NCT07419399

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
34mo left

Started Mar 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress7%
Mar 2026Mar 2029

First Submitted

Initial submission to the registry

February 11, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 19, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

March 30, 2026

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2029

Last Updated

February 19, 2026

Status Verified

February 1, 2026

Enrollment Period

3 years

First QC Date

February 11, 2026

Last Update Submit

February 11, 2026

Conditions

PostpartumRectus Muscle Diastasis

Keywords

rectus abdominis diastasisradiofrequency diathermypostpartum

Outcome Measures

Primary Outcomes (3)

  • 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.

    Baseline, immediately after the intervention and 20 minutes after the intervention.

  • 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).

    Baseline, immediately after the interventino and 20 minutes after the intervention

  • 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.

    Baseline, immediately after the interventino and 20 minutes after the intervention

Study Arms (4)

RFD women with RAD

EXPERIMENTAL

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 women without RAD

EXPERIMENTAL

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)

Sham RFD women with RAD

SHAM COMPARATOR

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)

Sham RFD women without RAD

SHAM COMPARATOR

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)

Interventions

Radiofrequency diathermy (RFD)OTHER

RFD for 20 minutes, with 10 minutes applied using the capacitive method and 10 minutes using the resistive method.

Also known as: Radiofrequency, Diathermy
RFD women with RAD
Sham radiofrequency diathermy ( sham RFD)OTHER

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 RFD women with RAD

Eligibility Criteria

Age20 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physiotherapy. University of Valencia

Valencia, Valencia, 46022, Spain

RECRUITING

Related Publications (3)

  • 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: 19637295BACKGROUND

  • 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: 31580698RESULT

  • 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: 40740146RESULT

MeSH Terms

Interventions

Diathermy

Intervention Hierarchy (Ancestors)

Hyperthermia, InducedTherapeutics

Central Study Contacts

Marta Inglés de la Torre, PHD

CONTACT

686320380marta.ingles@uv.es

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

February 11, 2026

First Posted

February 19, 2026

Study Start

March 30, 2026

Primary Completion (Estimated)

March 30, 2029

Study Completion (Estimated)

March 30, 2029

Last Updated

February 19, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)