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临床试验/NCT05325879
NCT05325879已完成不适用

Investigation of the Relationship of Cervical Region Tension With Vagal Function and Gastrointestinal Symptoms

Hacettepe University2 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2022年8月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
41
试验地点
2
主要终点
Hospital Anxiety and Depression Scale

研究概览

简要总结

The increase in the tension of the soft tissues around a nerve restricts the movement, affects the function of the nerve, and makes the nerve vulnerable to entrapment. Even a mild nerve compression can cause entrapment and lead to neuroinflammation. It is known that inflammatory mediators amplify axonal sensitivity. Although the spontaneous discharge potential of visceral afferents is quite low under normal conditions, neuroinflammation increases the excitability of these fibers. With this mechanism, hyperalgesia may develop in sensory fibers in neuroinflammation. This may cause pathologies in the organs innervated by the relevant nerve.

The fascia and muscles of the cervical region surround the vagus nerve. There are two main fascial compartments in the cervical region. The SCM and trapezius muscle fascias join to the most superficial fascia of the deep cervical fascia and they together form these compartments. These fasciae superiorly attach to the cranium and inferiorly to the pectoral region. The vagus nerve emerges from the jugular foramen together with the 9th and 11th cranial nerves. It then continues through the carotid sheath in the cervical region. The carotid sheath is in contact with the SCM muscle. For this reason, it can be thought that SCM muscle tension or thickness may affect the carotid sheath and thus the function of the vagus nerve passing through it.

In summary, deterioration in vagus nerve activity plays a role in pathologies of the organs innervated by the vagus. Although the relationship between vagal dysfunction and gastrointestinal system symptoms is clear, the mechanisms affecting vagus nerve function have not yet been clarified. It has been reported in the literature that some maneuvers from the cervical region are also effective on the vagus nerve. Also, according to investigators' clinical experience, gastrointestinal symptoms are frequently observed in patients with increased cervical soft tissue tension. However, there are not enough studies investigating whether the cervical region soft tissue tension can affect the gastrointestinal system via the vagus nerve. Therefore, this study was planned to examine the relationship of cervical soft tissue tension with vagus nerve function and gastrointestinal symptoms in asymptomatic individuals and individuals with neck pain.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Screening
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Being 18-50 of age,
  • Having less than 30 body mass index,
  • Being a volunteer

排除标准

  • Having any type of malign disease,
  • Being diagnosed with a systemic disease (cardiologic, gastrointestinal, rheumatological, neurological, etc.),
  • Having any type of surgery within the last 6 months,
  • Being diagnosed with Whiplash syndrome
  • Having an unhealed fracture
  • Pregnancy
  • Using prescribed medicine for the gastrointestinal system

结局指标

主要结局

Hospital Anxiety and Depression Scale

时间窗: 10 minutes, in one assessment session

Hospital Anxiety and Depression Scale was developed by Zigmond and Snaith, and the Turkish version of the scale was published by Aydemir et al. The scale consists of 14 items, 7 of which assess anxiety and 7 of which assess depression symptoms. It is a 4-point Likert scale type and is scored between 0-3. A high score indicates high levels of anxiety and depression

Evaluation of Vagal Function

时间窗: 10 minutes, in one assessment session

Vagus nerve function will be evaluated with the Vagus Neurodynamic Test (VAGUS-NDT). Carta et al. VAGUS-NDT, which was validated and reliable in 2020, evaluates vagal function selectively. The test is performed with the patient in the supine position. The test is considered positive if unpleasant sensations are described when pressure is applied to the abdomen after the head is placed in cervicocranial flexion, lateral flexion, and rotation.

Evaluation of SCM Muscle Tension

时间窗: 10 minutes, in one assessment session.

SCM muscle tension will be performed with Myoton-3 (Muomeetria AS, Tallinn, Estonia) myometer. Myometer is a high validity and reliability method used to evaluate muscle tension. During the measurement, the device will give the tension of the muscle numerically by making a light touch on the skin. For the measurement, the myotone will be placed perpendicular to the midpoint between the anterior surface of the manubrium sterni and the mastoid process of the temporal bone, and an average of 10 measurements will be used.

次要结局

  • Evaluation of Neck Disability(5 minutes, in one assessment session.)
  • Evaluation of Gastrointestinal Symptoms(5 minutes, in one assessment session.)
  • Evaluation of Pain Intensity(1 minutes, in one assessment session.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yasemin Özel Aslıyüce

Research Assistant

Hacettepe University

研究点 (2)

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