Shockwave Therapy (SWT) (SWT)

December 10, 2019 updated by: Andreia Noites, Escola Superior de Tecnologia da Saúde do Porto

Effect of Shockwave Therapy Associated With an Aerobic Exercise Program on the Degree of Severity of Gynoid Lipodystrophy in Women: a Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
      • Porto, Portugal, 4200-072
        • Andreia Noites

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Experimental group of Aerobic exercise
The participants perform the Aerobic exercise protocol - The entire protocol was monitored through the Polar® brand heart rate monitor and watch.
Other: Aerobic exercise
Aerobic exercise protocol - 30 minutes of aerobic moderate-intensity exercise (40% of reserve heart rate) using Karvonen´s formula, performed on a step.
EXPERIMENTAL: Experimental group of Shockwave therapy and Aerobic Exercise

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.
Other: Aerobic exercise
Aerobic exercise protocol - 30 minutes of aerobic moderate-intensity exercise (40% of reserve heart rate) using Karvonen´s formula, performed on a step.
Device: Shockwave therapy
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.
NO_INTERVENTION: Control group
The participants do not perform any type of intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the score of the Cellulite Severity Scale (CSS)
Time Frame: before the intervention program
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.
before the intervention program

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subcutaneous buttock tissue thickness
Time Frame: before the intervention program
Verified by changes in the measurement of the subcutaneous adipose fold by ultrasonography (mm)
before the intervention program
Changes in anthropometric measurements such as hip circumference, gluteal fold, and the proximal ⅓ of the thigh
Time Frame: before the intervention program
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)
before the intervention program
Change in the microcirculation of the treatment area
Time Frame: before the intervention program
Verified by changes in the thermography (ºC)
before the intervention program

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Escola Superior de Tecnologia da Saúde do Porto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 25, 2019

Primary Completion (ACTUAL)

July 26, 2019

Study Completion (ACTUAL)

July 26, 2019

Study Registration Dates

First Submitted

June 11, 2019

First Submitted That Met QC Criteria

June 13, 2019

First Posted (ACTUAL)

June 14, 2019

Study Record Updates

Last Update Posted (ACTUAL)

December 11, 2019

Last Update Submitted That Met QC Criteria

December 10, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AN-008

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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