Efficacy of Auricular Vagus Nerve Stimulation and Electrotherapy Modalities in Patients With Chronic Low Back Pain

Comparison of the Efficacy of Auricular Vagus Nerve Stimulation and Electrotherapy Modalities in Chronic Low Back Pain

The aim of our study is to compare the effectiveness of auricular vagus nerve stimulation and conventional physical therapy in patients with Chronic Low Back Pain (CBA). 60 patients, aged between 18 and 60, with persistent low back pain for the last 3 months and who voluntarily agreed to participate in the study will be included in the study. Patients will be randomly divided into two groups as conventional therapy (Group I) and auricular vagus stimulation therapy (Group II). Patient Identification Form, Oswestry Disability Index, Lumbal Region Joint Range of Motion and Mobility (Inclinometer, Modified Schober Test, Hand Finger-Ground Distance Test), muscle strength (CSMI-Cybex Humac-Norm isokinetic dynamometer and Lafayette manual muscle strength measuring device) in the evaluation of patients with CKD and endurance tests, postural control and balance assessment (BBS, Biodex Medical Systems), Visual Analogue Scale (VAS), Beck Depression Inventory (BDI), Pittsburgh Sleep Quality Scale (PUKÖ). After the measurements on the 1st day, 15 sessions of application and the measurements will be repeated the day after the last session. A home exercise program will be created for the patients in both groups. Statistical analysis will be calculated using SPSS for Windows 22 program.

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Device: Electrophysical agents; Other: home exercise program; Device: vagus stimülation device

Detailed Description

Low back pain is one of the common problems that 80% of people experience at least once in their lifetime. Treatment of chronic low back pain includes surgical treatment, medical treatment and conservative treatment. The aim of conservative treatment is to raise the patient to the best possible level. Evidence levels for approaches commonly used in the clinic for the treatment of chronic low back pain were generally very low to moderate. It has been stated that the success of treatment is low in patients who are taken to conventional rehabilitation in the clinic, due to the lack of personal programs and the problems caused by the lack of human resources and space.

In recent studies, it has been shown that vagal nerve stimulation modulates peripheral and central nociceptive functions and reduces pain response. As a result, it was found that the pain threshold increased and the mechanical pain sensitivity decreased.

When we look at the literature; Although there are many studies on the treatment of chronic low back pain, there are no studies on the use of vagus nerve stimulation. Vagus nerve stimulation can be used as an adjunct therapy to correct autonomic nerve dysfunction.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul Avrupa Kitasi
    • Istanbul, Istanbul Avrupa Kitasi, Turkey, 34353
      • Gamze Demircioğlu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• be between the ages of 20-60
• volunteering to work
• Having low back pain for more than 3 months
• Diagnosis of chronic low back pain by the doctor
• Being able to read and write and be cooperative.
• Not having received treatment for the lumbar region in the last 3 months

Exclusion Criteria:

