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

NCT ID: NCT06214650

Last Updated: 2024-05-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-30
• Study Completion Date: 2029-12-31

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.

Conditions

Diastasis; Diastasis Recti; Diastasis Recti and Weakness of the Linea Alba; Diastasis Recti Abdominis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Radiofrequency group

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.

Group Type: EXPERIMENTAL

Radiofrequency

Intervention Type: OTHER

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 session of thirty minutes during ten weeks. The use of diathermy will not be interrupted throughout the session.

The common exercise program consist in a ten abdominal exercises (including recti abdominis, transversus and obliques). It will practised at home only just three days at week.

Control group

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.

Group Type: ACTIVE_COMPARATOR

Control

Intervention Type: OTHER

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.

Interventions

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 session of thirty minutes during ten weeks. The use of diathermy will not be interrupted throughout the session.

The common exercise program consist in a ten abdominal exercises (including recti abdominis, transversus and obliques). It will practised at home only just three days at week.

Intervention Type: OTHER

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.

Intervention Type: OTHER

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Castilla-La Mancha

OTHER

Sponsor Role: lead

Responsible Party

LOURDES PEÑA ROMERO

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

Lpena1

Identifier Type: -

Identifier Source: org_study_id