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Clinical Trials/NCT05325879
NCT05325879CompletedNot Applicable

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

Hacettepe University1 site in 1 country41 target enrollmentStarted: August 15, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
41
Locations
1
Primary Endpoint
Hospital Anxiety and Depression Scale

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Screening
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 50 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

  • •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

Arms & Interventions

Asymptomatic Individuals

Active Comparator

Individuals aged between 18-50 who volunteered to participate in the study, will form the control group.

Intervention: VAGUS-NDT (Other)

Individuals with neck pain

Experimental

Individuals with neck pain aged between 18-50 who volunteered to participate in the study, will form the study group.

Intervention: VAGUS-NDT (Other)

Outcomes

Primary Outcomes

Hospital Anxiety and Depression Scale

Time Frame: 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

Time Frame: 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

Time Frame: 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.

Secondary Outcomes

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

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Yasemin Özel Aslıyüce

Research Assistant

Hacettepe University

Study Sites (1)

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