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

NCT ID: NCT05646173

Last Updated: 2023-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-11
• Study Completion Date: 2023-03-27

Brief Summary

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.

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.

Conditions

Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Electrophysical agents

Intervention Type: DEVICE

Electrophysical agents (EPAs) are those modalities that administer thermal, mechanical, electrical or light energy to the patient to provide physiological effects and therapeutic benefits.

home exercise program

Intervention Type: OTHER

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.

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.

Group Type: EXPERIMENTAL

vagus stimülation device

Intervention Type: 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.

home exercise program

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Eligibility Criteria

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.)

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul Medipol University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

gamze demircioğlu, phd(c)

Role: PRINCIPAL_INVESTIGATOR

istanbul medipol hastanesi

Locations

Gamze Demircioglu

Istanbul, Istanbul Avrupa Kitasi, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Study Documents

Document Type: data

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.

View Document

Other Identifiers

low back pain

Identifier Type: -

Identifier Source: org_study_id