## Protocol Section
### Identification Module
**NCT ID:** NCT05731479

**Brief Title:** Radiofrequency Diathermy and Therapeutic Exercise Protocol in Women With Abdominal Diastasis

**Official Title:** Effectiveness of a Radiofrequency Diathermy and Therapeutic Exercise Protocol in Women With Abdominal Diastasis. Randomized Controlled Trial

#### Organization Study ID Info
**ID:** 2524988
#### Organization
**Class:** OTHER
**Full Name:** University of Valencia
### Status Module
#### Completion Date
**Date:** 2026-06

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-03-17

**Type:** ACTUAL

**Last Update Submit Date:** 2023-03-14

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-06

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-01-16

**Type:** ACTUAL

**Status Verified Date:** 2022-12

#### Study First Post Date
**Date:** 2023-02-16
**Type:** ACTUAL
**Study First Submit Date:** 2023-01-26
**Study First Submit QC Date:** 2023-02-07
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Valencia

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief 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 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).

### Conditions Module

**Conditions:**

- Abdominal Diastasis

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 34

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Application of diathermy and a therapeutic exercise protocol.

**Intervention Names:**

- Other: Diathermy + exercise group

**Label:** Diathermy + exercise group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Application of the diathermy device without energy emission and a therapeutic exercise protocol.

**Intervention Names:**

- Other: Diathermy placebo + exercise group

**Label:** Diathermy placebo + exercise group

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Diathermy + exercise group

**Description:** 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.

**Name:** Diathermy + exercise group

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Diathermy placebo + exercise group

**Description:** 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.

**Name:** Diathermy placebo + exercise group

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** The distance between rectus abdominis in millimetres (mm) will be assessed with an ultrasound machine, using a high-resolution linear array transducer.

**Measure:** Rectus abdominis distance

**Time Frame:** Baseline

**Description:** The distance between rectus abdominis in millimetres (mm) will be assessed with an ultrasound machine, using a high-resolution linear array transducer.

**Measure:** Rectus abdominis distance

**Time Frame:** Immediately after the intervention

**Description:** The rectus abdominis thickness in millimetres (mm) will be assessed with an ultrasound machine, using a high-resolution linear array transducer.

**Measure:** Rectus abdominis thickness

**Time Frame:** Baseline

**Description:** The rectus abdominis thickness in millimetres (mm) will be assessed with an ultrasound machine, using a high-resolution linear array transducer.

**Measure:** Rectus abdominis thickness

**Time Frame:** Immediately after the intervention

#### Secondary Outcomes

**Description:** Body composition by means of Bioimpedance (Tanita DC-430MA, Tanita Corporation of America, Inc., Arlington Heights, IL, USA).

**Measure:** Body composition

**Time Frame:** Baseline

**Description:** Body composition by means of Bioimpedance (Tanita DC-430MA, Tanita Corporation of America, Inc., Arlington Heights, IL, USA).

**Measure:** Body composition

**Time Frame:** Immediately after the intervention

**Description:** Strength of the abdominal flexor musculature by means of a dynamometer (Lafayette, Indiana, USA)

**Measure:** Strength of the abdominal flexor musculature

**Time Frame:** Baseline

**Description:** Strength of the abdominal flexor musculature by means of a dynamometer (Lafayette, Indiana, USA)

**Measure:** Strength of the abdominal flexor musculature

**Time Frame:** Immediately after the intervention

**Description:** 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

**Measure:** Kinesiophobia

**Time Frame:** Baseline

**Description:** 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

**Measure:** Kinesiophobia

**Time Frame:** Immediately after the intervention

**Description:** 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

**Measure:** Body image

**Time Frame:** Baseline

**Description:** 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

**Measure:** Body image

**Time Frame:** Immediately after the intervention

**Description:** 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".

**Measure:** Perception of change after the intervention

**Time Frame:** Baseline

**Description:** 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".

**Measure:** Perception of change after the intervention

**Time Frame:** Immediately after the intervention

**Description:** Linea alba thickness in millimetres (mm) will be assessed with an ultrasound machine, using a high-resolution linear array transducer.

