Clinical trial NCT05646173: Efficacy of Auricular Vagus Nerve Stimulation and Electrotherapy Modalities in Patients With Chronic Low Back Pain
Official title: Comparison of the Efficacy of Auricular Vagus Nerve Stimulation and Electrotherapy Modalities in Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: vagus nerve stimülation
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2022-12-12
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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.)

Primary outcomes:
measure: Oswestry Disability Index (ODİ)
timeFrame: 3 week
Secondary outcomes:
measure: Lumbal Region Joint Range of Motion
timeFrame: 3 week
measure: Modified Schober Test,
timeFrame: 3 week
measure: trunk muscle strength (Lafayette manual muscle strength measuring device)
timeFrame: 3 week
measure: lower body muscle strength (CSMI-Cybex Humac-Norm isokinetic dynamometer)
timeFrame: 3 week
measure: trunk muscle endurance
timeFrame: 3 week
measure: Balance assessment (BBS, Biodex Medical Systems),
timeFrame: 3 week
measure: Visual Analogue Scale (VAS)
timeFrame: 3 week
measure: The Beck Depression Inventory (BDI)
timeFrame: 3 week
measure: The Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 3 week
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Gamze Demircioglu
state: Istanbul Avrupa Kitasi
Study officials:
affiliation: istanbul medipol hastanesi
name: gamze demircioğlu, phd(c)
role: PRINCIPAL_INVESTIGATOR
References: