Abdominal DiastasisNCT05731479
Radiofrequency Diathermy and Therapeutic Exercise Protocol in Women With Abdominal Diastasis
A study testing Diathermy + exercise group in people with Abdominal Diastasis, run by University of Valencia at 1 site in Spain.
Trial summary
Diastasis recti abdominis (DRA) is defined as the presence of divergence between the rectus abdominis muscles along the linea alba. DRA is associated with decreased abdominal strength and degraded health and physical functioning, which results in poorer body perception and satisfaction and negatively affects the… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Abdominal Diastasis
- What is being tested?
- Diathermy + exercise group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteSpain
- Study dates
- 16 Jan 2023to 30 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged 18 to 45 years,
- 3 to 24 months postpartum
- Criteria of abdominal diastasis according to Beer's criteria (Beer et al.2009)
Who cannot join
- Rejection to sign the informed consent form
- Presence of any metabolic, neurological or connective tissue disease, as well as cognitive alterations.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Faculty of Physiotherapy. University of Valencia
Valencia, Valencia, 46002
About this study
Official title: Effectiveness of a Radiofrequency Diathermy and Therapeutic Exercise Protocol in Women With Abdominal Diastasis. Randomized Controlled Trial
Diastasis recti abdominis (DRA) is defined as the presence of divergence between the rectus abdominis muscles along the linea alba. DRA is associated with decreased abdominal strength and degraded health and physical functioning, which results in poorer body perception and satisfaction and negatively affects the quality of life in its multiple spheres (social, sexual and personal). Regarding the different treatment techniques for DRA, different treatments have been described, such as bandages, electrotherapy or therapeutic exercise, the latter being the most scientifically supported option to approach DRA conservatively. Exercise has shown positive effects on DRA severity, abdominal muscle thickness, abdominal strength and endurance, and quality of life in women with DRA.
Another treatment that has shown promising effects in various pathologies is radiofrequency diathermy using the Capacitive-Resistive Electrical Transfer system. The capacitive mode acts on soft tissues containing electrolytes such as muscles and vascular and lymphatic tissues. On the other hand, the resistive mode acts on tissues of higher density and fat and fiber content, such as bones, ligaments and tendons. It has been documented that this type of therapy acts favoring the vascularization of tissues, decreasing inflammation and favoring the processes of cellular repair and analgesia. Its beneficial effect on low back pain and various pelvic floor disorders has been studied. However, at present, there are no studies evaluating the effectiveness of this type of intervention in people with abdominal diastasis.
In view of the above, the objective of our study is to evaluate the effectiveness of a protocol based on therapeutic exercise preceded by a radiofrequency diathermy program on anthropometric parameters, anatomo-physiological parameters, functional parameters, and parameters related to psychological aspects in women with postpartum abdominal diastasis.
Read the detailed description
A longitudinal randomized controlled experimental study will be carried out. The sample will be composed of 34 postpartum women, randomly distributed in two groups: i) diathermy + exercise group (GDE) (n=17), and ii) placebo diathermy + exercise group (GPE) (n=17).
The evaluations will be performed at two time points: i) before the intervention (T1), and ii) after the last session (T2).
- Conditions
- Abdominal Diastasis
- Being tested
- Diathermy + exercise group, Diathermy placebo + exercise group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diathermy + exercise groupOther
The Diathermy + Exercise group will receive diathermy for 15 minutes, of which 5 minutes will be applied in the capacitive method and 10 minutes in the resistive method. You will then perform 20 minutes of the following exercises: 1) Bird-Dog, 2) Crunch, 3) Obliques, 4) Drawing, 5) Half plank and 6) Side-plank. You will perform 8-12 repetitions and 3 sets of each exercise. 3 sessions of 35 minutes per week for 8 weeks.
Diathermy placebo + exercise groupOther
The Placebo + Exercise group will receive 15 minutes of application of the diathermy device without energy emission. It will then perform the same therapeutic exercise protocol described in the GDE. 3 sessions of 35 minutes per week for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Diathermy + exercise group | Experimental | Application of diathermy and a therapeutic exercise protocol. Receives: Other: Diathermy + exercise group |
| Diathermy placebo + exercise group | Placebo comparator | Application of the diathermy device without energy emission and a therapeutic exercise protocol. Receives: Other: Diathermy placebo + exercise group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rectus abdominis distance
The distance between rectus abdominis in millimetres (mm) will be assessed with an ultrasound machine, using a high-resolution linear array transducer.
Measured: Baseline
Rectus abdominis distance
The distance between rectus abdominis in millimetres (mm) will be assessed with an ultrasound machine, using a high-resolution linear array transducer.
