High Intensity Focused Electromagnetic Therapy on Pain and Quality of Life in Patients With Lumbar Disc Prolapse

Effect of High Intensity Focused Electromagnetic Therapy on Pain and Quality of Life in Patients With Lumbar Disc Prolapse: a Randomized Controlled Trial

Determine whether high intensity focused electromagnetic therapy has a significant effect on pain and quality of life in patients with lumbar disc prolapse.

Study Overview

• Status: Not yet recruiting
• Conditions: Back Pain Lower Back; Magnetic Therapy
• Intervention / Treatment: Other: High intensity focused electromagnetic therapy (HIFEMT); Other: Stabilization exercise program

Detailed Description

Lumbar disc prolapse is a common cause of lower back pain and radiculopathy, frequently affecting individuals in their productive years. It results from displacement of the intervertebral disc material beyond the disc space, leading to nerve root compression and significant pain, disability, and decreased quality of life. Persistent pain and reduced physical function can impair daily activities and may lead to psychological distress. Traditional conservative management, such as physical therapy and pharmacological interventions, may not always provide sufficient relief. High intensity focused electromagnetic therapy is a non-invasive modality that uses electromagnetic fields to stimulate deep muscle contractions. It has shown potential in enhancing muscle strength, modulating pain, and improving functional outcomes in musculoskeletal conditions. However, its role in managing lumbar disc prolapse has not been thoroughly investigated.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Saher Elgayar, Ph.D; Phone Number: +201020429911; Email: saherlotfy020@gmail.com
• Study Contact Backup: Name: Mohammed Elhamrawy, Ph.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• A confirmed diagnosis of lumbar disc prolapse by clinical and radiological evaluation.
• Ages between 30 and 60 years.
• A history of low back pain for at least three months.
• A body mass index less than 30 kg/m².

Exclusion Criteria:

• History of spinal surgery or recent traumatic spinal injury.
• Severe spinal canal stenosis or progressive neurological deficits.
• Known malignancy, infection, or inflammatory arthritis affecting the spine.
• Presence of implanted metal devices or pacemakers contraindicating electromagnetic therapy.
• Pregnancy or suspected pregnancy.
• Cognitive or psychological disorders that impair communication or ability to follow instructions

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: High intensity focused electromagnetic therapy group; Participants in the study group will receive HIFEMT sessions using the HIFEMT device (Emsculpt Neo, BTL Industries, Boston, MA) twice weekly for 8 weeks.	Other: High intensity focused electromagnetic therapy (HIFEMT); The patient will be positioned in a comfortable supine or seated position depending on the targeted lumbar area. The applicator will be placed over the lumbar spine, delivering focused electromagnetic pulses to stimulate deep core and paraspinal muscles. Each session will last 30 minutes, conducted three times per week over a period of 8 weeks. The intensity will be progressively adjusted according to patient tolerance, aiming to induce visible supramaximal muscle contractions without discomfort. HIFEMT is intended to promote muscle strengthening, pain modulation, and spinal stabilization.; Other: Stabilization exercise program; Participants will be guided through core-strengthening exercises aimed at improving trunk stability, posture, and neuromuscular control. The exercises will include pelvic tilts, bridging, and bird-dog exercises. All sessions will be conducted under supervision of a physiotherapist. Each session will last for approximately 30 minutes, three times weekly for 8 weeks.
Active Comparator: Control group; Stabilization Exercise Program: Both the study and control groups will receive lumbar stabilization exercise program three times weekly for 8 weeks.	Other: Stabilization exercise program; Participants will be guided through core-strengthening exercises aimed at improving trunk stability, posture, and neuromuscular control. The exercises will include pelvic tilts, bridging, and bird-dog exercises. All sessions will be conducted under supervision of a physiotherapist. Each session will last for approximately 30 minutes, three times weekly for 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Back pain	Using the Arabic Numerical Pain Rating Scale (NPRS) to evaluate the intensity of pain at baseline and post-intervention	Baseline and after 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life assessment	Using the Short Form 12 Health Survey (SF-12) to evaluate both physical and mental health components of quality of life	Baseline and after 8 weeks

Collaborators and Investigators

• Sponsor: Middle East University
• Investigators: Study Director: Mohamed Sayed Saif, National institute for Gerontology

Study record dates

Study Major Dates

• Study Start (Estimated): December 7, 2025
• Primary Completion (Estimated): March 30, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: December 1, 2025
• First Submitted That Met QC Criteria: December 1, 2025
• First Posted (Actual): December 12, 2025

Study Record Updates

• Last Update Posted (Actual): December 12, 2025
• Last Update Submitted That Met QC Criteria: December 1, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Low Back Pain
• Other Study ID Numbers: Electromagnetic Therapy

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No