**Measure:** Linea alba thickness

**Time Frame:** Baseline

**Description:** Linea alba thickness in millimetres (mm) will be assessed with an ultrasound machine, using a high-resolution linear array transducer.

**Measure:** Linea alba thickness

**Time Frame:** Immediately after the intervention

**Description:** Linea alba distortion index in millimetres (mm) will be assessed with an ultrasound machine, using a high-resolution linear array transducer.

**Measure:** Linea alba distortion index

**Time Frame:** Baseline

**Description:** Linea alba distortion index in millimetres (mm) will be assessed with an ultrasound machine, using a high-resolution linear array transducer.

**Measure:** Linea alba distortion index

**Time Frame:** Immediately after the intervention

**Description:** 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.

**Measure:** Stabilization capacity and resistance of the abdomino-lumbo-pelvic capsule

**Time Frame:** Baseline

**Description:** 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.

**Measure:** Stabilization capacity and resistance of the abdomino-lumbo-pelvic capsule

**Time Frame:** Immediately after the intervention

**Description:** Abdominal circumference will be assessed by means of tape measure in centimetres (cm). Two measurements shall be taken and averaged.

**Measure:** Abdominal circumference

**Time Frame:** Baseline

**Description:** Abdominal circumference will be assessed by means of tape measure in centimetres (cm). Two measurements shall be taken and averaged.

**Measure:** Abdominal circumference

**Time Frame:** Immediately after the intervention

**Description:** Abdominal fold will be assessed by means of a plicometer in milimetres (mm). Two measurements shall be taken and averaged.

**Measure:** Abdominal fold

**Time Frame:** Baseline

**Description:** Abdominal fold will be assessed by means of a plicometer in milimetres (mm). Two measurements shall be taken and averaged.

**Measure:** Abdominal fold

**Time Frame:** Immediately after the intervention

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Women aged 18 to 45 years,
* 3 to 24 months postpartum
* Criteria of abdominal diastasis according to Beer's criteria (Beer et al.2009)

Exclusion Criteria:

* Rejection to sign the informed consent form
* Presence of any metabolic, neurological or connective tissue disease, as well as cognitive alterations.

**Maximum Age:** 45 Years

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** marta.ingles@uv.es

**Name:** Marta Inglés, PhD

**Phone:** 686320380

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Valencia

**Contacts:**

***Contact 1:***

- **Email:** marta.ingles@uv.es

- **Name:** Marta Inglés, PhD

- **Role:** CONTACT

***Contact 2:***

- **Email:** elena.munoz-gomez@uv.es

- **Name:** Elena Muñoz Gómez, PhD

- **Role:** CONTACT

**Country:** Spain

**Facility:** Faculty of Physiotherapy. University of Valencia

**Status:** RECRUITING

**Zip:** 46002

#### Overall Officials

**Official 1:**

**Affiliation:** University of Valencia

**Name:** Marta Inglés, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**Citation:** 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.

**PMID:** 32302393

**Citation:** Keshwani 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.

**PMID:** 31642725

**Citation:** Thabet 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.

**PMID:** 30839304

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014947

- Term: Wounds and Injuries

- ID: D000004204

- Term: Joint Dislocations

- ID: D000007592

- Term: Joint Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: All

- Name: All Conditions

- Abbrev: BC05

- Name: Musculoskeletal Diseases

### Condition Browse Module - Browse Leaves

- ID: M2454

- Name: Hyperthermia

- Relevance: LOW

- As Found: Unknown

- ID: M618

- Name: Diastasis, Muscle

- Relevance: HIGH

- As Found: Abdominal Diastasis

- ID: M17685

- Name: Wounds and Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M7385

- Name: Joint Dislocations

- Relevance: LOW

- As Found: Unknown

- ID: M10621

- Name: Joint Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000070630

- Term: Diastasis, Muscle

### Misc Info Module

- Version Holder: 2024-05-24
