Masseter Thickness, Bruxism, and Oral Behaviors in Chronic Neck Pain

NCT06874816 | Recruiting

• 1 other identifier: Beylikdüzüstateh14
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

A total of 30 patients aged 18-65 years who present with chronic non-specific neck pain and 30 healthy volunteers will be included in the study. Patients with symptoms persisting for at least 3 months will be eligible for inclusion. Necessary information will be provided to all participants, and informed consent will be obtained. To assess pain severity before treatment, participants will be asked to rate their complaints using the Visual Analog Scale (VAS), a linear scale for pain assessment. The Neck Disability Index will be used to determine the level of disability. The Jaw Functional Limitation Scale-20 (JFLS-20), Patient Health Questionnaire-9 (PHQ-9), Patient Health Questionnaire-15: Physical Symptoms, Generalized Anxiety Disorder-7 (GAD-7), and the Oral Behaviors Checklist-included in Axis 2 of the DC/TMD form developed for evaluating temporomandibular joint dysfunction-will be used to assess patients' psychosocial characteristics and parafunctional habits. Additionally, masseter muscle thickness will be evaluated using ultrasonographic measurement.

Conditions

Neck Pain

Outcome Measures

Primary Outcomes (1)

• Masseter Muscle Thickness

  Measured using ultrasonography, with values interpreted in relation to clinical findings. No fixed score range; thickness is recorded in millimeters.

  0 day

Secondary Outcomes (6)

• Visual Analog Scale (VAS)

  0 day

• Neck Disability Index

  0 day

• Patient Health Questionnaire-9 (PHQ-9)

  0 day

• Generalized Anxiety Disorder-7 (GAD-7)

  0 day

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

  0 day

Study Arms (2)

Neck pain group

Patients with chronic non specific neck pain

Healthy controls

Healthy controls

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population will consist of 30 patients diagnosed with chronic non-specific neck pain and 30 healthy volunteers, aged between 18 and 65 years.

You may qualify if:

• Diagnosed with chronic non-specific neck pain
• Aged between 18-65 years
• Symptoms persisting for at least 3 months

You may not qualify if:

• Pregnancy
• Presence of psychiatric or neurological diseases
• Use of psychiatric medications
• Cognitive impairment
• History of neck injection or surgery within the last 6 months
• Presence of rheumatic diseases
• Spinal stenosis
• Cervical disc herniation
• Advanced degeneration detected in radiological imaging
• History of fracture or surgery in the temporomandibular joint
• Presence of inflammatory, rheumatologic diseases, or malignancy affecting the t--emporomandibular joint

Sponsors & Collaborators

• Beylikduzu State Hospital: lead

Study Sites (1)

Beylikdüzü State Hospital

Istanbul, Beylikdüzü, 34147, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 8, 2025
• First Posted: March 13, 2025
• Study Start: March 10, 2025
• Primary Completion: April 10, 2025
• Study Completion: April 10, 2025
• Last Updated: March 26, 2025

Record last verified: 2025-03

Locations

TU (1)