Radiofrequency Diathermy and Therapeutic Exercise Protocol in Women With Abdominal Diastasis

Abdominal Diastasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05731479
• Other study ID #: 2524988
• Status: Recruiting
• Phase: N/A
• Start date: January 16, 2023
• Est. completion date: June 2026

Study information

• Verified date: December 2022
• Source: University of Valencia
• Contact: Marta Inglés, PhD
• Phone: 686320380
• Email: marta.ingles[@]uv.es
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: June 2026
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Abdominal Diastasis
• Diastasis, Muscle

Intervention

Other:
• Diathermy + exercise group
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 group
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.

Locations

Country	Name	City	State
Spain	Faculty of Physiotherapy. University of Valencia	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
University of Valencia

Country where clinical trial is conducted

Spain, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline
Primary	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.	Immediately after the intervention
Primary	Rectus abdominis thickness	The rectus abdominis thickness in millimetres (mm) will be assessed with an ultrasound machine, using a high-resolution linear array transducer.	Baseline
Primary	Rectus abdominis thickness	The rectus abdominis thickness in millimetres (mm) will be assessed with an ultrasound machine, using a high-resolution linear array transducer.	Immediately after the intervention
Secondary	Body composition	Body composition by means of Bioimpedance (Tanita DC-430MA, Tanita Corporation of America, Inc., Arlington Heights, IL, USA).	Baseline
Secondary	Body composition	Body composition by means of Bioimpedance (Tanita DC-430MA, Tanita Corporation of America, Inc., Arlington Heights, IL, USA).	Immediately after the intervention
Secondary	Strength of the abdominal flexor musculature	Strength of the abdominal flexor musculature by means of a dynamometer (Lafayette, Indiana, USA)	Baseline
Secondary	Strength of the abdominal flexor musculature	Strength of the abdominal flexor musculature by means of a dynamometer (Lafayette, Indiana, USA)	Immediately after the intervention
Secondary	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	Baseline
Secondary	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	Immediately after the intervention
Secondary	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	Baseline
Secondary	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	Immediately after the intervention
Secondary	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".	Baseline
Secondary	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".	Immediately after the intervention
Secondary	Linea alba thickness	Linea alba thickness in millimetres (mm) will be assessed with an ultrasound machine, using a high-resolution linear array transducer.	Baseline
Secondary	Linea alba thickness	Linea alba thickness in millimetres (mm) will be assessed with an ultrasound machine, using a high-resolution linear array transducer.	Immediately after the intervention
Secondary	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.	Baseline
Secondary	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.	Immediately after the intervention
Secondary	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.	Baseline
Secondary	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.	Immediately after the intervention
Secondary	Abdominal circumference	Abdominal circumference will be assessed by means of tape measure in centimetres (cm). Two measurements shall be taken and averaged.	Baseline
Secondary	Abdominal circumference	Abdominal circumference will be assessed by means of tape measure in centimetres (cm). Two measurements shall be taken and averaged.	Immediately after the intervention
Secondary	Abdominal fold	Abdominal fold will be assessed by means of a plicometer in milimetres (mm). Two measurements shall be taken and averaged.	Baseline
Secondary	Abdominal fold	Abdominal fold will be assessed by means of a plicometer in milimetres (mm). Two measurements shall be taken and averaged.	Immediately after the intervention