Measured: Immediately after the intervention
Rectus abdominis thickness
The rectus abdominis thickness in millimetres (mm) will be assessed with an ultrasound machine, using a high-resolution linear array transducer.
Measured: Baseline
Rectus abdominis thickness
The rectus abdominis thickness in millimetres (mm) will be assessed with an ultrasound machine, using a high-resolution linear array transducer.
Measured: Immediately after the intervention
Secondary outcomes (20)
Body composition
Body composition by means of Bioimpedance (Tanita DC-430MA, Tanita Corporation of America, Inc., Arlington Heights, IL, USA).
Measured: Baseline
Body composition
Body composition by means of Bioimpedance (Tanita DC-430MA, Tanita Corporation of America, Inc., Arlington Heights, IL, USA).
Measured: Immediately after the intervention
Strength of the abdominal flexor musculature
Strength of the abdominal flexor musculature by means of a dynamometer (Lafayette, Indiana, USA)
Measured: Baseline
Strength of the abdominal flexor musculature
Strength of the abdominal flexor musculature by means of a dynamometer (Lafayette, Indiana, USA)
Measured: Immediately after the intervention
Kinesiophobia
Kinesiophobia with the Tampa Scale of Kinesiophobia-11 questionnaire: It maintains items 1, 2, 3, 5, 6, 7, 10, 11, 13, 15, and 17 from the original 17-point scale, and its score ranges from 11-44, where the lowest 11 means no or negligible kinesiophobia, and the higher scores indicate an increasing degree of kinesiophobia
Measured: Baseline
Kinesiophobia
Kinesiophobia with the Tampa Scale of Kinesiophobia-11 questionnaire: It maintains items 1, 2, 3, 5, 6, 7, 10, 11, 13, 15, and 17 from the original 17-point scale, and its score ranges from 11-44, where the lowest 11 means no or negligible kinesiophobia, and the higher scores indicate an increasing degree of kinesiophobia
Measured: Immediately after the intervention
Body image
Body image using the Multidimensional Body Self Relations Questionnaire: It consists of 69 items each rated on a 5-point scale from 1 to 5 (strongly disagree-strongly agree). The higher the score, the greater the satisfaction with one's own body image, so the total score of the instrument requires reversing the score of the items that indicate dissatisfaction
Measured: Baseline
Body image
Body image using the Multidimensional Body Self Relations Questionnaire: It consists of 69 items each rated on a 5-point scale from 1 to 5 (strongly disagree-strongly agree). The higher the score, the greater the satisfaction with one's own body image, so the total score of the instrument requires reversing the score of the items that indicate dissatisfaction
Measured: Immediately after the intervention
Perception of change after the intervention
Perception of change after the intervention with the Patient Perception of Change after Treatment questionnaire. consisting of a verbal scale, with 7 points "very much improved", "much improved", "minimally improved", "no change", "minimally worse", "much worse", "very much worse".
Measured: Baseline
Perception of change after the intervention
Perception of change after the intervention with the Patient Perception of Change after Treatment questionnaire. consisting of a verbal scale, with 7 points "very much improved", "much improved", "minimally improved", "no change", "minimally worse", "much worse", "very much worse".
Measured: Immediately after the intervention
Linea alba thickness
Linea alba thickness in millimetres (mm) will be assessed with an ultrasound machine, using a high-resolution linear array transducer.
Measured: Baseline
Linea alba thickness
Linea alba thickness in millimetres (mm) will be assessed with an ultrasound machine, using a high-resolution linear array transducer.
Measured: Immediately after the intervention
Linea alba distortion index
Linea alba distortion index in millimetres (mm) will be assessed with an ultrasound machine, using a high-resolution linear array transducer.
Measured: Baseline
Linea alba distortion index
Linea alba distortion index in millimetres (mm) will be assessed with an ultrasound machine, using a high-resolution linear array transducer.
Measured: Immediately after the intervention
Stabilization capacity and resistance of the abdomino-lumbo-pelvic capsule
Stabilization capacity and resistance of the abdomino-lumbo-pelvic capsule, with a battery of validated maneuvers: gluteal bridge, gluteal bridge with unipodal support, lateral planks and horizontal plank.
The measurement unit is the second (s) for all maneuvers, and the time for each manoeuvre shall be averaged.
Measured: Baseline
Stabilization capacity and resistance of the abdomino-lumbo-pelvic capsule
Stabilization capacity and resistance of the abdomino-lumbo-pelvic capsule, with a battery of validated maneuvers: gluteal bridge, gluteal bridge with unipodal support, lateral planks and horizontal plank.
