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

NCT ID: NCT07278596

Last Updated: 2025-12-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-07
• Study Completion Date: 2026-04-01

Brief Summary

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

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.

Conditions

Back Pain Lower Back; Magnetic Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

High intensity focused electromagnetic therapy (HIFEMT)

Intervention Type: OTHER

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.

Stabilization exercise program

Intervention Type: OTHER

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.

Control group

Stabilization Exercise Program:

Both the study and control groups will receive lumbar stabilization exercise program three times weekly for 8 weeks.

Group Type: ACTIVE_COMPARATOR

Stabilization exercise program

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Middle East University

OTHER

Sponsor Role: lead

Responsible Party

Saher Lotfy El Gayar

Assistant Professor of Physical Therapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohamed Sayed Saif

Role: STUDY_DIRECTOR

National institute for Gerontology

Central Contacts

Saher Elgayar, Ph.D

Role: CONTACT

saherlotfy020@gmail.com

+201020429911

Mohammed Elhamrawy, Ph.D

Role: CONTACT

Other Identifiers

Electromagnetic Therapy

Identifier Type: -

Identifier Source: org_study_id