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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorUniversity of Castilla-La Mancha

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Women diagnosed with diastasis recti abdominis (DRA)

Age range18-45 years old

Women not DRA treated previously

Women not diagnosed with umbilical hernia

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Radiofrequency

    Other intervention

    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

    Other intervention

    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.

Treatment groups

44 Participants
are divided into 2 treatment groups
Group A: Radiofrequency groupExperimental treatment 1 intervention
Group B: Control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Width of the diastasis recti abdominis

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.

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

Secondary outcomes

1

Participant's quality of life

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.

Time frame
At baseline pre intervention and inmediately after the intervention (10 weeks later)
2

Low back pain

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.

Time frame
At baseline pre intervention and inmediately after the intervention (10 weeks later)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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