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临床试验/NCT05731479
NCT05731479已完成不适用

Effectiveness of a Radiofrequency Diathermy and Therapeutic Exercise Protocol in Women With Abdominal Diastasis. Randomized Controlled Trial

University of Valencia1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2023年1月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
34
试验地点
1
主要终点
Rectus abdominis distance

研究概览

简要总结

Diastasis recti abdominis (DRA) is defined as the presence of divergence between the rectus abdominis muscles along the linea alba. DRA is associated with decreased abdominal strength and degraded health and physical functioning, which results in poorer body perception and satisfaction and negatively affects the quality of life in its multiple spheres (social, sexual and personal). Regarding the different treatment techniques for DRA, different treatments have been described, such as bandages, electrotherapy or therapeutic exercise, the latter being the most scientifically supported option to approach DRA conservatively. Exercise has shown positive effects on DRA severity, abdominal muscle thickness, abdominal strength and endurance, and quality of life in women with DRA.

Another treatment that has shown promising effects in various pathologies is radiofrequency diathermy using the Capacitive-Resistive Electrical Transfer system. The capacitive mode acts on soft tissues containing electrolytes such as muscles and vascular and lymphatic tissues. On the other hand, the resistive mode acts on tissues of higher density and fat and fiber content, such as bones, ligaments and tendons. It has been documented that this type of therapy acts favoring the vascularization of tissues, decreasing inflammation and favoring the processes of cellular repair and analgesia. Its beneficial effect on low back pain and various pelvic floor disorders has been studied. However, at present, there are no studies evaluating the effectiveness of this type of intervention in people with abdominal diastasis.

In view of the above, the objective of our study is to evaluate the effectiveness of a protocol based on therapeutic exercise preceded by a radiofrequency diathermy program on anthropometric parameters, anatomo-physiological parameters, functional parameters, and parameters related to psychological aspects in women with postpartum abdominal diastasis.

详细描述

A longitudinal randomized controlled experimental study will be carried out. The sample will be composed of 34 postpartum women, randomly distributed in two groups: i) diathermy + exercise group (GDE) (n=17), and ii) placebo diathermy + exercise group (GPE) (n=17).

The evaluations will be performed at two time points: i) before the intervention (T1), and ii) after the last session (T2).

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
Single (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
否

入选标准

  • •Women aged 18 to 45 years,
  • •3 to 24 months postpartum
  • •Criteria of abdominal diastasis according to Beer's criteria (Beer et al.2009)

排除标准

  • •Rejection to sign the informed consent form
  • •Presence of any metabolic, neurological or connective tissue disease, as well as cognitive alterations.

研究组 & 干预措施

Diathermy + exercise group

Experimental

Application of diathermy and a therapeutic exercise protocol.

干预措施: Diathermy + exercise group (Other)

Diathermy placebo + exercise group

Placebo Comparator

Application of the diathermy device without energy emission and a therapeutic exercise protocol.

干预措施: Diathermy placebo + exercise group (Other)

结局指标

主要结局

Rectus abdominis distance

时间窗: Immediately after the intervention

The distance between rectus abdominis in millimetres (mm) will be assessed with an ultrasound machine, using a high-resolution linear array transducer.

Rectus abdominis thickness

时间窗: Immediately after the intervention

The rectus abdominis thickness in millimetres (mm) will be assessed with an ultrasound machine, using a high-resolution linear array transducer.

Rectus abdominis distance

时间窗: Baseline

The distance between rectus abdominis in millimetres (mm) will be assessed with an ultrasound machine, using a high-resolution linear array transducer.

Rectus abdominis thickness

时间窗: Baseline

The rectus abdominis thickness in millimetres (mm) will be assessed with an ultrasound machine, using a high-resolution linear array transducer.

次要结局

  • Perception of change after the intervention(Immediately after the intervention)
  • Strength of the abdominal flexor musculature(Immediately after the intervention)
  • Linea alba thickness(Immediately after the intervention)
  • Body composition(Immediately after the intervention)
  • Kinesiophobia(Immediately after the intervention)
  • Body image(Immediately after the intervention)
  • Linea alba distortion index(Immediately after the intervention)
  • Stabilization capacity and resistance of the abdomino-lumbo-pelvic capsule(Immediately after the intervention)
  • Abdominal circumference(Immediately after the intervention)
  • Abdominal fold(Immediately after the intervention)
  • Body composition(Baseline)
  • Strength of the abdominal flexor musculature(Baseline)
  • Kinesiophobia(Baseline)
  • Body image(Baseline)
  • Perception of change after the intervention(Baseline)
  • Linea alba thickness(Baseline)
  • Linea alba distortion index(Baseline)
  • Stabilization capacity and resistance of the abdomino-lumbo-pelvic capsule(Baseline)
  • Abdominal circumference(Baseline)
  • Abdominal fold(Baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marta Inglés de la Torre

Associate Professor of Physiotherapy

University of Valencia

研究点 (1)

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