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Recruiting NCT07419399

Acute Effects of Radiofrequency Diathermy in Postpartum Women With Diastasis Abdominis

No phase Interventional Postpartum Rectus Muscle Diastasis

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 diathermy (RFD), Radiofrequency diathermy (RFD), Sham radiofrequency diathermy ( sham RFD), Sham radiofrequency diathermy ( sham RFD).
Who it may be relevant to
Registry conditions: Postpartum, Rectus Muscle Diastasis. Basic parameters: 20 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
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

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.

Interventions

  • Other Radiofrequency diathermy (RFD)
    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 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.

Primary outcome measures

  • Pressure pain threshold [Time frame: 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]
  • Tissue elasticity [Time frame: Baseline, immediately after the interventino and 20 minutes after the intervention]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Spain · 1 center
  • Faculty of Physiotherapy. University of Valencia — Valencia

Publications

  • Beer GM, Schuster A, Seifert B, Manestar M, Mihic-Probst D, Weber SA. The normal width of the linea alba in nulliparous women. Clin Anat. 2009 Sep;22(6):706-11. doi: 10.1002/ca.20836. PMID 19637295
  • Clijsen R, Leoni D, Schneebeli A, Cescon C, Soldini E, Li L, Barbero M. Does the Application of Tecar Therapy Affect Temperature and Perfusion of Skin and Muscle Microcirculation? A Pilot Feasibility Study on Healthy Subjects. J Altern Complement Med. 2020 Feb;26(2):147-153. doi: 10.1089/acm.2019.0165. Epub 2019 Oct 3. PMID 31580698
  • Fuentes-Aparicio L, Munoz-Gomez E, Molla-Casanova S, Moreno-Segura N, Ingles M. Impact of capacitive resistive monopolar radiofrequency prior to a therapeutic physical exercise program on morphology and functionality in women with rectus diastasis: a randomized controlled trial. Disabil Rehabil. 2026 Jan;48(2):470-481. doi: 10.1080/09638288.2025.2540068. Epub 2025 Jul 31. PMID 40740146

Identifiers

NCT: NCT07419399 · 2025-FIS-4249101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