Diastasis Recti Abdominis and a Combined Treatment With Abdominal Exercise and Radiofrequency

Официальное название

Efficacy of a Combined Treatment With Abdominal Exercise and Radiofrequency in Postpartum Women With Diastasis Recti Abdominis

Обзор

Diastasis recti abdominis is a pathology that appears in a high percentage of women during the postpartum period. However, there is little evidence about its treatment. The present protocol aims to evaluate the efficacy of radiofrequency as an alternative for the treatment of abdominal diastasis along with abdominal exercises compared to the only intervention through abdominal exercise. An aleatory clinical testing will be conducted where 44 women diagnosed with diastasis recti abdominis in the postpartum period will be recruited. A common exercise protocol will be applied for two groups of participants, and both of them will have to be able to carry out the activities autonomously at home. In addition, control sessions will be held weekly for both groups where one of the groups, the control group (n=22), will receive radiofrequency therapy with the machine in athermic mode, while the other group, the experimental group (n=22), will receive a weekly session under the established diathermy protocol. The sessions will last 30 minutes and will take place for 10 consecutive weeks. Three variables will be evaluated: the width of the diastasis measured in centimeters, life quality measured using the Short form (36) questionnaire, and the perception of the pain measured with the visual analogue scale. Three evaluations will be done: at the beginning of the study, after ten weeks and three months later.

Вмешательства

• Другое Radiofrequency
  Experimental group will receive the common exercise program associated with a radiofrequency treatment using INDIBA® (INDIBA Activ 7, Barcelona, INDIBA S.A.) at a frequency of 448 hertz. It will use the capacitive electrode as a method of preparation and vascularization of the superficial tissues and immediately, within the same session, the resistive electrode to stimulate deep tissues. This treatment is based on the protocols established by INDIBA® S.A. It will consist of one weekly diathermy
• Другое Control
  Control group will receive a weekly INDIBA® session in the abdominal area with the same protocol as the experimental group in athermic mode (placebo treatment) and the common exercise program. The session will last thirty minutes and will be carried out by the research physiotherapist during ten weeks.

Первичные конечные точки

• Width of the diastasis recti abdominis [Срок оценки: It will be collected two measures to compare the changes: at baseline to the study and ten weeks later.]

Вторичные конечные точки (2)

• Participant's quality of life [Срок оценки: At baseline pre intervention and inmediately after the intervention (10 weeks later)]
• Low back pain [Срок оценки: At baseline pre intervention and inmediately after the intervention (10 weeks later)]

Критерии участия

Критерии включения

• Women diagnosed with diastasis recti abdominis (DRA)
• Age range18-45 years old
• Women not DRA treated previously
• Women not diagnosed with umbilical hernia

Критерии исключения

• DRA width less than 2.5cm
• Women diagnosed with intestinal disease such as irritable bowel syndrome (IBS) or Chron disease.
• Women looking for a new pregnancy or pregnant women.
• Women who can not receive diathermy treatment (e.g tumoral process, open wound in the abdominal area or any diathermy contraindication).

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: NCT06214650 · Lpena1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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