The measurement unit is the second (s) for all maneuvers, and the time for each manoeuvre shall be averaged.
Measured: Immediately after the intervention
Abdominal circumference
Abdominal circumference will be assessed by means of tape measure in centimetres (cm). Two measurements shall be taken and averaged.
Measured: Baseline
Abdominal circumference
Abdominal circumference will be assessed by means of tape measure in centimetres (cm). Two measurements shall be taken and averaged.
Measured: Immediately after the intervention
Abdominal fold
Abdominal fold will be assessed by means of a plicometer in milimetres (mm). Two measurements shall be taken and averaged.
Measured: Baseline
Abdominal fold
Abdominal fold will be assessed by means of a plicometer in milimetres (mm). Two measurements shall be taken and averaged.
Measured: Immediately 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 posted16 Feb 2023
- Study start16 Jan 2023
- Primary completion30 Sep 2025
- Study completion30 Oct 2025
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 Abdominal DiastasisStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (actual)
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
- Investigators
- Marta Inglés, PhD, Principal investigator, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05731479
- Sponsor's protocol ID
- 2524988
- Status last verified
- Jun 2026
- First submitted
- 26 Jan 2023
- Last updated
- 25 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gluppe SB, Engh ME, Bo K. Immediate Effect of Abdominal and Pelvic Floor Muscle Exercises on Interrecti Distance in Women With Diastasis Recti Abdominis Who Were Parous. Phys Ther. 2020 Aug 12;100(8):1372-1383. doi: 10.1093/ptj/pzaa070.
PubMed 32302393Keshwani N, Mathur S, McLean L. The impact of exercise therapy and abdominal binding in the management of diastasis recti abdominis in the early post-partum period: a pilot randomized controlled trial. Physiother Theory Pract. 2021 Sep;37(9):1018-1033. doi: 10.1080/09593985.2019.1675207. Epub 2019 Oct 23.
PubMed 31642725Thabet AA, Alshehri MA. Efficacy of deep core stability exercise program in postpartum women with diastasis recti abdominis: a randomised controlled trial. J Musculoskelet Neuronal Interact. 2019 Mar 1;19(1):62-68.
PubMed 30839304
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
- Effectiveness of a Radiofrequency Diathermy and Therapeutic Exercise Protocol in Women With Abdominal Diastasis. Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05731479
- Acronym / sponsor ID
- 2524988
- Conditions
- Abdominal Diastasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 16 Jan 2023 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Oct 2025 (actual)
- First posted
- 16 Feb 2023 (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.
Diastasis recti abdominis (DRA) is defined as the presence of divergence between the rectus abdominis muscles along the linea alba. DRA is associated with decreased abdominal strength and degraded health and physical functioning, which results in poorer body perception and satisfaction and negatively affects the quality of life in its multiple spheres (social, sexual and personal). Regarding the different treatment techniques for DRA, different treatments have been described, such as bandages, electrotherapy or therapeutic exercise, the latter being the most scientifically supported option to approach DRA conservatively. Exercise has shown positive effects on DRA severity, abdominal muscle thickness, abdominal strength and endurance, and quality of life in women with DRA.
Another treatment that has shown promising effects in various pathologies is radiofrequency diathermy using the Capacitive-Resistive Electrical Transfer system. The capacitive mode acts on soft tissues containing electrolytes such as muscles and vascular and lymphatic tissues. On the other hand, the resistive mode acts on tissues of higher density and fat and fiber content, such as bones, ligaments and tendons. It has been documented that this type of therapy acts favoring the vascularization of tissues, decreasing inflammation and favoring the processes of cellular repair and analgesia. Its beneficial effect on low back pain and various pelvic floor disorders has been studied. However, at present, there are no studies evaluating the effectiveness of this type of intervention in people with abdominal diastasis.
In view of the above, the objective of our study is to evaluate the effectiveness of a protocol based on therapeutic exercise preceded by a radiofrequency diathermy program on anthropometric parameters, anatomo-physiological parameters, functional parameters, and parameters related to psychological aspects in women with postpartum abdominal diastasis.
Detailed description
A longitudinal randomized controlled experimental study will be carried out. The sample will be composed of 34 postpartum women, randomly distributed in two groups: i) diathermy + exercise group (GDE) (n=17), and ii) placebo diathermy + exercise group (GPE) (n=17).
