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

Not Applicable

Completed

• Conditions: Mechanical Low Back Pain
• Interventions: Radiation: Pulsed electromagnetic field; Other: traditional physical therapy program

• Registration Number: NCT06133855
• Lead Sponsor: Cairo University

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.

Study Timeline

• Study First Submitted: 2023-11-10
• Study First Submitted QC: 2023-11-14
• Study First Posted: 2023-11-18
• Study Start: 2023-12-01
• Primary Completion: 2024-02-29
• Study Completion: 2024-02-29
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-03
• Last Update Posted: 2024-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

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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. -

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
pain intensity	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 Outcome Measures

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

Trial Locations

Locations (1)

Ghada Mohamed Rashad Koura; 🇸🇦 Abha, Saudi Arabia