Effects of Shockwave Therapy Versus Radiofrequency

Cardiovascular Risk Factor Clinical Trial

Official title:

Effect of an Aerobic Exercise Program Associated With Shock Wave Therapy Versus Radiofrequency on Skin and Subcutaneous Tissue: Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04282057
• Other study ID #: AN-009
• Status: Completed
• Phase: N/A
• Start date: February 22, 2020
• Est. completion date: June 19, 2020

Study information

• Verified date: September 2020
• Source: Escola Superior de Tecnologia da Saúde do Porto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main objective of this study is to compare the effect of 6 sessions of shock wave therapy versus radiofrequency followed by a protocol of moderate aerobic exercise, in the reduction of adiposity and abdominal flaccidity, in females between 18 and 60 years old. As a secondary objective, it is intended to understand the mechanism of fat mobilization by these two therapies.

Description:

With the increasing awareness of the population regarding the high rate of obesity and the number of deaths per year as a result of being overweight, treatments for reducing measures are increasingly sought.

The evidence shows that the accumulation of fat located in the abdominal region is a risk factor for dyslipidemia and arterial hypertension, and a reduction in waist circumference can reduce the potential risk of cardiovascular disease.

In addition to this concern, with the aging of the population and changes in body dimensions due to pregnancy or to a weight loss process, body flaccidity is also a growing cosmetic complaint, and the result is a less firm and pending skin.

Physical exercise is a very important agent for combating excess weight, with special attention to aerobic physical exercise, which is able to decrease body fat tissue and increase the oxidation of fatty acids by 5 to 10 times more than in resting state. The evidence points out that the exercise prescription to decrease fat mass should focus on a high volume of training (30 to 60 minutes) with moderate intensity (40 to 60% of Heart Rate Reserve), performed regularly and mobilizing large muscle groups.

In order to combat abdominal adiposity, as well as the flaccidity of the region, radiofrequency is presented as a possible complementary strategy.

Radiofrequency is an electromagnetic wave that when applied to skin, generates oscillating magnetic fields that move electrically charged particles producing heat in the tissues. The amount of heat produced is dependent on resistance.

Shock wave therapy consists of the application of high energy acoustic waves whose main characteristic is the production of a high pressure pulse induced in a short period of time. This will generate mechanical pressure waves in the tissues, promoting cavitation, with the formation of gas bubbles in the intervening fluids and an increase in local temperature.

The main objective of this study is to compare the effect of 6 sessions of shock wave therapy versus radiofrequency followed by a protocol of moderate aerobic exercise, in the reduction of adiposity and abdominal flaccidity, in females between 18 and 60 years old. As a secondary objective, it is intended to understand the mechanism of fat mobilization by these two therapies.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 19, 2020
• Est. primary completion date: April 25, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Women aged 18 to 60 years

Exclusion Criteria:

• smoking and drinking habits;

• athletes;

• people with dietary restrictions;

• participants who have had diets to lose weight in the last 3 months or who will start during the study;

• pregnant women;

• in postpartum less than one year;

• breastfeeding;

• intending to become pregnant during the study period;

• patients with electronic or metallic devices (pacemaker, IUD);

• individuals with metabolic (including dyslipidemias);

• hematological and renal disorders;

• individuals with dermatological changes;

• cardiovascular, respiratory, digestive, orthopedic, rheumatological and oncological pathologies;

• changes in the immune system or with acute inflammatory processes;

• changes in sensitivity or subject to medication (anti-coagulants, corticosteroids up to 6 weeks before, non-steroidal anti-inflammatory drugs, antihistamines, diuretics)

Related Conditions & MeSH terms

• Cardiovascular Risk Factor
• Metabolic Disease
• Metabolic Diseases
• Photoaging

Intervention

Device:
• Radiofrequency
Radiofrequency protocol - The radiofrequency protocol was performed in dorsal decubitus, with the head elevated at 45 degrees. The application was in capacitive mode, with a 7cm electrode, always in movement. The duration of the application was established in 15 minutes, maintaining the local temperature between 40 to 42 celsius degrees at the epidermis.
• Aerobic exercise
Aerobic exercise protocol - 40 minutes of aerobic moderate-intensity exercise (45-55% of reserve heart rate) using Karvonen's formula, performed on a cycloergometer. The duration of the exercise was divided into three parts: warm-up (5 minutes); body (30 minutes); and cooling (from 5 to 10 minutes). The entire protocol was monitored through the Polar® brand heart rate monitor and watch.
• Shock wave therapy
The shock wave device corresponds to the BTL-6000 X-Wave TM with a 20mm transmitter multifocal. The parameters used correspond to the pressure set between 2.8 and 3.5 bar, frequency 15 hertz and 3000 pulses per 10x15 cm area. It was used as a means contact gel for ultrasound, reference 033-051. In this procedure the participants found themselves in the supine position, with a pillow under the head and with the bending knees.

Locations

Country	Name	City	State
Portugal	Andreia Noites	Vila Nova de Gaia	Porto

Sponsors (1)

Lead Sponsor	Collaborator
Escola Superior de Tecnologia da Saúde do Porto

Country where clinical trial is conducted

Portugal, 

References & Publications (4)

Adatto MA, Adatto-Neilson R, Novak P, Krotz A, Haller G. Body shaping with acoustic wave therapy AWT(®)/EPAT(®): randomized, controlled study on 14 subjects. J Cosmet Laser Ther. 2011 Dec;13(6):291-6. doi: 10.3109/14764172.2011.630089. — View 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. Review. — View Citation

Noites A, Vale AL, Pereira AS, Morais A, Vilarinho R, Carvalho P, Amorim M, Moreira T, Mendonça A. Effect of an aerobic exercise session combined with abdominal radiofrequency on lipolytic activity in women: Randomized control trial. J Cosmet Dermatol. 2020 Mar;19(3):638-645. doi: 10.1111/jocd.13056. Epub 2019 Jun 29. — View Citation

Vale AL, Pereira AS, Morais A, de Carvalho P, Vilarinho R, Mendonça A, Noites A. Effect of four sessions of aerobic exercise with abdominal radiofrequency in adipose tissue in healthy women: Randomized control trial. J Cosmet Dermatol. 2020 Feb;19(2):359-367. doi: 10.1111/jocd.13036. Epub 2019 Jun 3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cutaneous abdominal tissue thickness	Measurement of the cutaneous fold by ultrasonography	Baseline
Primary	Cutaneous abdominal tissue thickness	Measurement of the cutaneous fold by ultrasonography	3 weeks after
Primary	Cutaneous abdominal tissue thickness	Measurement of the cutaneous fold by ultrasonography	6 weeks after
Primary	Subcutaneous abdominal tissue thickness	Measurement of the subcutaneous adipose fold by ultrasonography	Baseline
Primary	Subcutaneous abdominal tissue thickness	Measurement of the subcutaneous adipose fold by ultrasonography	3 weeks after
Primary	Subcutaneous abdominal tissue thickness	Measurement of the subcutaneous adipose fold by ultrasonography	6 weeks after
Primary	Glycerol concentration	Blood analysis collection carried out with help from an clinical analysis technician	Baseline
Primary	Glycerol concentration	Blood analysis collection carried out with help from an clinical analysis technician	3 weeks after
Primary	Glycerol concentration	Blood analysis collection carried out with help from an clinical analysis technician	6 weeks after
Primary	Lipid profile (LDL, HDL and triglyceride concentrations)	Blood analysis collection carried out with help from an clinical analysis technician	Baseline
Primary	Lipid profile (LDL, HDL and triglyceride concentrations)	Blood analysis collection carried out with help from an clinical analysis technician	3 weeks after
Primary	Lipid profile (LDL, HDL and triglyceride concentrations)	Blood analysis collection carried out with help from an clinical analysis technician	6 weeks after
Primary	Perimetry	Perimetry consists of measuring circumferences. In this case, of the waist at the navel area, 3 cm below it and in the hip area	Baseline
Primary	Perimetry	Perimetry consists of measuring circumferences. In this case, of the waist at the navel area, 3 cm below it and in the hip area	3 weeks after
Primary	Perimetry	Perimetry consists of measuring circumferences. In this case, of the waist at the navel area, 3 cm below it and in the hip area	6 weeks after
Primary	Adipometry	Adipometry consists of measuring skinfold thickness	Baseline
Primary	Adipometry	Adipometry consists of measuring skinfold thickness	3 weeks after
Primary	Adipometry	Adipometry consists of measuring skinfold thickness	6 weeks after
Primary	Inflammatory markers concentration (IL6, CRP, TNF)	Blood analysis collection carried out with help from an clinical analysis technician	Baseline
Primary	Inflammatory markers concentration (IL6, CRP, TNF)	Blood analysis collection carried out with help from an clinical analysis technician	3 weeks after
Primary	Inflammatory markers concentration (IL6, CRP, TNF)	Blood analysis collection carried out with help from an clinical analysis technician	6 weeks after