The evaluations will be performed at two time points: i) before the intervention (T1), and ii) after the last session (T2).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diathermy + exercise group | Experimental | Other: Diathermy + exercise groupApplication of diathermy and a therapeutic exercise protocol. |
| Diathermy placebo + exercise group | Placebo comparator | Other: Diathermy placebo + exercise groupApplication of the diathermy device without energy emission and a therapeutic exercise protocol. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women aged 18 to 45 years,
- 3 to 24 months postpartum
- Criteria of abdominal diastasis according to Beer's criteria (Beer et al.2009)
Key exclusion criteria (2 listed)
- Rejection to sign the informed consent form
- Presence of any metabolic, neurological or connective tissue disease, as well as cognitive alterations.
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 |
|---|---|---|
| Diathermy + exercise groupThe Diathermy + Exercise group will receive diathermy for 15 minutes, of which 5 minutes will be applied in the capacitive method and 10 minutes in the resistive method. You will then perform 20 minutes of the following exercises: 1) Bird-Dog, 2) Crunch, 3) Obliques, 4) Drawing, 5) Half plank and 6) Side-plank. You will perform 8-12 repetitions and 3 sets of each exercise. 3 sessions of 35 minutes per week for 8 weeks. | Other | Diathermy + exercise group |
| Diathermy placebo + exercise groupThe Placebo + Exercise group will receive 15 minutes of application of the diathermy device without energy emission. It will then perform the same therapeutic exercise protocol described in the GDE. 3 sessions of 35 minutes per week for 8 weeks. | Other | Diathermy placebo + exercise group |
Primary outcome
Rectus abdominis distance
Time frame: Baseline
The distance between rectus abdominis in millimetres (mm) will be assessed with an ultrasound machine, using a high-resolution linear array transducer.
Rectus abdominis distance
Time frame: Immediately after the intervention
The distance between rectus abdominis in millimetres (mm) will be assessed with an ultrasound machine, using a high-resolution linear array transducer.
Rectus abdominis thickness
Time frame: Baseline
The rectus abdominis thickness in millimetres (mm) will be assessed with an ultrasound machine, using a high-resolution linear array transducer.
Rectus abdominis thickness
Time frame: Immediately after the intervention
The rectus abdominis thickness in millimetres (mm) will be assessed with an ultrasound machine, using a high-resolution linear array transducer.
20 secondary outcomes
Body composition
Time frame: Baseline
Body composition
Time frame: Immediately after the intervention
Strength of the abdominal flexor musculature
Time frame: Baseline
Strength of the abdominal flexor musculature
Time frame: Immediately after the intervention
Kinesiophobia
Time frame: Baseline
Kinesiophobia
Time frame: Immediately after the intervention
Body image
Time frame: Baseline
Body image
Time frame: Immediately after the intervention
Perception of change after the intervention
Time frame: Baseline
Perception of change after the intervention
Time frame: Immediately after the intervention
Linea alba thickness
Time frame: Baseline
Linea alba thickness
Time frame: Immediately after the intervention
Linea alba distortion index
Time frame: Baseline
Linea alba distortion index
Time frame: Immediately after the intervention
Stabilization capacity and resistance of the abdomino-lumbo-pelvic capsule
Time frame: Baseline
Stabilization capacity and resistance of the abdomino-lumbo-pelvic capsule
Time frame: Immediately after the intervention
Abdominal circumference
Time frame: Baseline
Abdominal circumference
Time frame: Immediately after the intervention
Abdominal fold
Time frame: Baseline
Abdominal fold
Time frame: Immediately after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Background: PubMed 32302393Gluppe SB, Engh ME, Bo K. Immediate Effect of Abdominal and Pelvic Floor Muscle Exercises on Interrecti Distance in Women With Diastasis Recti Abdominis Who Were Parous. Phys Ther. 2020 Aug 12;100(8):1372-1383. doi: 10.1093/ptj/pzaa070.
- Background: PubMed 31642725Keshwani N, Mathur S, McLean L. The impact of exercise therapy and abdominal binding in the management of diastasis recti abdominis in the early post-partum period: a pilot randomized controlled trial. Physiother Theory Pract. 2021 Sep;37(9):1018-1033. doi: 10.1080/09593985.2019.1675207. Epub 2019 Oct 23.
- Background: PubMed 30839304Thabet AA, Alshehri MA. Efficacy of deep core stability exercise program in postpartum women with diastasis recti abdominis: a randomised controlled trial. J Musculoskelet Neuronal Interact. 2019 Mar 1;19(1):62-68.
- 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. This study is not recruiting at the moment.
Marta Inglés, PhD principal investigator
University of Valencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diathermy + exercise group in people with Abdominal 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 2 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: finished, 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rectus abdominis distance (time frame: Baseline). The study lists 4 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 NCT05731479, 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.