Acute Effects of Radiofrequency Diathermy in Postpartum Women With Diastasis Abdominis (RDPP)

February 11, 2026 updated by: Marta Inglés de la Torre, University of Valencia

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
    • Valencia
      • Valencia, Valencia, Spain, 46022
        • Recruiting
        • Faculty of Physiotherapy. University of Valencia
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • Previous surgeries involving the abdominal wall.
  • Cesarean deliveries.
  • Women diagnosed with chronic pain

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RFD women with RAD
Women with RAD will receive RFD for 20 minutes, with 10 minutes applied using the capacitive method and 10 minutes using the resistive method.
Other: Radiofrequency diathermy (RFD)
RFD for 20 minutes, with 10 minutes applied using the capacitive method and 10 minutes using the resistive method.
Other Names:
  • Diathermy
  • Radiofrequency
Other: Radiofrequency diathermy (RFD)
RFD for 20 minutes, with 10 minutes applied using the capacitive method and 10 minutes using the resistive method
Other Names:
  • Diathermy
  • Radiofrequency
Experimental: RFD women without RAD
Women without RAD will also receive RFD for 20 minutes, with 10 minutes applied using the capacitive method and 10 minutes using the resistive method
Other: Radiofrequency diathermy (RFD)
RFD for 20 minutes, with 10 minutes applied using the capacitive method and 10 minutes using the resistive method.
Other Names:
  • Diathermy
  • Radiofrequency
Other: Radiofrequency diathermy (RFD)
RFD for 20 minutes, with 10 minutes applied using the capacitive method and 10 minutes using the resistive method
Other Names:
  • Diathermy
  • Radiofrequency
Sham Comparator: Sham RFD women with RAD
Women with RAD will receive 20 minutes of application of the RFD device without energy emission. 10 minutes using the capacitive electrode and 10 minutes using the resistive electrode.
Other: Sham radiofrequency diathermy ( sham RFD)
20 minutes of application of the RFD device without energy emission. 10 minutes using the capacitative electrode, and 10 minutes using the resistive electrode.
Other: Sham radiofrequency diathermy ( sham RFD)
20 minutes of application of the RFD device without energy emission.10 minutes using the capacitative electrode, and 10 minutes using the resistive electrode.
Sham Comparator: Sham RFD women without RAD
Women without RAD will likewise receive 20 minutes of application of the RFD device without energy emission. 10 minutes using the capacitive electrode and 10 minutes using the resistive electrode.
Other: Sham radiofrequency diathermy ( sham RFD)
20 minutes of application of the RFD device without energy emission. 10 minutes using the capacitative electrode, and 10 minutes using the resistive electrode.
Other: Sham radiofrequency diathermy ( sham RFD)
20 minutes of application of the RFD device without energy emission.10 minutes using the capacitative electrode, and 10 minutes using the resistive electrode.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pressure pain threshold
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.
Baseline, immediately after the intervention and 20 minutes after the intervention.
Superficial thermal sensitivity
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).
Baseline, immediately after the interventino and 20 minutes after the intervention
Tissue elasticity
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.
Baseline, immediately after the interventino and 20 minutes after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Valencia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 30, 2026

Primary Completion (Estimated)

March 30, 2029

Study Completion (Estimated)

March 30, 2029

Study Registration Dates

First Submitted

February 11, 2026

First Submitted That Met QC Criteria

February 11, 2026

First Posted (Actual)

February 19, 2026

Study Record Updates

Last Update Posted (Actual)

February 19, 2026

Last Update Submitted That Met QC Criteria

February 11, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-FIS-4249101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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