Primary	Nitrous oxide concentration	Blood analysis collection carried out with help from an clinical analysis technician	Baseline
Primary	Nitrous oxide concentration	Blood analysis collection carried out with help from an clinical analysis technician	3 weeks after
Primary	Nitrous oxide concentration	Blood analysis collection carried out with help from an clinical analysis technician	6 weeks after
Primary	Body composition- body mass	body mass in kilograms	Baseline
Primary	Body composition- body mass	body mass in kilograms	3 weeks after
Primary	Body composition- body mass	body mass in kilograms	6 weeks after
Primary	Body composition- muscle mass	muscle mass in kilograms	Baseline
Primary	Body composition- muscle mass	muscle mass in kilograms	3 weeks after
Primary	Body composition- muscle mass	muscle mass in kilograms	6 weeks after
Primary	Body composition- fat mass	fat mass in kilograms	Baseline
Primary	Body composition- fat mass	fat mass in kilograms	3 weeks after
Primary	Body composition- fat mass	fat mass in kilograms	6 weeks after
Primary	Body composition- visceral fat	visceral fat	Baseline
Primary	Body composition- visceral fat	visceral fat	3 weeks after
Primary	Body composition- visceral fat	visceral fat	6 weeks after
Primary	Body composition- fat body areas	percentage of fat distributed by body areas	Baseline
Primary	Body composition- fat body areas	percentage of fat distributed by body areas	3 weeks after
Primary	Body composition- fat body areas	percentage of fat distributed by body areas	6 weeks after
Primary	Thermography	Thermography is used to assess the temperature of the skin surface, and it is also possible to suppose changes in blood flow and vascularization with this outcome	Baseline
Primary	Thermography	Thermography is used to assess the temperature of the skin surface, and it is also possible to suppose changes in blood flow and vascularization with this outcome	3 weeks after
Primary	Thermography	Thermography is used to assess the temperature of the skin surface, and it is also possible to suppose changes in blood flow and vascularization with this outcome	6 weeks after
Primary	Photography	Photography is used to compare the before and after images. With these it is possible to evaluate the skin flaccidity and fat	Baseline
Primary	Photography	Photography is used to compare the before and after images. With these it is possible to evaluate the skin flaccidity and fat	3 weeks after
Primary	Photography	Photography is used to compare the before and after images. With these it is possible to evaluate the skin flaccidity and fat	6 weeks after
Secondary	skin flaccidity	Investigator Assessment Skin Laxity Scoring System - Questionnaire that evaluates skin flaccidity and scores from 0 to 4. (As the subjectivity assessment of this outcome, the investigator who evaluates is blind to the group that the participants are allocated, in order to avoid partial scores)	Baseline
Secondary	skin flaccidity	Investigator Assessment Skin Laxity Scoring System - Questionnaire that evaluates skin flaccidity and scores from 0 to 4. (As the subjectivity assessment of this outcome, the investigator who evaluates is blind to the group that the participants are allocated, in order to avoid partial scores)	3 weeks after
Secondary	skin flaccidity	Investigator Assessment Skin Laxity Scoring System - Questionnaire that evaluates skin flaccidity and scores from 0 to 4. (As the subjectivity assessment of this outcome, the investigator who evaluates is blind to the group that the participants are allocated, in order to avoid partial scores)	6 weeks after
Secondary	skin flaccidity and localized fat in the abdomen region	Satisfaction questionnaire to evaluate the final results according to the participant	Baseline
Secondary	skin flaccidity and localized fat in the abdomen region	Satisfaction questionnaire to evaluate the final results according to the participant	3 weeks after
Secondary	skin flaccidity and localized fat in the abdomen region	Satisfaction questionnaire to evaluate the final results according to the participant	6 weeks after