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

NCT ID: NCT06133855

Last Updated: 2024-03-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2024-02-29

Brief Summary

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

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.

Conditions

Mechanical Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Pulsed electromagnetic field

the patients will receive pulsed electromagnetic field plus traditional physical therapy program three times a week for four weeks

Group Type: EXPERIMENTAL

Pulsed electromagnetic field

Intervention Type: RADIATION

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.

traditional physical therapy program

Intervention Type: OTHER

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.

traditional physical therapy program

the patients will receive traditional physical therapy program three times a week for four week

Group Type: ACTIVE_COMPARATOR

traditional physical therapy program

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: RADIATION

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.

Intervention Type: OTHER

Eligibility Criteria

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. -

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

King Khalid University

OTHER

Sponsor Role: collaborator

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Doaa Ayoub Elimy Mohammed

Lecturer of physical therapy for basic science department., faculty of physical Therapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ghada MR Koura, Ass. prof

Role: STUDY_DIRECTOR

King Khalid University, Saudi Arabia

Locations

Ghada Mohamed Rashad Koura

Abhā, , Saudi Arabia

Countries

Saudi Arabia

Other Identifiers

HAPO-06-B-001; ECM#2023-2104

Identifier Type: -

Identifier Source: org_study_id