Radiofrequency Diathermy and Therapeutic Exercise Protocol in Women With Abdominal Diastasis

NCT05731479 | Recruiting

• 1 other identifier: 2524988
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Abdominal Diastasis

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (20)

• Body composition

  Baseline

• Body composition

  Immediately after the intervention

• Strength of the abdominal flexor musculature

  Baseline

• Strength of the abdominal flexor musculature

  Immediately after the intervention

• Kinesiophobia

  Baseline

Study Arms (2)

Diathermy + exercise group

EXPERIMENTAL

Application of diathermy and a therapeutic exercise protocol.

Other: Diathermy + exercise group

Diathermy placebo + exercise group

PLACEBO COMPARATOR

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

Other: Diathermy placebo + exercise group

Interventions

Diathermy + exercise group OTHER

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 + exercise group

Diathermy placebo + exercise group OTHER

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.

Diathermy placebo + exercise group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

Faculty of Physiotherapy. University of Valencia

Valencia, 46002, Spain

RECRUITING

Related 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.

  PMID: 32302393 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Interventions

Diathermy

Intervention Hierarchy (Ancestors)

Hyperthermia, Induced; Therapeutics

Study Officials

• Marta Inglés, PhD

  University of Valencia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marta Inglés, PhD

CONTACT

686320380; marta.ingles@uv.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2023
• First Posted: February 16, 2023
• Study Start: January 16, 2023
• Primary Completion: June 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 17, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)