Effectiveness of PEMF in Patients With Chronic Radicular Pain Due to Lomber Disc Herniation

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to investigate the effectiveness of pulse magnetic field therapy on pain, functional status, and quality of life in patients with chronic radicular pain due to lumbar disc herniation.

Detailed Description
-----------------
Pulsed Electromagnetic Field Therapy (PEMF) is a non-invasive, painless treatment for various injuries, bone related conditions and pains. However, further studies on PEMF effects on low back and radicular pain is needed due to lack of studies in this area.

Official Title
-----------------
Effectiveness of Pulse Electromagnetic Field Therapy (PEMF) on Pain, Functional Status, and Quality of Life in Patients With Chronic Radicular Pain Due to Lumbar Disc Herniation

Conditions
-----------------
Lumbar Disc Herniation

Intervention / Treatment
-----------------
* Device: PEMF
* Device: Hot pack
* Device: TENS
* Device: Sham PEMF


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-65 Unilateral radicular pain for at least 3 months Severity of radicular pain with Visual Analog Score of at least 4/10 Written informed consent Exclusion Criteria: Pregnancy or lactation Cardiac pacemaker, or any metal implants or electronic devices anywhere in the body History of surgery or algological procedure of the lumbar region Physical therapy within the last year due to back pain Previous PEMF treatment Malignancy or suspicion Polyneuropathy (diabetic or other) Connective tissue disease Presence of inflammatory joint pain Fibromyalgia Presence of open surface wound Tuberculosis, mycosis, or viral disease Presence of pain in another region of the body with higher severity than radicular back pain Use of drugs other than paracetamol-derivative simple analgesics (Nonsteroidal Aanti inflammatuar, central effective, or narcotic analgesics), or less than three weeks since the discontinuation of these drugs Advanced mood disorder Radiographic evidence of Grade 2 spondylolisthesis, presence of spinal instability, and advanced degenerative spondylarthrosis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pulsed electromagnetic field (PEMF) treatment Group<br>Group received routine hot pack, Transcutaneous electrical nerve stimulation (TENS) and PEMF treatment. | Device: PEMF<br> <br> Device: Hot pack<br> <br> Device: TENS<br> <br> |
| Sham Comparator: Sham PEMF treatment Group<br>Group received routine hot pack, TENS and sham PEMF treatment. | Device: Hot pack<br> <br> Device: TENS<br> <br> Device: Sham PEMF<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 10 cm Pain Visual Analogue Scale (VAS) | The patient is asked to indicate their perceived pain intensity along a 10cm horizontal line, where '0' represents 'no pain' and '10', 'unbearable pain'. | 3 weeks | 
| 10 cm Pain Visual Analogue Scale (VAS) | The patient is asked to indicate their perceived pain intensity along a 10 cm horizontal line, where '0' represents 'no pain' and '10', 'unbearable pain'. | one month after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disability; Roland-Morris Disability Questionnaire (RMDQ) | RMDQ has 24 yes/no questions. Scoring is between 0-24. A score of 0: no disability, score of >1 indicates disability. | 3 weeks | 
| Disability; Roland-Morris Disability Questionnaire (RMDQ) | RMDQ has 24 yes/no questions. Scoring is between 0-24. A score of 0: no disability, score of >1 indicates disability. | One month after treatment | 
| Nottingham Health Profile (NHP) | Nottingham Health Profile (NHP) is a questionnaire designed to measure a patient's view of their own health status, in a number of areas. The NHP consists of two parts. The first part focuses on health and comprises 38 items which deal with pain, energy, sleep, mobility, emotional reaction and social isolation. All questions have only yes/no answer options and each section score is weighted. The higher the score, the greater the number and severity of problems. The highest score in any section is 100. | 3 weeks | 
| Nottingham Health Profile (NHP) | Nottingham Health Profile (NHP) is a questionnaire designed to measure a patient's view of their own health status, in a number of areas. The NHP consists of two parts. The first part focuses on health and comprises 38 items which deal with pain, energy, sleep, mobility, emotional reaction and social isolation.All questions have only yes/no answer options and each section score is weighted. The higher the score, the greater the number and severity of problems. The highest score in any section is 100. | One month after treatment |