LifePain AssessmentCase-Control Study

Outcome Measures

Primary Outcomes (2)

  • 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

    At baseline

  • 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.

    At baseline.

Secondary Outcomes (5)

  • Headache Impact Test (6 items)

    At baseline

  • Neck Disability Index

    At baseline

  • Hospital Anxiety and Depression Scale

    At baseline

  • Jenkins Sleep Scale

    At baseline

  • Short Form-36 Health Survey

    At baseline

Study Arms (2)

Patient group

Age 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

Other: Clinical assessment with standardized questionnaires

Healthy Control Group

Age 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

Other: Clinical assessment with standardized questionnaires

Interventions

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.

Healthy Control GroupPatient group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yozgat Bozok University Faculty of Medicine, Department of Physical Medicine and Rehabilitation

Yozgat, Yozgat, 66100, Turkey (Türkiye)

Location

Related Publications (8)

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

    BACKGROUND
  • 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.

    PMID: 29250729BACKGROUND
  • 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.

    PMID: 35382371BACKGROUND
  • 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.

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

    BACKGROUND
  • 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.

    PMID: 19770615BACKGROUND
  • 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.

    PMID: 34924791BACKGROUND
  • 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.

MeSH Terms

Conditions

Post-Traumatic HeadacheNeuralgiaHeadache DisordersNeck PainSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, SecondaryBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesPeripheral Nervous System DiseasesNeuromuscular DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersMental Disorders

Study Officials

  • Gülseren Demir Karakılıç, Assistant Professor

    Yozgat Bozok University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor, Principal Investigator

Study Record Dates

First Submitted

December 5, 2025

First Posted

December 18, 2025

Study Start

July 3, 2025

Primary Completion

October 3, 2025

Study Completion

October 3, 2025

Last Updated

December 23, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
IPD and supporting documents will be shared upon request following the publication of the study and will be available for up to 5 years.
Access Criteria
De-identified IPD and supporting documents will be provided to researchers who submit a methodologically sound research proposal. Requests should be made via email to the corresponding author and, once approved, data will be shared through a secure file transfer.
More information

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