Clinical trial NCT03986983: Shockwave Therapy (SWT)
Official title: Effect of Shockwave Therapy Associated With an Aerobic Exercise Program on the Degree of Severity of Gynoid Lipodystrophy in Women: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gynoid Lipodystrophy
Keywords: Gynoid Lipodystrophy
Shock Wave Therapy
Aerobic Exercise
Lead sponsor: Escola Superior de Tecnologia da Saúde do Porto
Sponsor class: OTHER
First posted: 2019-06-14
Enrollment: 45
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the present study is to evaluate the effects of six sessions of aerobic exercise associated with shock waves therapy in the severity of gynoid lipodystrophy.

Detailed description: The Gynoid Lipodystrophy (GL) is considered to be a subcutaneous tissue disorder that causes changes in visible skin topography in the form of protrusions and depressions, mainly located in the lower limbs and abdominal region. It is a non-inflammatory and degenerative condition whose etiology has not been fully elucidated until now, although it can be explained by varied theories: the hormonal ,that is related to estrogen, the morphological one, based on alterations of the adipose tissue that is related to the interlobular septa of connective tissue that interconnects the subcutaneous adipose lobes, these septa are thin and have perpendicular projections, which favors the deposition of adipose tissue and its expansion to the surface of the dermis. The last one is about microcirculation deficits that can lead to intracellular edema and reduction of lymphatic drainage.

Shock wave therapy appears to be a safe and effective therapy to act in this disorder. It generates mechanical pressure waves in the tissues, promoting cavitation phenomena that produces lipolysis by destroying the cell membrane of adipocytes, increasing blood flow in the region, and stimulating lymphatic drainage.

On the other hand, there are studies that report that improvement in the appearance of GL is associated with a decrease in subcutaneous adipose tissue. Physiologically, aerobic physical exercise has the capacity to decrease body fat, taking into account that the oxidation reactions of fatty acids are enhanced, with moderate intensity exercise.

In this sense, it may be beneficial to associate Shockwave Therapy and Physical Exercise to reduce GL severity, so this study aims to analyze the effect of radial shock wave therapy in association with the performance of an aerobic exercise program, in female subjects, in the degree of GL severity in the gluteal region and ⅓ proximal posterior of the thighs.

Eligibility criteria: Inclusion Criteria:

* Participants with a moderate and severe degree of cellulitis, according to an CSS, in the region of the buttocks and ⅓ proximal posterior of the thighs;

Exclusion Criteria:

* Unstable weight during the last 6 months, with a variation of less than or equal to 2 kg has been initiated;
* Hormonal treatment (contraceptive pill, intrauterine device, other) changed in the last 6 months;
* Participants with food restrictions;
* Pregnant women or post childbirth during the last year;

Primary outcomes:
measure: Change in the score of the Cellulite Severity Scale (CSS)
timeFrame: before the intervention program
Secondary outcomes:
measure: Subcutaneous buttock tissue thickness
timeFrame: before the intervention program
measure: Changes in anthropometric measurements such as hip circumference, gluteal fold, and the proximal ⅓ of the thigh
timeFrame: before the intervention program
measure: Change in the microcirculation of the treatment area
timeFrame: before the intervention program
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: Andreia Noites
Study officials:
References:
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citation: Modena DAO, da Silva CN, Grecco C, Guidi RM, Moreira RG, Coelho AA, Sant'Ana E, de Souza JR. Extracorporeal shockwave: mechanisms of action and physiological aspects for cellulite, body shaping, and localized fat-Systematic review. J Cosmet Laser Ther. 2017 Oct;19(6):314-319. doi: 10.1080/14764172.2017.1334928. Epub 2017 Jun 7.
citation: Perez Atamoros FM, Alcala Perez D, Asz Sigall D, Avila Romay AA, Barba Gastelum JA, de la Pena Salcedo JA, Escalante Salgado PE, Gallardo Palacios GJ, Guerrero-Gonzalez GA, Morales De la Cerda R, Ponce Olivera RM, Rossano Soriano F, Solis Tinoco E, Welsh Hernandez EC. Evidence-based treatment for gynoid lipodystrophy: A review of the recent literature. J Cosmet Dermatol. 2018 Dec;17(6):977-983. doi: 10.1111/jocd.12555. Epub 2018 Apr 30.