Impact of Electromagnetic Field Therapy on Pain and Function in Patients With Mechanical Back Pain

Study Overview
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Brief Summary
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This study aims to investigate the impact of electromagnetic field therapy on pain severity and functional disability in mechanical back pain patients suffering from myofascial trigger points.

Detailed Description
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Lower back pain, or LBP, is a major global health issue that affects functioning, social participation, and personal financial prosperity on a variety of biophysical, psychological, and social levels. In today's industrial society, it impacts roughly 50-80% of people who are of working age. Mechanical back pain patients suffer from myofascial trigger points (MTrPs), which are classified as either active or latent. Activated MTrPs cause either sudden onset of pain or in response to movement, stretching, or compression. Latent MTrPs are typically symptom-free, but when squeezed, they can re-create pain or irritation. Muscle weakness and limited ROM are other common signs of mechanical back pain, along with local as well as referred pain that affect patients functional activities. Recently, there has been a focus on non-pharmacotherapy for low back pain. One of them is electromagnetic field therapy (PEMF) which uses electromagnetic field pulses to stimulate tissue healing without causing heat damage to the tissue. The FDA has given electromagnetic field therapy devices approval for treating post-operative pain, swelling, and osteoarthritis. Furthermore, PEMF devices are frequently used to treat bone fractures, inflammation, arthritis, pain, swelling, and chronic wounds. Thus, the purpose of this study is to ascertain how electromagnetic field therapy affects the degree of pain and functional impairment in mechanical back pain patients suffering from myofascial trigger points.

Official Title
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Impact of Electromagnetic Field Therapy on Pain Severity and Functional Disability in Patients With Mechanical Back Pain: a Randomized Controlled Trial

Conditions
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Mechanical Low Back Pain

Intervention / Treatment
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* Radiation: Pulsed electromagnetic field
* Other: traditional physical therapy program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patients age from 20 to 40 years for both genders. Patients (office worker) with mechanical back pain for 3 months ago and has not been diagnose as a specific disease or spinal abnormality. Patients suffering from active MTrPS in lower back muscles. The study patients must be willing to participate in the study. Exclusion Criteria: Neurological, systemic illness and infectious diseases such as rheumatologic diseases, tumor. Psychiatric/mental deficit. Patients who had a previous surgical history (within 6 months) were also excluded prior to the baseline assessment. Vertebral compression fracture Pregnancy and lactation. Existing lower limb symptoms. Cardiopulmonary disorders with reduced activity tolerance. -

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: pulsed electromagnetic fields therapy and traditional physical therapy program
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pulsed electromagnetic field<br>the patients will receive pulsed electromagnetic field plus traditional physical therapy program three times a week for four weeks | Radiation: Pulsed electromagnetic field<br>* The experimental group will be treated with an ASA magnetic field device (Automatic PMT Quattro Pro) at a frequency of 50 Hz in addition to the traditional physical therapy program. Each session will consist of 20 minutes of the patient lying prone and exposed to low-intensity 20-gauss PEMF.<br>Other: traditional physical therapy program<br>* A traditional physical therapy program will include Infrared radiation for 20 minutes per session for 3 sessions per week for 4 weeks Ultrasonic: 1 MHz; continuous mode of application: 1.5 w/cm2 for 5 minutes; 3 sessions per week for 4 weeks. stretching exercises for the hamstring, calf muscles, and back muscles. 3 sessions per week for 4 weeks Strengthening exercises for back and abdominal muscles.<br>|
| Active Comparator: traditional physical therapy program<br>the patients will receive traditional physical therapy program three times a week for four week | Other: traditional physical therapy program<br>* A traditional physical therapy program will include Infrared radiation for 20 minutes per session for 3 sessions per week for 4 weeks Ultrasonic: 1 MHz; continuous mode of application: 1.5 w/cm2 for 5 minutes; 3 sessions per week for 4 weeks. stretching exercises for the hamstring, calf muscles, and back muscles. 3 sessions per week for 4 weeks Strengthening exercises for back and abdominal muscles.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain intensity | A Visual Analogue Scale (VAS) will be used by the patient to mark his or her level of pain, usually 10 cm long, ranging from no pain or discomfort (zero) to the worst pain that the patient can possibly feel. | up to four weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| functional disability | Arabic version of Oswestry Disability Index will be used for assessment of functional disability | up to four weeks | 
| lumbar flexion and extension assessment | modified Schober test will be used to assess lumbar flexion and extension | up to four weeks | 
| lumbar lateral flexion assessment | tape measurement will be used to assess lumbar lateral flexion | up to four weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Electromagnetic Field, Mechanical back pain, Myofascial trigger point, Pain severity