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NCT Number: NCT07278596

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

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

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Key information

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Back pain

    Time frame: Baseline and after 8 weeks

    Using the Arabic Numerical Pain Rating Scale (NPRS) to evaluate the intensity of pain at baseline and post-intervention

Secondary outcomes

  1. Quality of life assessment

    Time frame: Baseline and after 8 weeks

    Using the Short Form 12 Health Survey (SF-12) to evaluate both physical and mental health components of quality of life

Study contacts

Contact information is provided by the study sponsor or research team.

Mohammed Elhamrawy, Ph.D

CONTACT

Saher Elgayar, Ph.D

CONTACT

[email protected]

+201020429911

Sponsors and collaborators

Lead sponsor

Middle East University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 12, 2025
Registry last updated
Dec 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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