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NCT Number: NCT07462416

Central Sensitization and Clinical Parameters in Chronic Neck Pain

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Central Sensitization Inventory (CSI)

    Time frame: At baseline (single time-point assessment)

    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.

  2. Visual Analog Scale (VAS)

    Time frame: At baseline

    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.

Secondary outcomes

  1. Pain Catastrophizing Scale (PCS)

    Time frame: At baseline (single time-point assessment)

    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.

  2. Neck Disability Index

    Time frame: At baseline (single time-point assessment)

    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

  3. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: At baseline (single time-point assessment)

    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

    • = Less than once a week
    • = Once or twice a week
    • = 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.

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

    Time frame: At baseline

    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.

  5. Assessment of Pressure Pain Threshold

    Time frame: At baseline

    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.

Sponsors and collaborators

Lead sponsor

Turkoglu Dr. Kemal Beyazit State Hospital

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Mar 10, 2026
Registry last updated
Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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