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NCT Number: NCT06874816

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

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Beylikdüzü State Hospital

Istanbul, Beylikdüzü, 34147, Turkey (Türkiye)

Location status: Recruiting

Location contact

Büşra Şirin

CONTACT

[email protected]

02124443322

Büşra Şirin Ahısha, MD

PRINCIPAL_INVESTIGATOR

Nurdan Paker, Prof

SUB_INVESTIGATOR

Who can participate

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

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Masseter Muscle Thickness

    Time frame: 0 day

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

Secondary outcomes

  1. Visual Analog Scale (VAS)

    Time frame: 0 day

    A linear scale used to assess pain severity, where higher scores indicate more severe pain. Score range: 0-10.

  2. Neck Disability Index

    Time frame: 0 day

    A questionnaire used to evaluate the level of disability related to neck pain, with higher scores reflecting greater disability. Score range: 0-100.

  3. Patient Health Questionnaire-9 (PHQ-9)

    Time frame: 0 day

    A scale measuring the severity of physical symptoms, where higher scores represent greater somatic symptom burden. Score range: 0-30.

  4. Generalized Anxiety Disorder-7 (GAD-7)

    Time frame: 0 day

    A scale used to assess anxiety levels, with higher scores indicating more severe anxiety symptoms. Score range: 0-21.

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

    Time frame: 0 day

    A tool used to evaluate functional limitations of the jaw, where higher scores indicate greater impairment. Score range: 0-100.

  6. Oral Behaviors Checklist

    Time frame: 0 day

    A questionnaire used to identify parafunctional oral habits, with higher scores reflecting more frequent parafunctional activities. No predefined score range; higher scores indicate greater frequency.

Sponsors and collaborators

Lead sponsor

Beylikduzu State Hospital

Other

Registry information

Official study title

Does Your Jaw Tell the Story of Your Pain? Masseter Muscle Thickness, Bruxism, and Oral Behaviors in Chronic Non-Specific Neck Pain

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 13, 2025
Registry last updated
Mar 26, 2025

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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