Faculty of Physiotherapy. University of Valencia
Valencia, 46022, Spain
Location status: Recruiting
Location contact
CONTACT
NCT Number: NCT07419399
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.
Interested in participating?
Request Info20 year–45 year
Female
Interventional
Not applicable
Valencia, 46022, Spain
Location status: Recruiting
CONTACT
A randomised controlled experimental study will be conducted. The sample will consist of 48 postpartum women: 24 who have been diagnosed with pathological RAD and 24 who have not. The participants will be randomly assigned to one of two groups: (i) a radiofrequency diathermy (RFD) group (n = 12), and (ii) a sham RFD group (n = 12). All participants will receive a single treatment session. Evaluations will be performed at three time points: baseline, immediately after the intervention and 20 minutes post-intervention. The variables assessed will include pressure pain threshold, superficial thermal sensitivity and tissue elasticity.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
RFD for 20 minutes, with 10 minutes applied using the capacitive method and 10 minutes using the resistive method.
Other names: Radiofrequency, Diathermy
20 minutes of application of the RFD device without energy emission. 10 minutes using the capacitative electrode, and 10 minutes using the resistive electrode.
Time frame: Baseline, immediately after the intervention and 20 minutes after the intervention.
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 interventino and 20 minutes after the intervention
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 intervention
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.
Contact information is provided by the study sponsor or research team.
University of Valencia
Other
Acronym: RDPP
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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