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Effect of Auricular Vagus Stimulating in Non Specific Chronic Neck Pain

Primary Purpose

Neck Pain, Vagus, Autonomic Nervous System

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Vagus stimulation
Consevative treatment
Sponsored by
Okan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)Does not accept healthy volunteers

Inclusion Criteria:

  • 18-65 years old
  • people with non-specific neck pain

Exclusion Criteria:

  • Who has neurological problems,
  • who has vision and hearing loss,
  • who has a tumor and infection in the cervical region,
  • who has undergone surgery related to the cervical region,
  • who has had a cervical streroid injection in the last 3 months

Sites / Locations

  • Emine Atıcı

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Control Group

Vagus Stimulation Group

Arm Description

Conservative treatment

Vagus Stimulation Group

Outcomes

Primary Outcome Measures

Pain Severity
Pain severity Within the scope of this study, a Visual Analog Scale was applied, with both ends marked between 0 and 10, 100 mm long and marked every 10 mm; the patient was marked according to his own pain level, scored between 0-10. Deciphered. Deciphered. The Visual Analogue Scale was applied. 0 was rated as "no pain" and 10 as "unbearable level of pain"
Muscle strength Measurement
Muscle strength was measured with La Fayette brand digital hand dynamometer. Flexion, extension, right and left lateral flexion of the neck were measured with the device. The patients were fixed to the stretcher with T3 and spina iliac superior ventro tapes. Each movement measurement was repeated 3 times at December intervals of 15 seconds
Joint Range of Motion Measurement
Neck region flexion, extension, right and left lateral flexion joint range of motion was evaluated by climatometer. The tests were performed in a back-supported chair. While the phone application called Goniometer was open, the evaluation was performed by placing it in a vertical position in front of the ear for flexion and extension measurements, and by placing the measurement line on the side that was not measured so as not to prevent movement in lateral flexion measurements, so that the measurement line was flush with the eyes. Rotation movements were measured by placing the phone on the person's head to follow the nose alignment. The ROM value was taken as the average of the 3 active movement spans made by the individuals after the movement made passively once by the physiotherapist.
Assessment of dysability
The level of chronic neck pain affecting daily life activities was assessed by the Neck Disability Index (NDI). The validity of this index in Turkish was made by Telci et al. Neck Disability Index consists of 10 items and Article 4 of subjective symptoms (pain intensity, headache, concentration, sleep) substance other 6 activities of daily living (personal care, lifting, reading, business, car handling and leisure pursuits) is related to.The classification of disability according to neck disability index score is as follows; 0-4: no disability, 5-14: mild disability, 15-24: moderate disability, 25-34: severe disability, >34: full disability.
Evaluation of sleep quality
Pittsburgh sleep quality index, Agargün et al. it is turkified by. The index is a 19-item self-report that evaluates sleep disturbance and quality in the last one-month period. it consists of 24 questions, 19 questions are self-report questions, 5 questions are answered by a spouse or roommate. The 18 scored questions of the scale consist of 7 components. These are subjective sleep quality, sleep duration, sleep latency, sleep disturbance, habitual sleep activity, use of sleeping pills, and daytime dysfunction.The global score obtained ranges from 0-21, and high values indicate that the quality of sleep is poor Decently, the level of sleep disturbance is high. A global score of 5 or above indicates that the quality of sleep is clinically significantly poor.

Secondary Outcome Measures

Full Information

First Posted
August 25, 2022
Last Updated
September 1, 2022
Sponsor
Okan University
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1. Study Identification

Unique Protocol Identification Number
NCT05527366
Brief Title
Effect of Auricular Vagus Stimulating in Non Specific Chronic Neck Pain
Official Title
The Effect of Auricular Vagus Stimulating on Pain, Disability and Sleep in Non Specific Chronic Neck Pain
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
August 2, 2021 (Actual)
Primary Completion Date
March 30, 2022 (Actual)
Study Completion Date
March 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Okan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of our study is to compare the efects of conventional treatment and vagus nerve stimulation on pain, normal joint movement, disability and sleep in non-specific chronic neck pain. 36 patients aged between 18 and 65 years with non-specific neck pain participated in our randomly planned study. All these patients were divided into 2 groups. Demographic and physical characteristics of the patients were recorded. The first group was treated with auricular vagus nerve stimulation. Conservatire treatment that consists of hotpack, transcutaneous electrical nerve stimulation (TENS) and therapeutic ultrasound was applied to the second group. In addition to their treatment, some home exercises were given and tought. Pain was assessed with a visual analog scale (VAS). Muscle strength was evalvated with a digital hand dynamometer. Neck normal joınt motion was evaluated with goniometer clinometer which is a mobile phone application. While disability was mensured with the neck disability index, sleep quality was evalvated with the Pittsburg sleep questionnaire. All the measurements were recorded before the trearment and after the 15 session treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain, Vagus, Autonomic Nervous System

