Effects of Shockwave Therapy Versus Radiofrequency

NCT04282057 | Completed DMC

• 1 other identifier: AN-009
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiovascular Risk Factor; Metabolic Disease; Photoaging

Keywords

shock wave therapy; radiofrequency; adipose tissue; skin flaccidity; aerobic exercise

Outcome Measures

Primary Outcomes (45)

• Cutaneous abdominal tissue thickness

  Measurement of the cutaneous fold by ultrasonography

  Baseline

• Cutaneous abdominal tissue thickness

  Measurement of the cutaneous fold by ultrasonography

  3 weeks after

• Cutaneous abdominal tissue thickness

  Measurement of the cutaneous fold by ultrasonography

  6 weeks after

• Subcutaneous abdominal tissue thickness

  Measurement of the subcutaneous adipose fold by ultrasonography

  Baseline

• Subcutaneous abdominal tissue thickness

  Measurement of the subcutaneous adipose fold by ultrasonography

  3 weeks after

• Subcutaneous abdominal tissue thickness

  Measurement of the subcutaneous adipose fold by ultrasonography

  6 weeks after

• Glycerol concentration

  Blood analysis collection carried out with help from an clinical analysis technician

  Baseline

• Glycerol concentration

  Blood analysis collection carried out with help from an clinical analysis technician

  3 weeks after

• Glycerol concentration

  Blood analysis collection carried out with help from an clinical analysis technician

  6 weeks after

• Lipid profile (LDL, HDL and triglyceride concentrations)

  Blood analysis collection carried out with help from an clinical analysis technician

  Baseline

• Lipid profile (LDL, HDL and triglyceride concentrations)

  Blood analysis collection carried out with help from an clinical analysis technician

  3 weeks after

• Lipid profile (LDL, HDL and triglyceride concentrations)

  Blood analysis collection carried out with help from an clinical analysis technician

  6 weeks after

• 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

• 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

• 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

• Adipometry

  Adipometry consists of measuring skinfold thickness

  Baseline

• Adipometry

  Adipometry consists of measuring skinfold thickness

  3 weeks after

• Adipometry

  Adipometry consists of measuring skinfold thickness

  6 weeks after

• Inflammatory markers concentration (IL6, CRP, TNF)

  Blood analysis collection carried out with help from an clinical analysis technician

  Baseline

• Inflammatory markers concentration (IL6, CRP, TNF)

  Blood analysis collection carried out with help from an clinical analysis technician

  3 weeks after

• Inflammatory markers concentration (IL6, CRP, TNF)

  Blood analysis collection carried out with help from an clinical analysis technician

  6 weeks after

• Nitrous oxide concentration

  Blood analysis collection carried out with help from an clinical analysis technician

  Baseline

• Nitrous oxide concentration

  Blood analysis collection carried out with help from an clinical analysis technician

  3 weeks after

• Nitrous oxide concentration

  Blood analysis collection carried out with help from an clinical analysis technician

  6 weeks after

• Body composition- body mass

  body mass in kilograms

  Baseline

• Body composition- body mass

  body mass in kilograms

  3 weeks after

• Body composition- body mass

  body mass in kilograms

  6 weeks after

• Body composition- muscle mass

  muscle mass in kilograms

  Baseline

• Body composition- muscle mass

  muscle mass in kilograms

  3 weeks after

• Body composition- muscle mass

  muscle mass in kilograms

  6 weeks after

• Body composition- fat mass

  fat mass in kilograms

  Baseline

• Body composition- fat mass

  fat mass in kilograms

  3 weeks after

• Body composition- fat mass

  fat mass in kilograms

  6 weeks after

• Body composition- visceral fat

  visceral fat

  Baseline

• Body composition- visceral fat

  visceral fat

  3 weeks after

• Body composition- visceral fat

  visceral fat

  6 weeks after

• Body composition- fat body areas

  percentage of fat distributed by body areas

  Baseline

• Body composition- fat body areas

  percentage of fat distributed by body areas

  3 weeks after

• Body composition- fat body areas

  percentage of fat distributed by body areas

  6 weeks after

• 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

• 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

• 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

• Photography

  Photography is used to compare the before and after images. With these it is possible to evaluate the skin flaccidity and fat

  Baseline

• 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

• 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 Outcomes (6)

• skin flaccidity

  Baseline

• skin flaccidity

  3 weeks after

• skin flaccidity

  6 weeks after

• skin flaccidity and localized fat in the abdomen region

  Baseline

• skin flaccidity and localized fat in the abdomen region

  3 weeks after

Study Arms (3)

shockwave therapy group

EXPERIMENTAL

This group performed aerobic exercise just after shock wave therapy in the abdominal region.

Device: Shock wave therapy

radiofrequency group

EXPERIMENTAL

This group performed aerobic exercise just after radiofrequency in the abdominal region.

Device: Radiofrequency

control group

ACTIVE COMPARATOR

This group only performed aerobic exercise.

Device: Aerobic exercise

Interventions

Radiofrequency DEVICE

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.

radiofrequency group

Aerobic exercise DEVICE

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.

control group

Shock wave therapy DEVICE

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.

shockwave therapy group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women aged 18 to 60 years

You may not qualify if:

• 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)

Sponsors & Collaborators

• Escola Superior de Tecnologia da Saúde do Porto: lead

Study Sites (1)

Andreia Noites

Vila Nova de Gaia, Porto District, 4400-330, Portugal

Location

Related Publications (4)

• 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.

  PMID: 21981441 BACKGROUND

• 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.

  PMID: 28590827 BACKGROUND

• Noites A, Vale AL, Pereira AS, Morais A, Vilarinho R, Carvalho P, Amorim M, Moreira T, Mendonca 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.

  PMID: 31254455 BACKGROUND

• Vale AL, Pereira AS, Morais A, de Carvalho P, Vilarinho R, Mendonca 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.

  PMID: 31157522 BACKGROUND

MeSH Terms

Conditions

Metabolic Diseases

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teacher

Study Record Dates

• First Submitted: February 18, 2020
• First Posted: February 24, 2020
• Study Start: February 22, 2020
• Primary Completion: April 25, 2020
• Study Completion: June 19, 2020
• Last Updated: September 30, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)