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

NCT07278596 | Not Yet Recruiting

• 1 other identifier: Electromagnetic Therapy
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Back Pain Lower Back; Magnetic Therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Quality of life assessment

  Baseline and after 8 weeks

Study Arms (2)

High intensity focused electromagnetic therapy group

ACTIVE COMPARATOR

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); Other: Stabilization exercise program

Control group

ACTIVE COMPARATOR

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

Interventions

High intensity focused electromagnetic therapy (HIFEMT) 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.

High intensity focused electromagnetic therapy group

Stabilization exercise program 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; High intensity focused electromagnetic therapy group

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Middle East University: lead

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Mohamed Sayed Saif

  National institute for Gerontology

  STUDY DIRECTOR

Central Study Contacts

Saher Elgayar, Ph.D

CONTACT

+201020429911; saherlotfy020@gmail.com

Mohammed Elhamrawy, Ph.D

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Physical Therapy

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: December 12, 2025
• Study Start: December 7, 2025
• Primary Completion: March 30, 2026
• Study Completion: April 1, 2026
• Last Updated: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share