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

NCT05646173 | Completed

• 1 other identifier: low back pain
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Keywords

vagus nerve stimülation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Lumbal Region Joint Range of Motion

  3 week

• Modified Schober Test,

  3 week

• trunk muscle strength (Lafayette manual muscle strength measuring device)

  3 week

• lower body muscle strength (CSMI-Cybex Humac-Norm isokinetic dynamometer)

  3 week

• trunk muscle endurance

  3 week

Study Arms (2)

grup 1

ACTIVE COMPARATOR

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; Other: home exercise program

grup 2

EXPERIMENTAL

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.

Device: vagus stimülation device; Other: home exercise program

Interventions

vagus stimülation device 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.

grup 2

Electrophysical agents 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.

grup 1

home exercise program 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 1; grup 2

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (1)

Gamze Demircioglu

Istanbul, Istanbul Avrupa Kitasi, 34353, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• gamze demircioğlu, phd(c)

  istanbul medipol hastanesi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Double (Participant, Outcomes Assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 60 patients, aged between 18 and 60, with persistent low back pain who voluntarily agreed to participate in the study will be included in the study. Patient Identification Form, Lumbal Region Joint Range of Motion and Mobility (Inclinometer, Modified Schober Test), muscle strength (CSMI-Cybex Humac-Norm isokinetic dynamometer and 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), Oswestry Disability Index. Statistical analysis will be calculated using SPSS for Windows 22 program.

Study Record Dates

• First Submitted: October 18, 2022
• First Posted: December 12, 2022
• Study Start: November 11, 2022
• Primary Completion: February 8, 2023
• Study Completion: March 27, 2023
• Last Updated: April 11, 2023

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)