PostpartumRDPPNCT07419399
Acute Effects of Radiofrequency Diathermy in Postpartum Women With Diastasis Abdominis
A study testing Radiofrequency diathermy (RFD) in people with Postpartum and Rectus Muscle Diastasis, run by University of Valencia at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum, Rectus Muscle Diastasis
- What is being tested?
- Radiofrequency diathermy (RFD)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteSpain
- Study dates
- 30 Mar 2026to 30 Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- Previous surgeries involving the abdominal wall.
- Cesarean deliveries.
- Women diagnosed with chronic pain
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Faculty of Physiotherapy. University of Valencia
Valencia, Valencia, 46022
marta.ingles@uv.es
About this study
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.
Read the 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.
- Conditions
- Postpartum, Rectus Muscle Diastasis
- Being tested
- Radiofrequency diathermy (RFD), Sham radiofrequency diathermy ( sham RFD)
- Keywords
- rectus abdominis diastasis, radiofrequency diathermy, postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency diathermy (RFD)Other
Also called Radiofrequency, Diathermy
RFD for 20 minutes, with 10 minutes applied using the capacitive method and 10 minutes using the resistive method.
Radiofrequency diathermy (RFD)Other
Also called Radiofrequency, Diathermy
RFD for 20 minutes, with 10 minutes applied using the capacitive method and 10 minutes using the resistive method
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 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: 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. Receives: 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. Receives: Other: Sham radiofrequency diathermy ( sham RFD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: Baseline, immediately after the interventino and 20 minutes after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start30 Mar 2026
- Primary completion30 Mar 2029 (estimated)
- Study completion30 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PostpartumStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marta Inglés de la Torre, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07419399
- Sponsor's protocol ID
- 2025-FIS-4249101
- Acronym
- RDPP
- Status last verified
- Jun 2026
- First submitted
- 11 Feb 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 19637295Clijsen 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.
PubMed 31580698Fuentes-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.
PubMed 40740146
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Radiofrequency Diathermy in Postpartum Women With Diastasis Abdominis
- ClinicalTrials.gov ID
- NCT07419399
- Acronym / sponsor ID
- RDPP / 2025-FIS-4249101
- Conditions
- Postpartum, Rectus Muscle Diastasis
- Keywords
- rectus abdominis diastasis, radiofrequency diathermy, postpartum
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 30 Mar 2026 (actual)
- Primary completion
- 30 Mar 2029 (estimated)
- Study completion
- 30 Mar 2029 (estimated)
- First posted
- 19 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| RFD women with RAD | Experimental | Other: Radiofrequency diathermy (RFD)Women with RAD will receive RFD for 20 minutes, with 10 minutes applied using the capacitive method and 10 minutes using the resistive method. |
| RFD women without RAD | Experimental | Other: Radiofrequency diathermy (RFD)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 |
| Sham RFD women with RAD | Sham comparator | Other: Sham radiofrequency diathermy ( sham RFD)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. |
| Sham RFD women without RAD | Sham comparator | Other: Sham radiofrequency diathermy ( sham RFD)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. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- Previous surgeries involving the abdominal wall.
- Cesarean deliveries.
- Women diagnosed with chronic pain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiofrequency diathermy (RFD)Also: Radiofrequency, DiathermyRFD for 20 minutes, with 10 minutes applied using the capacitive method and 10 minutes using the resistive method. | Other | RFD women with RAD |
| Radiofrequency diathermy (RFD)Also: Radiofrequency, DiathermyRFD for 20 minutes, with 10 minutes applied using the capacitive method and 10 minutes using the resistive method | Other | RFD women without RAD |
| 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 RFD women with RAD |
| 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 RFD women without RAD |
Primary outcome
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.
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).
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Background: PubMed 19637295Beer 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.
- Results publication: PubMed 31580698Clijsen 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.
- Results publication: PubMed 40740146Fuentes-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency diathermy (RFD) in people with Postpartum and Rectus Muscle Diastasis, run by University of Valencia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marta Inglés de la Torre, PHD (686320380, marta.ingles@uv.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pressure pain threshold (time frame: Baseline, immediately after the intervention and 20 minutes after the intervention.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07419399, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.