Clinical trial NCT06133855: Impact of Electromagnetic Field Therapy on Pain and Function in Patients With Mechanical Back Pain
Official title: Impact of Electromagnetic Field Therapy on Pain Severity and Functional Disability in Patients With Mechanical Back Pain: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mechanical Low Back Pain
Keywords: Electromagnetic Field
Mechanical back pain
Myofascial trigger point
Pain severity
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: King Khalid University
First posted: 2023-11-18
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: pulsed electromagnetic fields therapy and traditional physical therapy program
Primary purpose: TREATMENT

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.

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. -

Primary outcomes:
measure: pain intensity
timeFrame: up to four weeks
Secondary outcomes:
measure: functional disability
timeFrame: up to four weeks
measure: lumbar flexion and extension assessment
timeFrame: up to four weeks
measure: lumbar lateral flexion assessment
timeFrame: up to four weeks
Other outcomes:
Locations:
city: Abha
country: Saudi Arabia
facility: Ghada Mohamed Rashad Koura
Study officials:
affiliation: King Khalid University, Saudi Arabia
name: Ghada MR Koura, Ass. prof
role: STUDY_DIRECTOR
References: