Diastasis Recti Abdominis and a Combined Treatment With Abdominal Exercise and Radiofrequency
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Radiofrequency, Control.
- Who it may be relevant to
- Registry conditions: Diastasis, Diastasis Recti, Diastasis Recti and Weakness of the Linea Alba, Diastasis Recti Abdominis. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy of a Combined Treatment With Abdominal Exercise and Radiofrequency in Postpartum Women With Diastasis Recti Abdominis
Overview
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.
Interventions
- Other 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 - 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.
Primary outcome measures
- Width of the diastasis recti abdominis [Time frame: It will be collected two measures to compare the changes: at baseline to the study and ten weeks later.]
Secondary outcome measures (2)
- Participant's quality of life [Time frame: At baseline pre intervention and inmediately after the intervention (10 weeks later)]
- Low back pain [Time frame: At baseline pre intervention and inmediately after the intervention (10 weeks 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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06214650 · Lpena1