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

Not Applicable

Not yet recruiting

• Conditions: Diastasis Recti; Diastasis Recti and Weakness of the Linea Alba; Diastasis; Diastasis Recti Abdominis
• Interventions: Other: Radiofrequency; Other: Control

• Registration Number: NCT06214650
• Lead Sponsor: University of Castilla-La Mancha

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-12-27
• Study First Submitted QC: 2024-01-10
• Study First Posted: 2024-01-19
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-08
• Study Start: 2024-09
• Primary Completion: 2026-12
• Study Completion: 2029-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 44

Inclusion Criteria

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

Exclusion Criteria

• 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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Radiofrequency group	Radiofrequency	All participants will be receive two interventions: 1. A weekly session for 10 weeks with radiofrequency. It will be use the protocol of INDIBA. Each session will last 30 minutes. 2. Participants will do an homely exercise protocol. This protocol will practise for 3 days at week.
Control group	Control	All participants will be receive two interventions: 1. A weekly session for 10 weeks with radiofrequency. It will be use INDIBA without intensity such as a placebo. Each session will last 30 minutes. 2. Participants will do an homely exercise protocol. This protocol will practise for 3 days at week.

Primary Outcome Measures

Name	Time	Method
Width of the diastasis recti abdominis	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.

Secondary Outcome Measures

Name	Time	Method
Participant's quality of life	At baseline pre intervention and inmediately after the intervention (10 weeks later)	Quality of life will be assessed using the Short form (36) questionnaire, which consist in thirty six questions about how pathology affects the participant's life.
Low back pain	At baseline pre intervention and inmediately after the intervention (10 weeks later)	It will analysed the low back pain in the participants using the visual analogic scale (VAS). The participants will choose a level of pain (0-5) in the scale.