• Not having any lumbar surgery or vertebral fracture
• Being neurological, radiculopathy, inflammatory etc disease
• Having spinal deformities such as scoliosis or kyphosis
• Vestibular or respiratory disorder, Auditory or cognitive impairment
• Taking medication that will affect the balance (sedatives, etc.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: grup 1; Grup 1: Participants will be treated with ultrasound (5 min), TENS with a hot pack for (20 minutes). Home exercises will be given. The home exercises will be given consist of isometric waist, hip flexor stretching, hamstring stretching, self-mobilization exercise, waist and abdominal concentric strength exercises. 1.5w/cm² continuous ultrasound wiil applied with Chattanooga Intelect Mobile Ultrasound device.TENS: It will be applied to the lumbar region with a COMPEX brand stim device, together with a hot pack.The current intensity was opened by questioning according to the sensory threshold of the people. Home based exercise program:In the first week of the exercise program; isometric exercises, stretching and mobilization exercises were given. Second week; additional bridging exercise; In the third week, additional isotonic, active abdominal and back strengthening exercises were included in all exercises. The application will be done in 15 sessions, 5 days a week	Device: Electrophysical agents; Electrophysical agents (EPAs) are those modalities that administer thermal, mechanical, electrical or light energy to the patient to provide physiological effects and therapeutic benefits.; Other: home exercise program; The home exercise program will be explained to the patients by the physiotherapist and will also be given to the patient in the form of a brochure. Patients will be instructed to do the exercises regularly, three times a day for ten repetitions each day. The content of the exercises is updated weekly.
Experimental: grup 2; Grup 2: Participants will be given auricular vagus stimulation (25 min). Home exercises will be given. The home exercises will be given consist of isometric waist, hip flexor stretching, hamstring stretching, self-mobilization exercise, waist and abdominal concentric strength exercises. Vagus stimulation: A specially manufactured earphone that can be selected according to the size of the ear placed in the outer ear will be applied from the vagustim device (frequency 10 Hz, pulse duration less than 500 microseconds, in modulated TENS mode and biphasic asymmetric waveform) connected to it. Home based exercise program: In the first week of the exercise program; isometric exercises, stretching and mobilization exercises were given. Second week; additional bridging exercise; In the third week, additional isotonic, active abdominal and back strengthening exercises were included in all exercises. The application will be done in 15 sessions, 5 days a week.	Other: home exercise program; The home exercise program will be explained to the patients by the physiotherapist and will also be given to the patient in the form of a brochure. Patients will be instructed to do the exercises regularly, three times a day for ten repetitions each day. The content of the exercises is updated weekly.; Device: vagus stimülation device; Vagustim is a wearable medical technology device that focuses on non-invasive bilateral auricular vagus nerve stimulation (VNS). VNS is a clinically approved, safe and effective neuromodulation method.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oswestry Disability Index (ODİ)	The Oswestry Disability Index is the most commonly used outcome-measure questionnaire for low back pain in a hospital setting. Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage. Thus, for every question not answered, the denominator is reduced by 5. A score of 0-20 reflects minimal disability, 21-40 moderate disability, 41-60 severe disability, 61-80 crippled, and 81-100 bed-bound.	3 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lumbal Region Joint Range of Motion	we will use Inclinometer.	3 week
Modified Schober Test,	Schober's test is a physical examination used in family medicine, physical medicine and rehabilitation, rheumatology to measure the ability of a patient to flex the lower back.	3 week
trunk muscle strength (Lafayette manual muscle strength measuring device)	The Lafayette Manual Muscle Tester (MMT) is an ergonomic hand-held device for objectively quantifying muscle strength. Tests are performed with the clinician applying force to the limb of a patient. The objective is for the clinician to overcome or "break" the patient's resistance.	3 week
lower body muscle strength (CSMI-Cybex Humac-Norm isokinetic dynamometer)	A CYBEX Isokinetic Test is used to measure the maximum strength of a joint throughout its available range-of-motion (ROM).	3 week
trunk muscle endurance	Trunk muscle endurance of the subjects was evaluated using flexor endurance and Sorensen tests.	3 week
Balance assessment (BBS, Biodex Medical Systems),	Using this unique device, clinicians can assess neuromuscular control by quantifying the ability to maintain dynamic bilateral and unilateral postural stability on a static or unstable surface. Use any of four test protocols including fall risk, athletic single leg stability, limits of stability and postural stability.	3 week
Visual Analogue Scale (VAS)	The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain.	3 week
The Beck Depression Inventory (BDI)	The Beck Depression Inventory (BDI) is a 21-item self-reporting questionnaire for evaluating the severity of depression in normal and psychiatric populations. The Beck Depression Inventory (BDI) is a 21-item, multiple-choice inventory. Respondents are asked to rate each item based on four response choices according to the severity of the symptoms, ranging from the absence of a symptom to an intense level, during the past week. Individual scale items are scored on a 4-point continuum (0=least, 3=most), with a total summed score range of 0-63. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.	3 week
The Pittsburgh Sleep Quality Index (PSQI)	The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. Each of the sleep components yields a score ranging from 0 to 3, with 3 indicating the greatest dysfunction. The sleep component scores are summed to yield a total score ranging from 0 to 21 with the higher total score (referred to as global score) indicating worse sleep quality.	3 week

Collaborators and Investigators

• Sponsor: Istanbul Medipol University Hospital
• Investigators: Principal Investigator: gamze demircioğlu, phd(c), istanbul medipol hastanesi

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2022
• Primary Completion (Actual): February 8, 2023
• Study Completion (Actual): March 27, 2023

Study Registration Dates

• First Submitted: October 18, 2022
• First Submitted That Met QC Criteria: December 2, 2022
• First Posted (Actual): December 12, 2022

Study Record Updates

• Last Update Posted (Actual): April 11, 2023
• Last Update Submitted That Met QC Criteria: April 10, 2023
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: vagus nerve stimülation
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: Low Back Pain

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Study Data/Documents

1. data
   Information comments: Chakravarthy KV, Xing F, Bruno K, Kent AR, Raza A, Hurlemann R, Kinfe TM. A Review of Spinal and Peripheral Neuromodulation and Neuroinflammation: Lessons Learned Thus Far and Future Prospects of Biotype Development. Neuromodulation. 2019 Apr;22(3):235-243. doi: 10.1111/ner.12859. Epub 2018 Oct 12. PMID: 30311715.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No