Acute Effects of Radiofrequency Diathermy in Postpartum Women With Diastasis Abdominis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age20-45
SponsorUniversity of Valencia
About this trial
This clinical trial aims to compare the immediate tissue response in postpartum women with and without rectus abdominis diastasis (RAD) after undergoing radiofrequency diathermy (RFD) treatment. The main question it seeks to answer is: Do postpartum women with and without RAD exhibit different acute tissue responses in terms of pressure pain threshold, superficial thermal sensitivity, and tissue elasticity? To determine whether there are differences in these acute tissue responses between the groups, researchers will compare RFD with a sham RFD intervention in postpartum women with and without RAD.
Participants will receive one session of either RFD or a sham RFD intervention and will complete three assessments: one at baseline and two after the intervention, one immediately afterwards and one 20 minutes afterwards.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age between 20 and 45 years old.
BMI between 18.5 and 29.9 kg/mw.
Postpartum period between 6 months and 1 year Additionally, in the group of women with RAD, pathological RAD will be defined as an inter-rectus distance greater than 2.2 cm (measured 3 cm above the navel), according to the criteria of Beer et al. (2009)
Disqualifiers
Previous surgeries involving the abdominal wall.
Cesarean deliveries.
Women diagnosed with chronic pain
Trial design
Design model
Parallel
Treatments tested in this trial
Radiofrequency diathermy (RFD)
Other interventionRFD for 20 minutes, with 10 minutes applied using the capacitive method and 10 minutes using the resistive method.
Radiofrequency diathermy (RFD)
Other interventionRFD for 20 minutes, with 10 minutes applied using the capacitive method and 10 minutes using the resistive method
Sham radiofrequency diathermy ( sham RFD)
Other intervention20 minutes of application of the RFD device without energy emission. 10 minutes using the capacitative electrode, and 10 minutes using the resistive electrode.
Sham radiofrequency diathermy ( sham RFD)
Other intervention20 minutes of application of the RFD device without energy emission.10 minutes using the capacitative electrode, and 10 minutes using the resistive electrode.
Treatment groups
48 Participants
are divided into 4 treatment groupsGroup A: RFD women with RADExperimental treatment 1 intervention
Group B: RFD women without RADExperimental treatment 1 intervention
Group C: Sham RFD women with RADSham comparator 1 intervention
Group D: Sham RFD women without RADSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Pressure pain threshold
The pressure pain threshold will be measured using an algometer by applying progressive force to a supraumbilical point (three centimetres above the navel, at the lateral border of the rectus abdominis on the dominant side) until the participant reports pain. A higher value indicates a higher pain threshold.
Time frame
Baseline, immediately after the intervention and 20 minutes after the intervention.2
Superficial thermal sensitivity
Superficial thermal sensitivity will be assessed using the Thermal Visual Analogue Scale. For this, the capacitive electrode will be placed over the rectus abdominis on both sides for 30 seconds. Participants will then rate their thermal sensation on a scale from 0 (no heat) to 10 (maximum tolerable heat).
Time frame
Baseline, immediately after the interventino and 20 minutes after the intervention3
Tissue elasticity
The MyotonPRO® myometer will be used to measure tissue elasticity over the rectus abdominis on both sides. Higher values indicate greater stiffness and lower tissue elasticity.
Time frame
Baseline, immediately after the interventino and 20 minutes after the interventionSponsors and contacts
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Source ClinicalTrials.gov