NCT05646173

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Istanbul Medipol University Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-11-11
• Primary completion: 2023-02-08
• Completion: 2023-03-27
• First posted: 2022-12-12
• Last updated: 2023-04-11

Locations

1 site across 1 country: Turkey (Türkiye)