Clinical trial NCT05731479: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Abdominal Diastasis
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2023-02-16
Enrollment: 34
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Rectus abdominis distance
timeFrame: Baseline
measure: Rectus abdominis distance
timeFrame: Immediately after the intervention
measure: Rectus abdominis thickness
timeFrame: Baseline
measure: Rectus abdominis thickness
timeFrame: Immediately after the intervention
Secondary outcomes:
measure: Body composition
timeFrame: Baseline
measure: Body composition
timeFrame: Immediately after the intervention
measure: Strength of the abdominal flexor musculature
timeFrame: Baseline
measure: Strength of the abdominal flexor musculature
timeFrame: Immediately after the intervention
measure: Kinesiophobia
timeFrame: Baseline
measure: Kinesiophobia
timeFrame: Immediately after the intervention
measure: Body image
timeFrame: Baseline
measure: Body image
timeFrame: Immediately after the intervention
measure: Perception of change after the intervention
timeFrame: Baseline
measure: Perception of change after the intervention
timeFrame: Immediately after the intervention
measure: Linea alba thickness
timeFrame: Baseline
measure: Linea alba thickness
timeFrame: Immediately after the intervention
measure: Linea alba distortion index
timeFrame: Baseline
measure: Linea alba distortion index
timeFrame: Immediately after the intervention
measure: Stabilization capacity and resistance of the abdomino-lumbo-pelvic capsule
timeFrame: Baseline
measure: Stabilization capacity and resistance of the abdomino-lumbo-pelvic capsule
timeFrame: Immediately after the intervention
measure: Abdominal circumference
timeFrame: Baseline
measure: Abdominal circumference
timeFrame: Immediately after the intervention
measure: Abdominal fold
timeFrame: Baseline
measure: Abdominal fold
timeFrame: Immediately after the intervention
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Faculty of Physiotherapy. University of Valencia
Study officials:
affiliation: University of Valencia
name: Marta Inglés, PhD
role: PRINCIPAL_INVESTIGATOR
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.
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.
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.