Clinical trial NCT06214650: Diastasis Recti Abdominis and a Combined Treatment With Abdominal Exercise and Radiofrequency
Official title: Efficacy of a Combined Treatment With Abdominal Exercise and Radiofrequency in Postpartum Women With Diastasis Recti Abdominis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Diastasis
Diastasis Recti
Diastasis Recti and Weakness of the Linea Alba
Diastasis Recti Abdominis
Lead sponsor: University of Castilla-La Mancha
Sponsor class: OTHER
First posted: 2024-01-19
Enrollment: 44
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: Width of the diastasis recti abdominis
timeFrame: It will be collected two measures to compare the changes: at baseline to the study and ten weeks later.
Secondary outcomes:
measure: Participant's quality of life
timeFrame: At baseline pre intervention and inmediately after the intervention (10 weeks later)
measure: Low back pain
timeFrame: At baseline pre intervention and inmediately after the intervention (10 weeks later)
Other outcomes:
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