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

NCT05646173 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-04-11

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • Istanbul Medipol University Hospital

    lead OTHER

Principal Investigators

  • gamze demircioğlu, phd(c) · istanbul medipol hastanesi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-11
Primary Completion
2023-02-08
Completion
2023-03-27

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05646173 on ClinicalTrials.gov