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

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

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.

Study Overview

• Status: Completed
• Conditions: Mechanical Low Back Pain
• Intervention / Treatment: Radiation: Pulsed electromagnetic field; Other: traditional physical therapy program

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Abha, Saudi Arabia
    • Ghada Mohamed Rashad Koura

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. The patients age from 20 to 40 years for both genders.
2. Patients (office worker) with mechanical back pain for 3 months ago and has not been diagnose as a specific disease or spinal abnormality.
3. Patients suffering from active MTrPS in lower back muscles.
4. The study patients must be willing to participate in the study.

Exclusion Criteria:

1. Neurological, systemic illness and infectious diseases such as rheumatologic diseases, tumor.
2. Psychiatric/mental deficit.
3. Patients who had a previous surgical history (within 6 months) were also excluded prior to the baseline assessment.
4. Vertebral compression fracture
5. Pregnancy and lactation.
6. Existing lower limb symptoms.
7. Cardiopulmonary disorders with reduced activity tolerance. -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pulsed electromagnetic field; the patients will receive pulsed electromagnetic field plus traditional physical therapy program three times a week for four weeks	Radiation: Pulsed electromagnetic field; 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.; Other: traditional physical therapy program; 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.
Active Comparator: traditional physical therapy program; the patients will receive traditional physical therapy program three times a week for four week	Other: traditional physical therapy program; 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.

What is the study measuring?

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
lumbar lateral flexion assessment	tape measurement will be used to assess lumbar lateral flexion	up to four weeks
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-modified Schober test will be used to assess lumbar flexion and extension	up to four weeks

Collaborators and Investigators

• Sponsor: Cairo University
• Collaborators: King Khalid University
• Investigators: Study Director: Ghada MR Koura, Ass. prof, King Khalid University, Saudi Arabia

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2023
• Primary Completion (Actual): February 29, 2024
• Study Completion (Actual): February 29, 2024

Study Registration Dates

• First Submitted: November 10, 2023
• First Submitted That Met QC Criteria: November 14, 2023
• First Posted (Actual): November 18, 2023

Study Record Updates

• Last Update Posted (Estimated): March 5, 2024
• Last Update Submitted That Met QC Criteria: March 3, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Myofascial trigger point; Mechanical back pain; Electromagnetic Field; Pain severity
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: HAPO-06-B-001; ECM#2023-2104

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No