Effect of Pulsed Electromagnetic Field on Pruritus in Burn Scars

Обзор

This study will be conducted to evaluate the effectiveness of pulsed electromagnetic field therapy in pruritus in patients with burn scars.

Подробное описание

Burn injuries are among the most devastating and complex forms of trauma, often requiring prolonged medical care and rehabilitation. These injuries can cause substantial damage to the skin and underlying tissues, leading to acute complications such as infection, fluid loss, and metabolic dysregulation. However, the long-term consequences of burn injuries extend beyond the initial trauma, significantly affecting survivors' physical and psychological well-being .The pathophysiology of burn scar pruritus is complex and multifactorial, involving a combination of nerve regeneration, inflammation, and abnormal scar tissue remodeling. During the healing process, damaged nerve fibers regenerate in an unorganized manner, leading to hyperexcitability and an increased sensation of itch. This aberrant nerve regrowth is thought to be a key driver of neuropathic itch in burn scars. Evidence suggests that PEMF therapy may influence nerve signaling pathways involved in neuropathic and inflammatory itch. By addressing both neural and inflammatory components, PEMF therapy offers a novel mechanism of action that could be particularly beneficial for burn survivors. However, its efficacy in the context of burn scar pruritus has not been rigorously evaluated, highlighting the need for clinical research .

Вмешательства

• Другое pulsed electromagnetic field therapy
  The pulsed electromagnetic field applicator will be positioned 2 cm above the affected burn scar area, ensuring full coverage of the scar with Frequency: 27.12 MHz, Pulse duration: 65 microseconds, and Intensity: 20 Gauss. the patients will receive also standard care
• Другое standard care
  the patients will receive standard care in the form of Application of topical emollients (e.g., silicone-based creams) twice daily to maintain hydration, Moisturizing skin care routines to prevent dryness and irritation, and Gentle scar massage for 10 minutes daily to improve scar pliability.

Первичные конечные точки

• pain intensity [Срок оценки: up to 6 weeks]
• life disability [Срок оценки: up to 6 weeks]

Критерии участия

Критерии включения

• Patients aged 25-40 years.
• Patients with second and third-degree burn scars sustained at least 3 months prior to enrollment.
• Patients experiencing a pruritus score ≥ 5 on the Visual Analog Scale (VAS).
• Patients who have not undergone prior PEMF therapy or other physical therapy interventions for pruritus in the past 3 months.

Критерии исключения

• Patients with cardiac pacemakers, implanted defibrillators, or other electronic medical devices.
• Pregnant or lactating women.
• Patients with uncontrolled systemic diseases (e.g., diabetes, hypertension) or active skin infections.
• Patients with psychological disorders that would interfere with their ability to adhere to the treatment protocol.
• Patients with allergic reaction to food or drugs

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

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07443358 · P.T.REC/012/005747

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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