Gastrointestinal DiseasesNCT05325879
Relationship of Cervical Region Tension With Vagal Function
A study testing VAGUS-NDT in people with Gastrointestinal Diseases and Autonomic Nervous System Disease, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Diseases, Autonomic Nervous System Disease
- What is being tested?
- VAGUS-NDT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Aug 2022to 15 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being 18-50 of age,
- Having less than 30 body mass index,
- Being a volunteer
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Relationship of Cervical Region Tension With Vagal Function and Gastrointestinal Symptoms
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.
- Being tested
- VAGUS-NDT
- Keywords
- vagus nerve, muscle tonus, Autonomic Nervous System Diseases, Pain Threshold
- Medical subject headings
- Gastrointestinal Diseases, Autonomic Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VAGUS-NDTOther
Neurodynamic test for vagus nerve
| Study group | Role | What they receive |
|---|---|---|
| Asymptomatic Individuals | Active comparator | Individuals aged between 18-50 who volunteered to participate in the study, will form the control group. Receives: 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. Receives: Other: VAGUS-NDT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 10 minutes, in one assessment session
Secondary outcomes (3)
Evaluation of Neck Disability
The level of neck disability will be evaluated using the The Neck Disability Questionnaire. It was developed by Vernon et al. as a neck version of the Oswestry Low Back Pain Scale. Within the scope of this study, the Neck Disability Questionnaire will be applied to the participants with a neck pain severity of 3 and above on the Numerical Pain Rating Scale. The Neck Disability Questionnaire includes ten questions about pain, personal care, concentration, work, driving, and sleeping. Each question is scored between 0-5 points. The total score is evaluated out of 50. A high score means a high disability.
Measured: 5 minutes, in one assessment session.
Evaluation of Pain Intensity
Pain intensity will be assessed using the Numerical Pain Rating Scale. The 11-item version of the scale, which is frequently used to measure the severity of pain in adults, will be used. Within the scope of this study, a scale will be used to measure the severity of neck pain of the participants. With this scale, participants will be asked to measure their neck pain on a scale of 0-10. A value of '0' indicates no pain and a value of '10' indicates excruciating pain.
Measured: 1 minutes, in one assessment session.
Evaluation of Gastrointestinal Symptoms
Gastrointestinal symptoms will be evaluated using the Gastrointestinal Symptoms Rating Scale. Revicki et al. The scale developed by CBS measures common symptoms in CBS diseases. A seven-point Likert-type scale consisting of 15 items consisting of five sub-dimensions was made in order. These sub-dimensions are; reflux, indigestion, diarrhea, constipation and abdominal pain. The total score ranges from 15 to 105, with a high score indicating severe symptoms.
Measured: 5 minutes, in one assessment session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2022
- Study start15 Aug 2022
- Primary completion15 Sep 2023
- Study completion15 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal DiseasesStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasemin Özel Aslıyüce, Hacettepe University
- Investigators
- Utku Berberoğlu, MSc, Study chair, Hacettepe UniversityÖzgün Uysal, MSc, Study chair, Hacettepe UniversityÖzlem Ülger, Professor, Study director, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05325879
- Sponsor's protocol ID
- HUSpine014
- Status last verified
- Nov 2023
- First submitted
- 6 Apr 2022
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Relationship of Cervical Region Tension With Vagal Function and Gastrointestinal Symptoms
- ClinicalTrials.gov ID
- NCT05325879
- Acronym / sponsor ID
- HUSpine014
- Keywords
- vagus nerve, muscle tonus, Autonomic Nervous System Diseases, Pain Threshold
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 15 Sep 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 13 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Asymptomatic Individuals | Active comparator | Other: VAGUS-NDTIndividuals aged between 18-50 who volunteered to participate in the study, will form the control group. |
| Individuals with neck pain | Experimental | Other: VAGUS-NDTIndividuals with neck pain aged between 18-50 who volunteered to participate in the study, will form the study group. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Being 18-50 of age,
- Having less than 30 body mass index,
- Being a volunteer
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VAGUS-NDTNeurodynamic test for vagus nerve | Other | Asymptomatic Individuals, Individuals with neck pain |
Primary outcome
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.
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
3 secondary outcomes
Evaluation of Neck Disability
Time frame: 5 minutes, in one assessment session.
Evaluation of Pain Intensity
Time frame: 1 minutes, in one assessment session.
Evaluation of Gastrointestinal Symptoms
Time frame: 5 minutes, in one assessment session.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Utku Berberoğlu, MSc study chair
Hacettepe University
Özgün Uysal, MSc study chair
Hacettepe University
Özlem Ülger, Professor study director
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VAGUS-NDT in people with Gastrointestinal Diseases and Autonomic Nervous System Disease, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of Vagal Function (time frame: 10 minutes, in one assessment session). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023; AzTrials last refreshed its copy on 6 Nov 2026.