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Experimental
Arm Description
Conservative treatment
Arm Title
Vagus Stimulation Group
Arm Type
Experimental
Arm Description
Vagus Stimulation Group
Intervention Type
Other
Intervention Name(s)
Vagus stimulation
Intervention Description
The Vagus Stimulation Group received auricular vagus stimulation for a total of 15 sessions of 25 minutes 5 days a week. The patients were applied with vagustim device consisting of TENS device with electrodes placed bilaterally in the outer ear with headphones that can be selected according to ear size. During the application, the gel was used to avoid causing any damage and to ensure conductivity. It is placed so that tragus and konkaya are facing. The pulse duration of the TENS device is less than 500 microseconds, the frequency is 10 Herzt, the module was applied in TENS mode and in the form of a biphasic asymmetric wave.
Intervention Type
Other
Intervention Name(s)
Consevative treatment
Intervention Description
A total of 15 sessions 5 days a week, 20 minutes of hotpack, 20 minutes of TENS, 5 minutes of 1,3 watt/cm2 ultrasound consisting of a total of 25 minutes of treatment was applied to the neck area.
Primary Outcome Measure Information:
Title
Pain Severity
Description
Pain severity Within the scope of this study, a Visual Analog Scale was applied, with both ends marked between 0 and 10, 100 mm long and marked every 10 mm; the patient was marked according to his own pain level, scored between 0-10. Deciphered. Deciphered. The Visual Analogue Scale was applied. 0 was rated as "no pain" and 10 as "unbearable level of pain"
Time Frame
3-week change in pain intensity
Title
Muscle strength Measurement
Description
Muscle strength was measured with La Fayette brand digital hand dynamometer. Flexion, extension, right and left lateral flexion of the neck were measured with the device. The patients were fixed to the stretcher with T3 and spina iliac superior ventro tapes. Each movement measurement was repeated 3 times at December intervals of 15 seconds
Time Frame
3-week change in muscle strength
Title
Joint Range of Motion Measurement
Description
Neck region flexion, extension, right and left lateral flexion joint range of motion was evaluated by climatometer. The tests were performed in a back-supported chair. While the phone application called Goniometer was open, the evaluation was performed by placing it in a vertical position in front of the ear for flexion and extension measurements, and by placing the measurement line on the side that was not measured so as not to prevent movement in lateral flexion measurements, so that the measurement line was flush with the eyes. Rotation movements were measured by placing the phone on the person's head to follow the nose alignment. The ROM value was taken as the average of the 3 active movement spans made by the individuals after the movement made passively once by the physiotherapist.
Time Frame
3-week change in Range of motion
Title
Assessment of dysability
Description
The level of chronic neck pain affecting daily life activities was assessed by the Neck Disability Index (NDI). The validity of this index in Turkish was made by Telci et al. Neck Disability Index consists of 10 items and Article 4 of subjective symptoms (pain intensity, headache, concentration, sleep) substance other 6 activities of daily living (personal care, lifting, reading, business, car handling and leisure pursuits) is related to.The classification of disability according to neck disability index score is as follows; 0-4: no disability, 5-14: mild disability, 15-24: moderate disability, 25-34: severe disability, >34: full disability.
Time Frame
3-week change in dysability
Title
Evaluation of sleep quality
Description
Pittsburgh sleep quality index, Agargün et al. it is turkified by. The index is a 19-item self-report that evaluates sleep disturbance and quality in the last one-month period. it consists of 24 questions, 19 questions are self-report questions, 5 questions are answered by a spouse or roommate. The 18 scored questions of the scale consist of 7 components. These are subjective sleep quality, sleep duration, sleep latency, sleep disturbance, habitual sleep activity, use of sleeping pills, and daytime dysfunction.The global score obtained ranges from 0-21, and high values indicate that the quality of sleep is poor Decently, the level of sleep disturbance is high. A global score of 5 or above indicates that the quality of sleep is clinically significantly poor.
Time Frame
3-week change in sleep quality

10. Eligibility

Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18-65 years old people with non-specific neck pain Exclusion Criteria: Who has neurological problems, who has vision and hearing loss, who has a tumor and infection in the cervical region, who has undergone surgery related to the cervical region, who has had a cervical streroid injection in the last 3 months
Facility Information:
Facility Name
Emine Atıcı
City
Tuzla
State/Province
İstanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Auricular Vagus Stimulating in Non Specific Chronic Neck Pain

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