An interventional study of Radiofrequency and Control in Diastasis, Diastasis Recti and Diastasis Recti and Weakness of the Linea Alba, sponsored by University of Castilla-La Mancha. Not yet recruiting. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2024-05-08.
Sponsored by University of Castilla-La Mancha · Not applicable, Interventional, and Treatment
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.
41 studies on the registry are indexed under Diastasis, Muscle; 9 are open to participants now.
This study's planned enrollment of 44 is close to the median of 48 across 31 interventional studies indexed under Diastasis, Muscle.
Browse Diastasis, Muscle studies →University of Castilla-La Mancha is the lead sponsor of 104 studies on the registry; 24 are open to participants now.
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Exclusion Criteria:
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.
Other: Radiofrequency
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.
Other: Control
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 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.
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.
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)
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)
No study locations are listed for this record.
This study is not yet recruiting, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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University of Castilla-La Mancha