AzTrials
AzTrials

Neck PainNCT07462416

Central Sensitization and Clinical Parameters in Chronic Neck Pain

An observational study of Neck Pain and Central Nervous System Sensitization, run by Turkoglu Dr. Kemal Beyazit State Hospital 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
Search all trials

Trial summary

This study is a retrospective, cross-sectional observational study that assesses the correlations among central sensitization, pain, psychosocial factors, and temporomandibular function in patients with chronic neck pain. Read more about this study

Who is it for?
Ages 18 to 60 years
How many people
84 participants
Where
1 siteTurkey (Türkiye)
Study dates
5 Apr 2024to 18 Jan 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 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Study population: The study population includes patients living in Kahramanmaraş who have chronic neck pain. The sample consists of these patients who visited our clinic with this issue, received a diagnosis of chronic neck pain from a specialist, and agreed to take part in the study.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Türkoğlu Dr. Kemal Beyazıt State Hospital

    Kahramanmaraş, 46000

Other trials in Turkey (Türkiye)

About this study

Official title: 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

This study is a retrospective, cross-sectional observational study that assesses the correlations among central sensitization, pain, psychosocial factors, and temporomandibular function in patients with chronic neck pain. It underscores the importance of the biopsychosocial model in clinical practice and aims to improve understanding of central mechanisms in treatment planning. treatment planning.

Read the 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.
Keywords
Neck Pain, Central Sensitization, Catastrophization, Disability
Medical subject headings
Neck Pain, Temporomandibular Joint Dysfunction Syndrome, Chronic Pain

What is being measured

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

  1. Central Sensitization Inventory (CSI)

    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.

    Measured: At baseline (single time-point assessment)

  2. Visual Analog Scale (VAS)

    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.

    Measured: At baseline

Secondary outcomes (5)

  1. Pain Catastrophizing Scale (PCS)

    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.

    Measured: At baseline (single time-point assessment)

  2. Neck Disability Index

    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

    Measured: At baseline (single time-point assessment)

  3. Pittsburgh Sleep Quality Index (PSQI)

    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

    1. = Less than once a week
    2. = Once or twice a week
    3. = Three or more times a week

    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.

    Measured: At baseline (single time-point assessment)

  4. Jaw Functional Limitation Scale-20 (JFLS-20)

    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.

    Measured: At baseline

  5. Assessment of Pressure Pain Threshold

    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.

    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 posted10 Mar 2026
  2. Study start5 Apr 2024
  3. Primary completion17 Dec 2024
  4. Study completion18 Jan 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
Other
Time perspective
Cross-sectional
Enrolment
84 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07462416
Sponsor's protocol ID
TurkogluBeyazitSH
Status last verified
Mar 2026
First submitted
4 Mar 2026
Last updated
10 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • No publications yet

Questions about this trial

What is this clinical trial studying?

An observational study of Neck Pain and Central Nervous System Sensitization, run by Turkoglu Dr. Kemal Beyazit State 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 6 inclusion and 5 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 10 Mar 2026. 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 (CSI) (time frame: At baseline (single time-point assessment)). 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 NCT07462416, which also lists 1 linked publication.

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 10 Mar 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in