Comparison of the Efficacy of Auricular Vagus Nerve Stimulation and Electrotherapy Modalities in Chronic Low Back Pain
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Low Back Pain
- Sponsor
- Istanbul Medipol University Hospital
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Oswestry Disability Index (ODİ)
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
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.)
Outcomes
Primary Outcomes
Oswestry Disability Index (ODİ)
Time Frame: 3 week
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.
Secondary Outcomes
- Modified Schober Test,(3 week)
- Lumbal Region Joint Range of Motion(3 week)
- Visual Analogue Scale (VAS)(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)
- Balance assessment (BBS, Biodex Medical Systems),(3 week)
- The Beck Depression Inventory (BDI)(3 week)
- The Pittsburgh Sleep Quality Index (PSQI)(3 week)