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Идёт набор NCT07419399

Acute Effects of Radiofrequency Diathermy in Postpartum Women With Diastasis Abdominis

Без фазы С лечением Postpartum Rectus Muscle Diastasis

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: Radiofrequency diathermy (RFD), Radiofrequency diathermy (RFD), Sham radiofrequency diathermy ( sham RFD), Sham radiofrequency diathermy ( sham RFD).
Кому может быть актуально
Состояния в реестре: Postpartum, Rectus Muscle Diastasis. Базовые параметры: 20 лет — 45 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Испания
Следующий шаг
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Обзор

This clinical trial aims to compare the immediate tissue response in postpartum women with and without rectus abdominis diastasis (RAD) after undergoing radiofrequency diathermy (RFD) treatment. The main question it seeks to answer is: Do postpartum women with and without RAD exhibit different acute tissue responses in terms of pressure pain threshold, superficial thermal sensitivity, and tissue elasticity? To determine whether there are differences in these acute tissue responses between the groups, researchers will compare RFD with a sham RFD intervention in postpartum women with and without RAD. Participants will receive one session of either RFD or a sham RFD intervention and will complete three assessments: one at baseline and two after the intervention, one immediately afterwards and one 20 minutes afterwards.

Подробное описание

A randomised controlled experimental study will be conducted. The sample will consist of 48 postpartum women: 24 who have been diagnosed with pathological RAD and 24 who have not. The participants will be randomly assigned to one of two groups: (i) a radiofrequency diathermy (RFD) group (n = 12), and (ii) a sham RFD group (n = 12). All participants will receive a single treatment session. Evaluations will be performed at three time points: baseline, immediately after the intervention and 20 minutes post-intervention. The variables assessed will include pressure pain threshold, superficial thermal sensitivity and tissue elasticity.

Вмешательства

  • Другое Radiofrequency diathermy (RFD)
    RFD for 20 minutes, with 10 minutes applied using the capacitive method and 10 minutes using the resistive method.
  • Другое Radiofrequency diathermy (RFD)
    RFD for 20 minutes, with 10 minutes applied using the capacitive method and 10 minutes using the resistive method
  • Другое Sham radiofrequency diathermy ( sham RFD)
    20 minutes of application of the RFD device without energy emission. 10 minutes using the capacitative electrode, and 10 minutes using the resistive electrode.
  • Другое Sham radiofrequency diathermy ( sham RFD)
    20 minutes of application of the RFD device without energy emission.10 minutes using the capacitative electrode, and 10 minutes using the resistive electrode.

Первичные конечные точки

  • Pressure pain threshold [Срок оценки: Baseline, immediately after the intervention and 20 minutes after the intervention.]
  • Superficial thermal sensitivity [Срок оценки: Baseline, immediately after the interventino and 20 minutes after the intervention]
  • Tissue elasticity [Срок оценки: Baseline, immediately after the interventino and 20 minutes after the intervention]

Критерии участия

Критерии включения

  • Age between 20 and 45 years old.
  • BMI between 18.5 and 29.9 kg/mw.
  • Postpartum period between 6 months and 1 year Additionally, in the group of women with RAD, pathological RAD will be defined as an inter-rectus distance greater than 2.2 cm (measured 3 cm above the navel), according to the criteria of Beer et al. (2009)

Критерии исключения

  • Previous surgeries involving the abdominal wall.
  • Cesarean deliveries.
  • Women diagnosed with chronic pain

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

Испания · 1 центр
  • Faculty of Physiotherapy. University of Valencia — Valencia

Публикации

  • Beer GM, Schuster A, Seifert B, Manestar M, Mihic-Probst D, Weber SA. The normal width of the linea alba in nulliparous women. Clin Anat. 2009 Sep;22(6):706-11. doi: 10.1002/ca.20836. PMID 19637295
  • Clijsen R, Leoni D, Schneebeli A, Cescon C, Soldini E, Li L, Barbero M. Does the Application of Tecar Therapy Affect Temperature and Perfusion of Skin and Muscle Microcirculation? A Pilot Feasibility Study on Healthy Subjects. J Altern Complement Med. 2020 Feb;26(2):147-153. doi: 10.1089/acm.2019.0165. Epub 2019 Oct 3. PMID 31580698
  • Fuentes-Aparicio L, Munoz-Gomez E, Molla-Casanova S, Moreno-Segura N, Ingles M. Impact of capacitive resistive monopolar radiofrequency prior to a therapeutic physical exercise program on morphology and functionality in women with rectus diastasis: a randomized controlled trial. Disabil Rehabil. 2026 Jan;48(2):470-481. doi: 10.1080/09638288.2025.2540068. Epub 2025 Jul 31. PMID 40740146

Идентификаторы

NCT: NCT07419399 · 2025-FIS-4249101

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