## Protocol Section
### Identification Module
**NCT ID:** NCT06435364

**Brief Title:** Cervical Manual Therapy and Vagus Nerve Stimulation in Patients With Nonspecific Neck Pain

**Official Title:** Investigation of the Effect of Instrument Supported Cervical Manual Therapy Methods and Vagus Nerve Stimulation in Patients With Nonspecific Neck Pain

#### Organization Study ID Info
**ID:** E-10840098-202.3.02-2983
#### Organization
**Class:** OTHER
**Full Name:** Istanbul Medipol University Hospital
### Status Module
#### Completion Date
**Date:** 2024-08-21

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-30

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-06-15

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-17

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Istanbul Medipol University Hospital

#### Responsible Party

**Investigator Affiliation:** Istanbul Medipol University Hospital

**Investigator Full Name:** hazal genc

**Investigator Title:** Principal Investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** People with chronic neck pain are becoming more and more common in society every day.

**Detailed Description:** In chronic neck pain investigations, it is generally reported that all people experience neck pain once in my life and more than half of the developed societies experience this problem. It has been stated that 48% of these continue as chronic neck pain, which significantly affects the quality of life due to the postponement of treatment due to its cost.

### Conditions Module

**Conditions:**

- Pain Syndrome

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 50

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** This non-invasive system is activated by the cutaneous distribution of vagus nerve afferents via the external ear.

**Intervention Names:**

- Other: Vagus nerve stimilation

**Label:** Vagus nerve

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Manual therapy is effective in the treatment of musculoskeletal pain.

**Intervention Names:**

- Other: Manual therapy

**Label:** Manual therapy

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Vagus nerve

**Description:** This non-invasive system is activated by the cutaneous distribution of vagus nerve afferents through the external ear. Somatosensory innervation is provided by the auricular branch.

**Name:** Vagus nerve stimilation

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Manual therapy

**Description:** Manual therapy is mostly defined by the tissue targeted by the practitioner; it can be joint biased, muscle and connective tissue biased and/or neurovascular system biased techniques.

**Name:** Manual therapy

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Device is a heart rate sensor with the gold standard in high precision and accuracy that comes with a wearable chest strap. It can be connected to multiple training devices via Bluetooth and ANT+. The device features a soft, adjustable sensor that contacts the chest to capture heart rate in real time.

**Measure:** Autonomic nervous system device

**Time Frame:** 4 weeks

**Description:** The neck disability index is the most commonly used functional outcome tool for disabilities in the cervical region. This outcome assessment tool was created by modifying the Oswestry Disability Index and is highly reliable (Chad E. Cook, Amy E. Cook 2011).

Scoring is given for each question as A: 0 points, B: 1 point, C: 2 points, D: 3 points, E: 4 points, F: 5 points. The total score gives the test score. According to the test result 0-4=No disability 5-14= Mild disability 15-24= Moderate disability 25-34 = Severe disability

**Measure:** Neck disability index:

**Time Frame:** 4 weeks

**Description:** Range of motion is the ability of a joint to go through the full range of motion. The range of motion of a joint can be passive or active. Passive ROM - The maximum range of motion through which the joint can move with the aid of external force. Active ROM - the range of motion achieved by contracting and relaxing opposing muscles

**Measure:** Joint Range of Motion

**Time Frame:** 4 weeks

**Description:** The visual analogue scale (VAS) is a validated, subjective measure of acute and chronic pain. Scores are recorded by placing a handwritten mark on a 10 cm line representing the continuum between "no pain" and "worst pain"

**Measure:** The visual analogue scale (VAS)

**Time Frame:** 4 weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion criteria for volunteers and/or study participants;

* Presence of neck pain for at least three months
* Non-specific neck pain
* To have signed the voluntary consent form

Exclusion criteria for volunteers and/or participants;

* Having undergone surgery for the cervical region
* Rehabilitation of the neck area at least three months prior to treatment
* Traumatic medulla spinalis injury
* Neurological deficit
* Rheumatological disease
* Structural spinal disorders

**Maximum Age:** 60 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** hazaloksuz@gmail.com

**Name:** Hazal GENÇ, PhD

**Phone:** 05413204291

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Istanbul

**Contacts:**

***Contact 1:***

- **Email:** hazaloksuz@gmail.com

- **Name:** Hazal GENÇ, phd

- **Phone:** +905413204291

- **Role:** CONTACT

**Country:** Turkey

**Facility:** Bahçehir University

**Status:** RECRUITING

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010146

- Term: Pain

- ID: D000009461

- Term: Neurologic Manifestations

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

### Condition Browse Module - Browse Leaves

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M21485

- Name: Neck Pain

- Relevance: HIGH

- As Found: Neck Pain

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000019547

- Term: Neck Pain

### Misc Info Module

- Version Holder: 2024-05-31
