- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07462416
Central Sensitization and Clinical Parameters in Chronic Neck Pain
Correlation of Central Sensitization With Pain, Pain Catastrophizing, Disability, Sleep Quality, and Jaw Function in Patients With Chronic Neck Pain: A Retrospective, Cross-Sectional Study
Study Overview
Status
Detailed Description
Chronic neck pain is a widespread health issue globally that negatively impacts quality of life. In some patients, pain cannot be explained solely by tissue damage; increased sensitivity of the central nervous system (central sensitization) may contribute to the persistence of pain.
The aim of this study is to explore the relationship between the level of central sensitization and the following parameters in individuals with chronic neck pain:
- Pain intensity
- Pressure pain threshold
- Pain catastrophizing level
- Neck-related disability
- Sleep quality
- Jaw function
The study has a retrospective, cross-sectional design. Records of patients previously evaluated in the clinic will be analyzed. No new interventions will be conducted on participants. The study is observational in nature.
This research aims to:
- Enhance understanding of the clinical significance of central sensitization in chronic neck pain
- Contribute to the development of multidisciplinary treatment strategies
- Support the management of patients through more personalized treatment plans.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Kahramanmaraş, Turkey (Türkiye), 46000
- Türkoğlu Dr. Kemal Beyazıt State Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients aged 18-60 years
Patients with neck pain lasting at least 3 months.
Patients with a pain intensity of 4 or higher on the Visual Analog Scale (VAS).
Patients with a Pain Catastrophizing Scale (PCS) score greater than 30.
Patients with a Central Sensitization Inventory (CSI) score greater than 30.
Patients who have not received physiotherapy or manual therapy in the past 3 months.
Exclusion Criteria:
- Individuals with a history of neck or spinal surgery.
Patients with a history of whiplash injury or fracture.
Individuals with unstable neurological findings.
Presence of cervical pathology such as herniation or nerve root compression.
Regular use of analgesic or anti-inflammatory medications.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Central Sensitization Inventory (CSI)
Time Frame: At baseline (single time-point assessment)
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Central sensitization was assessed using the CSI, a tool applicable in cases of chronic pain.
The CSI has two parts.
Part A evaluates symptoms and is scored from 0 to 100; higher scores reflect greater central sensitization.
A score of 30 or higher suggests the presence of central sensitization.
Part B asks if the individual has ever been diagnosed with any central sensitization syndromes.
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At baseline (single time-point assessment)
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Visual Analog Scale (VAS)
Time Frame: At baseline
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Pain intensity will be assessed using the Visual Analog Scale (VAS).
The VAS is commonly employed in clinical practice because it is simple to use and consistent.
The scale ranges from 0 to 10, where "0" indicates no pain and "10" signifies the worst possible pain.
Patients are informed that pain severity increases from 0 to 10 and are asked to mark the number that best reflects their pain level.
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At baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Catastrophizing Scale (PCS)
Time Frame: At baseline (single time-point assessment)
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Pain catastrophizing was measured with the PCS.
This 13-item self-report questionnaire includes three subscales: rumination, magnification, and helplessness.
Higher scores indicate more pain and greater functional impairment, with a total score above 30 signifying a clinically significant level of pain catastrophizing.
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At baseline (single time-point assessment)
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Neck Disability Index
Time Frame: At baseline (single time-point assessment)
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Participants' neck disability levels were evaluated using the Neck Disability Index (NDI). The scale includes 10 items that address neck pain intensity, personal care, lifting, reading, headaches, concentration, driving, sleep, and recreational activities. Each item is scored from 0 to 5. The total score ranges from 0 to 50, with higher scores indicating greater disability. Disability levels are classified as follows: 0-4: No disability 5-14: Mild disability 15-24: Moderate disability 25-34: Severe disability 35 and above: Complete disability |
At baseline (single time-point assessment)
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Pittsburgh Sleep Quality Index (PSQI)
Time Frame: At baseline (single time-point assessment)
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Sleep quality was measured using the Pittsburgh Sleep Quality Index (PSQI). The PSQI was created by Buysse et al. in 1989. The scale's validity and reliability in Turkish were tested by Agargün et al. in 1996. The questionnaire features 24 items related to both nighttime and daytime sleep. Nineteen items are self-rated, while five are answered by a bed partner or roommate. The five partner-rated items and the question asking whether the person has a sleep partner or roommate are not included in the scoring. Responses are rated on a 0-3 scale: 0 = Not during the past month
Eighteen of the 24 items are scored, resulting in a total score from 0 to 21. A score of 5 or below indicates good sleep quality, while a score above 5 suggests poor sleep quality. |
At baseline (single time-point assessment)
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Jaw Functional Limitation Scale-20 (JFLS-20)
Time Frame: At baseline
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The Jaw Functional Limitation Scale-20 (JFLS-20) will be used to assess the level of temporomandibular joint function in individuals. The JFLS-20 is a questionnaire designed to measure disability in people with temporomandibular disorders. Each item is scored on a scale from 0 to 10, where 0 indicates no limitation and 10 indicates severe limitation. The total score ranges from 0 to 200, with higher scores indicating greater impairment. The JFLS-20 is a valid and reliable tool for clinical use. |
At baseline
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Assessment of Pressure Pain Threshold
Time Frame: At baseline
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Pressure pain sensitivity will be assessed using a digital pressure pain threshold (PPT) algometer (Wagner Instruments, Greenwich, USA).
Measurements will be taken bilaterally from the upper trapezius, sternocleidomastoid, masseter, and temporalis muscles.
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At baseline
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Collaborators and Investigators
Investigators
- Study Director: Aysenur TUNCER, PT,PhD, Independent researcher
Publications and helpful links
General Publications
- No publications yet
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Musculoskeletal Diseases
- Stomatognathic Diseases
- Muscular Diseases
- Joint Diseases
- Jaw Diseases
- Mandibular Diseases
- Craniomandibular Disorders
- Myofascial Pain Syndromes
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Temporomandibular Joint Disorders
- Chronic Pain
- Temporomandibular Joint Dysfunction Syndrome
- Neck Pain
Other Study ID Numbers
- TurkogluBeyazitSH
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
De-identified individual participant data from this study will be available to qualified researchers upon reasonable request. The shared data will include anonymized clinical and questionnaire results used in this study.
Requests can be directed to the corresponding author, Dr. Süreyya Damar-Örenler (email: fztsureyya88@otmail.com). Data sharing will adhere to applicable ethical and privacy regulations.
IPD Sharing Time Frame
Start Date: 2026-06-01
End Date: 2031-06-01
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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