跳至主要内容
临床试验/NCT06214650
NCT06214650尚未招募不适用

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

University of Castilla-La Mancha0 个研究点目标入组 44 人开始时间: 2024年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
44
主要终点
Width of the diastasis recti abdominis

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

  • 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).

结局指标

主要结局

Width of the diastasis recti abdominis

时间窗: It will be collected two measures to compare the changes: at baseline to the study and ten weeks later.

The inter-recti diastasis will be measured with a transabdominal ultrasound using a lineal transductor. It will be assessed three measures: 2cm and 5cm above the umbilicus and 2cm below the umbilicus.

次要结局

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

研究者

发起方
University of Castilla-La Mancha
申办方类型
Other
责任方
Principal Investigator
主要研究者

LOURDES PEÑA ROMERO

Principal Investigator

University of Castilla-La Mancha

相似试验