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

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Другое 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
• Другое 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.

Первичные конечные точки

• Back pain [Срок оценки: Baseline and after 8 weeks]

Вторичные конечные точки (1)

• Quality of life assessment [Срок оценки: Baseline and after 8 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07278596 · Electromagnetic Therapy

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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