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临床试验/NCT06874816
NCT06874816招募中不适用

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

Beylikduzu State Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年3月10日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
Masseter Muscle Thickness

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

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

排除标准

  • •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

结局指标

主要结局

Masseter Muscle Thickness

时间窗: 0 day

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

次要结局

  • 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)
  • Oral Behaviors Checklist(0 day)

研究者

发起方
Beylikduzu State Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Busra Sirin

MD

Beylikduzu State Hospital

研究点 (1)

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