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

Sponsor
Cairo University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06133855
Collaborator
King Khalid University (Other)
30
1
2
3
9.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Radiation: Pulsed electromagnetic field
  • Other: traditional physical therapy program
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
pulsed electromagnetic fields therapy and traditional physical therapy programpulsed electromagnetic fields therapy and traditional physical therapy program
Masking:
Double (Investigator, Outcomes Assessor)
Masking Description:
random generator
Primary Purpose:
Treatment
Official Title:
Impact of Electromagnetic Field Therapy on Pain Severity and Functional Disability in Patients With Mechanical Back Pain: a Randomized Controlled Trial
Anticipated Study Start Date :
Nov 1, 2023
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Feb 1, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. functional disability [up to four weeks]

    Oswestry Disability Index will be used for assessment of functional disability

  2. lumbar flexion and extension assessment [up to four weeks]

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

  3. lumbar lateral flexion assessment [up to four weeks]

    tape measurement will be used to assess lumbar lateral flexion

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 20 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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. -

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ghada Mohamed Rashad Koura Abha Saudi Arabia

Sponsors and Collaborators

  • Cairo University
  • King Khalid University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Doaa Ayoub Elimy Mohammed, Lecturer of physical therapy for basic science department., faculty of physical Therapy, Cairo University
ClinicalTrials.gov Identifier:
NCT06133855
Other Study ID Numbers:
  • HAPO-06-B-001; ECM#2023-2104
First Posted:
Nov 18, 2023
Last Update Posted:
Nov 18, 2023
Last Verified:
Nov 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Doaa Ayoub Elimy Mohammed, Lecturer of physical therapy for basic science department., faculty of physical Therapy, Cairo University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 18, 2023