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NCT Number: NCT06133855

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

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.

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Key information

Conditions

Mechanical Low Back Pain Back Pain Low Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ghada Mohamed Rashad Koura

Abhā, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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. -

Treatment and study plan

Pulsed electromagnetic field

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

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.

Primary outcomes

  1. pain intensity

    Time frame: up to four weeks

    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.

Secondary outcomes

  1. functional disability

    Time frame: up to four weeks

    Arabic version of Oswestry Disability Index will be used for assessment of functional disability

  2. lumbar flexion and extension assessment

    Time frame: up to four weeks

    modified-modified Schober test will be used to assess lumbar flexion and extension

  3. lumbar lateral flexion assessment

    Time frame: up to four weeks

    tape measurement will be used to assess lumbar lateral flexion

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Collaborators

  • King Khalid University

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 18, 2023
Registry last updated
Mar 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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