NCT07462416

Brief 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. It underscores the importance of the biopsychosocial model in clinical practice and aims to improve understanding of central mechanisms in treatment planning. treatment planning.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2024

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

April 5, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 17, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 18, 2025

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 4, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 10, 2026

Completed
Last Updated

March 10, 2026

Status Verified

March 1, 2026

Enrollment Period

9 months

First QC Date

March 4, 2026

Last Update Submit

March 4, 2026

Conditions

Keywords

Neck PainCentral SensitizationCatastrophizationDisability

Outcome Measures

Primary Outcomes (2)

  • 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.

    At baseline (single time-point assessment)

  • 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.

    At baseline

Secondary Outcomes (5)

  • Pain Catastrophizing Scale (PCS)

    At baseline (single time-point assessment)

  • Neck Disability Index

    At baseline (single time-point assessment)

  • Pittsburgh Sleep Quality Index (PSQI)

    At baseline (single time-point assessment)

  • Jaw Functional Limitation Scale-20 (JFLS-20)

    At baseline

  • Assessment of Pressure Pain Threshold

    At baseline

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • \- 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.

You may not qualify if:

  • \- 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Türkoğlu Dr. Kemal Beyazıt State Hospital

Kahramanmaraş, 46000, Turkey (Türkiye)

Location

Related Publications (1)

  • No publications yet

    BACKGROUND

Related Links

MeSH Terms

Conditions

Neck PainTemporomandibular Joint Dysfunction SyndromeChronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsTemporomandibular Joint DisordersCraniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesMyofascial Pain SyndromesStomatognathic Diseases

Study Officials

  • Aysenur TUNCER, PT,PhD

    Independent researcher

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PT, Phd

Study Record Dates

First Submitted

March 4, 2026

First Posted

March 10, 2026

Study Start

April 5, 2024

Primary Completion

December 17, 2024

Study Completion

January 18, 2025

Last Updated

March 10, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
SAP
Time Frame
Start Date: 2026-06-01 End Date: 2031-06-01
Access Criteria
Data will be shared with researchers who submit a reasonable request describing the planned analyses and agree to use the data for research purposes only. A data use agreement may be required.
More information

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