Comparison of Two Electrotherapy Methods on Chronic Low Back Pain

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is; to compare the effects of interferential current therapy (IF) applied in addition to conventional physical therapy on pain, functional status and quality of life compared to pulsed electromagnetic field therapy (PEMF) in patients with chronic low back pain.

Detailed Description
-----------------
The low back is the most common region for musculoskeletal pain. Many factors play a role in the etiology of low back pain. A certain etiological factor or pathophysiological mechanism cannot be found in 85-90% of the patients. Approximately 80% of those living in industrialized countries experience low back pain in some part of their lives. 10% of low back pain becomes chronic. It is believed that 1% of workforce losses are due to low back pain. This type of pain often occurs when the back muscles, tendons and ligaments are exposed to stress or strain. Mechanical back pains are chronic pain that often affects the lower part of the spine and radiates to the gluteal region. Since daily activities such as leaning, turning, lifting, standing and sitting for a long time increase the pain, the intensity of the pain increases during the day. Interferential current (IF) therapy is obtained from two medium frequency currents and is applied by delivering a low frequency current (for example 20 to 100 Hz) to the tissue. Pulsed ElectroMagnetic Field (PEMF) therapy, which is among physical therapy methods, is frequently used in the treatment of knee, hip and spine osteoarthritis symptoms. It is thought that magnetic field therapy improves the oxygen utilization of the cells and the erythrocytes release more oxygen under the influence of the magnetic field, thus having a positive effect on the circulatory system

Official Title
-----------------
Comparison of Effectiveness of Pulsed Electromagnetic Field Therapy and Interferential Current on Patients With Chronic Low Back Pain

Conditions
-----------------
Low Back Pain, Mechanical

Intervention / Treatment
-----------------
* Other: Pulse Electromagnetic Field
* Other: Interferential Current
* Other: Sham


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Being diagnosed with nonspecific low back pain Symptom onset with more than 3 months Exclusion Criteria: History of surgery on low back region Structural deformity on the low back region Radiculopathy Tumor or malignancy Any skin condition that prevents usage of electrotherapy Having a pace maker or other types of implants on the low back, pelvis and thoracic region

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Three groups with a conventional therapy control group.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pulse Electromagnetic Field Group<br>Pulse Electromagnetic Field Therapy (PEMF) will be applied to patients' low back region. Also, patients will receive a conventional therapy program consisting of hotpack, ultrasound, and transcutaneous electrical stimulation in addition to PEMF therapy. | Other: Pulse Electromagnetic Field<br>* Patients will be treated for two weeks, five days a week, one session a day, and 10 sessions with PEMF in prone position. Each session will be 45 minute long with a 15 minute PEMF therapy and a 30 minute conventional therapy program.<br>|
| Active Comparator: Interferential Current Group<br>Interferential current will be applied to patients' low back pain region. Also, patients will receive a conventional therapy program consisting of hotpack, ultrasound, and transcutaneous electrical stimulation in addition to Interferential current. | Other: Interferential Current<br>* Patients will be treated for two weeks, five days a week, one session a day, and 10 sessions with Interferential current in prone position. Four interferential electrode will be placed on low back region. Each session will be 45 minute long with a 15 minute interferential current and a 30 minute conventional therapy program.<br>|
| Sham Comparator: Sham Group<br>Sham electrodes will be placed on the low back region. Also, patients will receive a conventional therapy program consisting of hotpack, ultrasound, and transcutaneous electrical stimulation in addition to sham therapy. | Other: Sham<br>* Patients will be treated for two weeks, five days a week, one session a day, and 10 sessions with conventional therapy and sham electrotherapy. Sham application will be performed on prone position with four electrodes and electrodes will stay for 15 minutes on this region.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Numerical Rating Scale (NRS) | It contains 11 digits that should be assigned according to the perceived pain intensity on a numerical scale. The participant chooses the number that best reflects his or her pain. In our study, the patients were informed that the '0' point was not pain at all, and the '10' point expressed unbearable pain. | two weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Roland-Morris Disability Questionnaire | It is a questionnaire developed to evaluate functional disabilities in patients with low back pain. Turkish validity and reliability study was conducted in 2001 (20). In the 24-sentence questionnaire about functional impairments, patients are asked to answer each sentence as yes if it fits their situation, and no if it does not. Yes responses are calculated as 1 and no answers are calculated as 0 points. In this questionnaire with a total score between 0-24, the higher score means more disability. | two weeks | 
| Euroqol Quality Of Life Scale | EQ-5D is a self-report scale developed by the EuroQoL group, the Western European quality of life research community, and evaluates five dimensions with 1 question each. These five dimensions consist of subtitles of mobility, self-care, usual daily activities, pain / discomfort and anxiety / depression. The answers given to each dimension have 3 options: no problem, some problem and major problem. As a result, 243 possible different health outcomes are defined with the scale. An index score ranging from -0.59 to 1 is calculated from the 5 dimensions of the scale. In the score function, a value of 0 indicates death, a value of 1 indicates perfect health, while negative values indicate unconsciousness, living dependent on bed, etc. show situations. Also included in the scale is a VAS (EQ-VAS) that includes answers between 0 and 100, ie 0 = the worst health condition imaginable and 100 = the best health condition imaginable. | two weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rehabilitation, Electric Stimulation Therapy, Quality of Life, Pain