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

NCT06133855 | Completed

• 1 other identifier: HAPO-06-B-001; ECM#2023-2104
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Mechanical Low Back Pain

Keywords

Electromagnetic Field; Mechanical back pain; Myofascial trigger point; Pain severity

Outcome Measures

Primary Outcomes (1)

• pain intensity

  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.

  up to four weeks

Secondary Outcomes (3)

• functional disability

  up to four weeks

• lumbar flexion and extension assessment

  up to four weeks

• lumbar lateral flexion assessment

  up to four weeks

Study Arms (2)

Pulsed electromagnetic field

EXPERIMENTAL

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

Radiation: Pulsed electromagnetic field; Other: traditional physical therapy program

traditional physical therapy program

ACTIVE COMPARATOR

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

Other: traditional physical therapy program

Interventions

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.

Pulsed electromagnetic field

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.

Pulsed electromagnetic field; traditional physical therapy program

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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. -

Sponsors & Collaborators

• Cairo University: lead
• King Khalid University: collaborator

Study Sites (1)

Ghada Mohamed Rashad Koura

Abhā, Saudi Arabia

Location

MeSH Terms

Conditions

Low Back Pain; Pain

Condition Hierarchy (Ancestors)

Back Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ghada MR Koura, Ass. prof

  King Khalid University, Saudi Arabia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: random generator
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of physical therapy for basic science department., faculty of physical Therapy

Model Details: pulsed electromagnetic fields therapy and traditional physical therapy program

Study Record Dates

• First Submitted: November 10, 2023
• First Posted: November 18, 2023
• Study Start: December 1, 2023
• Primary Completion: February 29, 2024
• Study Completion: February 29, 2024
• Last Updated: March 5, 2024

Record last verified: 2024-03

Locations

SA (1)