search
Back to results

Shockwave Therapy (SWT) (SWT)

Primary Purpose

Gynoid Lipodystrophy

Status
Completed
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Shockwave therapy
Aerobic exercise
Sponsored by
Escola Superior de Tecnologia da Saúde do Porto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gynoid Lipodystrophy focused on measuring Gynoid Lipodystrophy, Shock Wave Therapy, Aerobic Exercise

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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;

Sites / Locations

  • Andreia Noites

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Experimental group of Aerobic exercise

Experimental group of Shockwave therapy and Aerobic Exercise

Control group

Arm Description

The participants perform the Aerobic exercise protocol - The entire protocol was monitored through the Polar® brand heart rate monitor and watch.

The participants do the Shockwave therapy protocol - The shockwave therapy protocol was performed in the prone position. In addition, the participants also perform the Aerobic exercise protocol - The entire protocol was monitored through the Polar® brand heart rate monitor and watch.

The participants do not perform any type of intervention.

Outcomes

Primary Outcome Measures

Change in the score of the Cellulite Severity Scale (CSS)
Verified by changes in the score of the CSS. The CSS is used to measure the severity of GL, this scale quantifies 5 variables such as the number of evident depressions, the depth of depressions , the morphological aspect of the skin surface, the degree of laxity, flaccidity, or sagging skin and the classification of GL using the scale of Nurnberger and Muller. Each variable can have a score of 0 to 3 and the final score is made by the total sum of these. The final score goes from 0 to 15 , which means that 0 to 5 is a mild degree of GL, 6 to 10 is moderate degree and 11 to 15 is considered a severe degree.

Secondary Outcome Measures

Subcutaneous buttock tissue thickness
Verified by changes in the measurement of the subcutaneous adipose fold by ultrasonography (mm)
Changes in anthropometric measurements such as hip circumference, gluteal fold, and the proximal ⅓ of the thigh
Verified by changes in anthropometric measures such as hip circumference, gluteal fold, and the proximal ⅓ of the thigh before and after the intervention, evaluated using a tape measure (cm)
Change in the microcirculation of the treatment area
Verified by changes in the thermography (ºC)

Full Information

First Posted
June 11, 2019
Last Updated
December 10, 2019
Sponsor
Escola Superior de Tecnologia da Saúde do Porto
search

1. Study Identification

Unique Protocol Identification Number
NCT03986983
Brief Title
Shockwave Therapy (SWT)
Acronym
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

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
June 25, 2019 (Actual)
Primary Completion Date
July 26, 2019 (Actual)
Study Completion Date
July 26, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Escola Superior de Tecnologia da Saúde do Porto

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gynoid Lipodystrophy
Keywords
Gynoid Lipodystrophy, Shock Wave Therapy, Aerobic Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental group of Aerobic exercise
Arm Type
Experimental
Arm Description
The participants perform the Aerobic exercise protocol - The entire protocol was monitored through the Polar® brand heart rate monitor and watch.
Arm Title
Experimental group of Shockwave therapy and Aerobic Exercise
Arm Type
Experimental
Arm Description
The participants do the Shockwave therapy protocol - The shockwave therapy protocol was performed in the prone position. In addition, the participants also perform the Aerobic exercise protocol - The entire protocol was monitored through the Polar® brand heart rate monitor and watch.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The participants do not perform any type of intervention.
Intervention Type
Device
Intervention Name(s)
Shockwave therapy
Intervention Description
Shockwave therapy protocol - The shockwave therapy protocol was performed in the prone position. The application was radial shockwave with 3,5bar, 15Hz of frequency and 3000 impulses.
Intervention Type
Other
Intervention Name(s)
Aerobic exercise
Intervention Description
Aerobic exercise protocol - 30 minutes of aerobic moderate-intensity exercise (40% of reserve heart rate) using Karvonen´s formula, performed on a step.
Primary Outcome Measure Information:
Title
Change in the score of the Cellulite Severity Scale (CSS)
Description
Verified by changes in the score of the CSS. The CSS is used to measure the severity of GL, this scale quantifies 5 variables such as the number of evident depressions, the depth of depressions , the morphological aspect of the skin surface, the degree of laxity, flaccidity, or sagging skin and the classification of GL using the scale of Nurnberger and Muller. Each variable can have a score of 0 to 3 and the final score is made by the total sum of these. The final score goes from 0 to 15 , which means that 0 to 5 is a mild degree of GL, 6 to 10 is moderate degree and 11 to 15 is considered a severe degree.
Time Frame
before the intervention program
Secondary Outcome Measure Information:
Title
Subcutaneous buttock tissue thickness
Description
Verified by changes in the measurement of the subcutaneous adipose fold by ultrasonography (mm)
Time Frame
before the intervention program
Title
Changes in anthropometric measurements such as hip circumference, gluteal fold, and the proximal ⅓ of the thigh
Description
Verified by changes in anthropometric measures such as hip circumference, gluteal fold, and the proximal ⅓ of the thigh before and after the intervention, evaluated using a tape measure (cm)
Time Frame
before the intervention program
Title
Change in the microcirculation of the treatment area
Description
Verified by changes in the thermography (ºC)
Time Frame
before the intervention program

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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;
Facility Information:
Facility Name
Andreia Noites
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal

12. IPD Sharing Statement

Citations:
PubMed Identifier
20590369
Citation
Adatto M, Adatto-Neilson R, Servant JJ, Vester J, Novak P, Krotz A. Controlled, randomized study evaluating the effects of treating cellulite with AWT/EPAT. J Cosmet Laser Ther. 2010 Aug;12(4):176-82. doi: 10.3109/14764172.2010.500392.
Results Reference
background
PubMed Identifier
21981441
Citation
Adatto MA, Adatto-Neilson R, Novak P, Krotz A, Haller G. Body shaping with acoustic wave therapy AWT((R))/EPAT((R)): randomized, controlled study on 14 subjects. J Cosmet Laser Ther. 2011 Dec;13(6):291-6. doi: 10.3109/14764172.2011.630089.
Results Reference
background
PubMed Identifier
19083577
Citation
Christ C, Brenke R, Sattler G, Siems W, Novak P, Daser A. Improvement in skin elasticity in the treatment of cellulite and connective tissue weakness by means of extracorporeal pulse activation therapy. Aesthet Surg J. 2008 Sep-Oct;28(5):538-44. doi: 10.1016/j.asj.2008.07.011.
Results Reference
background
PubMed Identifier
27997260
Citation
Hexsel D, Camozzato FO, Silva AF, Siega C. Acoustic wave therapy for cellulite, body shaping and fat reduction. J Cosmet Laser Ther. 2017 Jun;19(3):165-173. doi: 10.1080/14764172.2016.1269928. Epub 2017 Feb 2.
Results Reference
background
PubMed Identifier
24297647
Citation
Knobloch K, Joest B, Kramer R, Vogt PM. Cellulite and focused extracorporeal shockwave therapy for non-invasive body contouring: a randomized trial. Dermatol Ther (Heidelb). 2013 Dec;3(2):143-55. doi: 10.1007/s13555-013-0039-5. Epub 2013 Dec 3.
Results Reference
background
PubMed Identifier
28590827
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.
Results Reference
background
PubMed Identifier
29707877
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.
Results Reference
background

Learn more about this trial

Shockwave Therapy (SWT)

We'll reach out to this number within 24 hrs