Shockwave Therapy (SWT)

NCT03986983 | Completed DMC

• 1 other identifier: AN-008
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Gynoid Lipodystrophy

Keywords

Gynoid Lipodystrophy; Shock Wave Therapy; Aerobic Exercise

Outcome Measures

Primary Outcomes (1)

• 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.

  before the intervention program

Secondary Outcomes (3)

• Subcutaneous buttock tissue thickness

  before the intervention program

• Changes in anthropometric measurements such as hip circumference, gluteal fold, and the proximal ⅓ of the thigh

  before the intervention program

• Change in the microcirculation of the treatment area

  before the intervention program

Study Arms (3)

Experimental group of Aerobic exercise

EXPERIMENTAL

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

Other: Aerobic exercise

Experimental group of Shockwave therapy and Aerobic Exercise

EXPERIMENTAL

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.

Device: Shockwave therapy; Other: Aerobic exercise

Control group

NO INTERVENTION

The participants do not perform any type of intervention.

Interventions

Shockwave therapy DEVICE

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.

Experimental group of Shockwave therapy and Aerobic Exercise

Aerobic exercise OTHER

Aerobic exercise protocol - 30 minutes of aerobic moderate-intensity exercise (40% of reserve heart rate) using Karvonen´s formula, performed on a step.

Experimental group of Aerobic exercise; Experimental group of Shockwave therapy and Aerobic Exercise

Eligibility Criteria

• Age: 18 Years - 35 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Escola Superior de Tecnologia da Saúde do Porto: lead

Study Sites (1)

Andreia Noites

Porto, 4200-072, Portugal

Location

Related Publications (7)

• 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.

  PMID: 20590369 BACKGROUND

• 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

• 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.

  PMID: 19083577 BACKGROUND

• 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.

  PMID: 27997260 BACKGROUND

• 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.

  PMID: 24297647 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

• 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.

  PMID: 29707877 BACKGROUND

MeSH Terms

Interventions

Extracorporeal Shockwave Therapy; Exercise

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator- Integrated Researcher, Center for Rehabilitation Research (CIR) School of Health of P.PORTO.

Study Record Dates

• First Submitted: June 11, 2019
• First Posted: June 14, 2019
• Study Start: June 25, 2019
• Primary Completion: July 26, 2019
• Study Completion: July 26, 2019
• Last Updated: December 11, 2019

Record last verified: 2019-12

Locations

PT (1)