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临床试验/NCT07468786
NCT07468786尚未招募不适用

Comparison of Masseter Muscle Thickness Measured by Ultrasonography in Individuals With Chronic Neck Pain Compared to Healthy Individuals

Hasan Kalyoncu University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2026年3月20日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
90
试验地点
1
主要终点
Ultrasonographic Measurement

研究概览

简要总结

The primary objective of our study is to compare the thickness of the masseter muscle, measured by ultrasound, in individuals with chronic neck pain to that of healthy individuals. The secondary objective of the study is to examine the relationships between masseter muscle thickness and pain intensity, neck disability level, pain catastrophizing level, and clinical diagnostic criteria in individuals with chronic neck pain.

详细描述

The aim of this study is to evaluate masseter muscle thickness in individuals with chronic neck pain using ultrasonography and to compare it with healthy individuals. Thus, it is intended to reveal possible morphological changes related to the craniomandibular system in chronic neck pain and to determine whether these changes contribute to clinical evaluations. The literature reports that there are biomechanical and neuromuscular connections between the temporomandibular system and the cervical spine, and that changes in masseter muscle activity and morphology may be related to neck pain. The literature emphasizes that there are biomechanical, neuromuscular, and sensory connections between the temporomandibular system and the cervical spine, and that dysfunctions in these two regions may influence each other reciprocally. The masseter muscle, in particular, being one of the primary muscles of the temporomandibular system, may exhibit increased muscle activity, parafunctional habits, and morphological adaptations due to central sensitization mechanisms in chronic pain conditions. Chronic neck pain is reported to be more common in individuals with temporomandibular disorders, along with increased muscle sensitivity and functional limitations, and this condition is associated with cervical pain severity and disability level. Ultrasonography is a reliable, valid, and non-invasive method for assessing muscle thickness and is widely used to evaluate the morphological characteristics of the masseter muscle. Measuring masseter muscle thickness by ultrasonography allows for the evaluation of the muscle's structural response to functional loading and enables comparisons between different clinical groups. However, the literature shows that studies comparing possible changes in masseter muscle thickness in individuals with chronic neck pain with healthy individuals are limited, and this relationship has not been sufficiently elucidated. Accordingly, the primary objective of this study is to compare the masseter muscle thickness measured by ultrasonography in individuals with chronic neck pain with that in healthy individuals. The secondary objective of the study is to examine the relationships between masseter muscle thickness and pain intensity, neck disability level, pain catastrophizing level, and clinical diagnostic criteria in individuals with chronic neck pain.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Be between the ages of 18 and 45
  • Have neck pain that has persisted for at least 3 months
  • Agree to participate in the study voluntarily and provide written informed consent

排除标准

  • History of cervical spine surgery or severe trauma
  • Diagnosis of cervical radiculopathy, myelopathy, or neurological disease
  • Rheumatic, inflammatory, or systemic musculoskeletal diseases
  • Diagnosed temporomandibular joint disorder (TMD)
  • Diagnosis of bruxism or a pronounced habit of teeth clenching/grinding
  • History of manual therapy, injection, or surgical intervention in the face, jaw, or neck region within the last 6 months
  • Currently undergoing orthodontic treatment or history of orthodontic treatment within the last 6 months
  • Cognitive impairment or conditions that prevent understanding and responding to questionnaires

研究组 & 干预措施

Chronic neck pain group

The study will include individuals aged 18-45 who have experienced neck pain for at least 3 months but do not have a diagnosed cervical pathology.

Healthy Group

The control group will also include individuals aged 18-45 with no health problems.

结局指标

主要结局

Ultrasonographic Measurement

时间窗: through of the study, average 3 months

Masseter muscle thickness will be assessed using the B-mode ultrasound method with a 7.5-10 MHz frequency linear probe on an ALEXUS brand ultrasound device. During measurements, participants will be positioned sitting upright, with the head in a neutral position and the jaw at rest (teeth not in occlusion). Prior to measurement, participants will be instructed to avoid activities such as intense chewing or gum chewing for the last 24 hours. The measurement point will be determined as the midpoint of the line between the zygomatic arch and the mandibular angle. The linear probe will be placed parallel to the long axis of the masseter muscle fibers, perpendicular to the skin surface, and with minimal pressure applied. The ultrasound image will clearly distinguish the skin, subcutaneous tissue, and superficial and deep fascial borders of the masseter muscle.

次要结局

  • Visual Analog Scale (VAS)(through of the study, average 3 months)
  • Neck Disability Index - NDI(through of the study, average 3 months)
  • Pain Catastrophizing Scale(through of the study, average 3 months)
  • Northwick Park Neck Pain Questionnaire (NPQ)(through of the study, average 3 months)

研究者

发起方
Hasan Kalyoncu University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tuğba GÖNEN

Asisst. Prof. Dr.

Hasan Kalyoncu University

研究点 (1)

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