Central Sensitization and Neuropathic Pain in Cervicogenic Headache
NCT ID: NCT07292181
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
72 participants
OBSERVATIONAL
2025-07-03
2025-10-03
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
CROSS_SECTIONAL
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
Clinical assessment with standardized questionnaires
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 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
Clinical assessment with standardized questionnaires
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Clinical assessment with standardized questionnaires
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
65 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Gulseren Demir Karakilic
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Gulseren Demir Karakilic
Assistant Professor, Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Gülseren Demir Karakılıç, Assistant Professor
Role: PRINCIPAL_INVESTIGATOR
Yozgat Bozok University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Yozgat Bozok University Faculty of Medicine, Department of Physical Medicine and Rehabilitation
Yozgat, Yozgat, Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2025-GOKAEK-2513_2025.07.02_50
Identifier Type: -
Identifier Source: org_study_id