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Набор скоро начнётся NCT07443371

Effect of Transfer Energy Capacitive and Resistive Therapy on Palmar Fibromatosis

Без фазы С лечением Palmar Fibromatosis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Transfer Energy Capacitive and Resistive (TECAR) therapy, Traditional therapy.
Кому может быть актуально
Состояния в реестре: Palmar Fibromatosis. Базовые параметры: 40 лет — 70 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Египет
Следующий шаг
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Обзор

The objective of the present study is to explore the effect of Transfer Energy Capacitive and Resistive Therapy (TECAR) therapy on pain, range of motion (ROM) and hand function in dupuytren's contracture patients (palmar fibromatosis).

Подробное описание

Dupuytren contracture is a benign, progressive disease of the palmar fascia which results in shortening, thickening, and fibrosis of the fascia and aponeurosis of the palm driven by myofibroblastic proliferation.

TECAR therapy is considered a special form of energy that uses frequencies between 300 KHz and 1 MHz and is characterized as a non-invasive high-frequency energy that awakens the body's natural ability to self-regenerate.

The TECAR therapy can work in two modes of electric charge transfer: capacitive and resistive mode. The reactions produced by the capacitive system through the capacitive electrode are focused on tissues with higher electrolyte content, such as soft tissues and muscles, as opposed to the resistive system that focuses on larger and more resistant tissues such as tendons, bones and articulations. With these two modes of energy transfer, the therapy allows an increase in vasodilation, oxygenation, increase in microcirculation and increase in internal temperature. So, this study aimed to to explore the effect of Transfer Energy Capacitive and Resistive Therapy (TECAR) therapy on pain, range of motion (ROM) and hand function in dupuytren's contracture patients (palmar fibromatosis).

Вмешательства

  • Устройство Transfer Energy Capacitive and Resistive (TECAR) therapy
    The apparatus used is comprised of a generator that supplies a signal at the frequency of 0.5 MHz and a maximum power of 300 watts (HCR900).The power can be regulated by controlling the quantity of transferred energy and the relative biological action. The counter electrode (Return Plate) that closes the circuit consists of a metal plate that is applied in opposition or a cylinder that is clasped. The head of the device will be applied over the treated area for 20 minutes (min) (10 min of capac
  • Другое Traditional therapy
    The patients will receive the traditional physical therapy program 3 sessions / week , for 6 weeks totally. It consists of stretching exercise, flexor tendon glide and splinting.

Первичные конечные точки

  • Active range of motion (ROM) assessment of metacarpophalangeal joint (MCP): [Срок оценки: 6 weeks]
  • Active range of motion (ROM) assessment of proximal interphalangeal joint (PIP): [Срок оценки: 6 weeks]
  • Pain intensity measurement [Срок оценки: 6 weeks]
Вторичные конечные точки (1)
  • The Southampton Dupuytren's Scoring Scale [Срок оценки: 6 weeks]

Критерии участия

Критерии включения

  • Ages of patients will be ranged from 40 to 70 years.
  • Presence of palpable cords and/or digital contracture ≥ 20° at the metacarpophalengeal joint or Proximal interphalengeal joint joints .
  • Clinical diagnosis confirmed by a hand surgeon or relevant specialist.
  • All patients will enter the study having their informed consent

Критерии исключения

  • Patient with severe contracture >30° or multiple digit involvement requiring surger.
  • History of surgical release (fasciotomy, fasciectomy) or collagenase injection in the affected hand.
  • Presence of infection, ulceration, or skin lesions on the treatment area.
  • Presence of pacemakers, metal implants, or other electronic implants in the treatment area.
  • Active cancer or tumor in the treatment region.
  • Pregnancy.
  • Conditions such as stroke, Parkinson's disease, or rheumatoid arthritis that may confound results.
  • Cognitive impairment, psychiatric illness, or other barriers to protocol adherence

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

Египет · 1 центр
  • Peter Milad Haroun — Cairo

Идентификаторы

NCT: NCT07443371 · P.T.REC/012/006253

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