Relationship of Cervical Region Tension With Vagal Function

NCT05325879 | Completed

• 1 other identifier: HUSpine014
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Diseases; Autonomic Nervous System Disease

Keywords

vagus nerve; muscle tonus; Autonomic Nervous System Diseases; Pain Threshold

Outcome Measures

Primary Outcomes (3)

• Evaluation of Vagal Function

  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.

  10 minutes, in one assessment session

• Evaluation of SCM Muscle Tension

  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.

  10 minutes, in one assessment session.

• Hospital Anxiety and Depression Scale

  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

  10 minutes, in one assessment session

Secondary Outcomes (3)

• 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.

Study Arms (2)

Asymptomatic Individuals

ACTIVE COMPARATOR

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

Other: VAGUS-NDT

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.

Other: VAGUS-NDT

Interventions

VAGUS-NDT OTHER

Neurodynamic test for vagus nerve

Asymptomatic Individuals; Individuals with neck pain

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Yasemin Özel Aslıyüce

Ankara, Sıhhiye, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Gastrointestinal Diseases; Autonomic Nervous System Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases; Nervous System Diseases

Study Officials

• Utku Berberoğlu, MSc

  Hacettepe University

  STUDY CHAIR

• Özgün Uysal, MSc

  Hacettepe University

  STUDY CHAIR

• Özlem Ülger, Professor

  Hacettepe University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: April 6, 2022
• First Posted: April 13, 2022
• Study Start: August 15, 2022
• Primary Completion: September 15, 2023
• Study Completion: September 15, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)