Phototherapy and Radiofrecuency for Cellulite

Cellulite Clinical Trial

Official title:

Analysis Phototherapy and Radiofrecuency Added to a Physical Therapy Program for Treatment of Cellulite

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT05441917
• Other study ID #: 11062022
• Status: Suspended
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: December 1, 2023

Study information

• Verified date: March 2023
• Source: Quiropraxia y Equilibrio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Cellulite is a condition that consists of an edematous infiltration of connective tissue. It has multiple factors in its etiology, making it difficult to choose just one type of treatment. Thus, aiming at greater therapeutic efficiency, the association of therapies is studied. This research aims to evaluate the Sanae method for the treatment of cellulite. The sample will feature 60 participants who have different degrees of cellulite. Initially, a pilot study will be carried out with 12 patients, divided into two groups: G1-P: 6 volunteers with grade 3 cellulite and G2-P: 6 volunteers with grade 2 cellulite. At the end of this step, the sample for the new step will include 48 people from female, who also have the same characteristics as the previous groups. Again they will be divided equally into two groups: G1: 24 volunteers with grade 3 cellulite and G2: 24 volunteers with grade 2 cellulite. Assessment protocols, photographs, ultrasound, magnetic resonance imaging and questionnaires will be used. The treatment will take place 3 times a week for 50 minutes, and will consist of a combination of therapies such as Carboxitherapy using equipment from the Ibramed™ brand, model Aires™, phototherapy from the Ibramed™ brand, model Antares™, radiofrequency from the Ibramed® brand, the Neartek™ model and manual therapy, in addition, the volunteers will wear compressive shorts during treatment. A total of 15 sessions will be carried out and the reassessment will be carried out after the last session, with the repetition of all the exams mentioned and photos for analysis of the results.

Description:

1. INTRODUCTION

Cellulite affects about 85 to 98% of women of all races after the onset of puberty, suggesting a hormonal component in its pathogenesis. It is a condition that consists of an edematous infiltration of the connective tissue, followed by polymerization of the fundamental substance which, infiltrating into the fabrics, produces a consecutive fibrotic reaction. Then, cellulite occurs as a consequence of connective tissue edema and ground substance hyperpolymerization. Thus, it manifests itself in the form of nodules or plaques of varied extension and location, and may even present pain in the affected areas.

The occurrence of multiple factors in its etiology makes it difficult to choose only one type of therapy for its treatment. Thus, aiming at greater therapeutic efficiency, the association of therapies is studied. One of the methods that can be chosen is radiofrequency, whose main mechanisms of action are dermal heating and vasodilation. The thermal action triggers an inflammatory cascade and stimulates neocollagenesis, causing the dermis to thicken. Vasodilation, on the other hand, leads to hyperemia and lymphatic drainage in the fat tissue. The association of these mechanisms improves the appearance of the skin, bringing good results to aesthetic problems.

Another technology that can be applied in the treatment of cellulite is the use of phototherapy. Light Emitting Diodes (LEDs) are devices made up of solid semiconductors linked together and that generate light. They provide a reliable, high-power light source in narrow bands that evenly illuminate a surface. LED does not use ablative or thermal mechanism, but there is a photochemical effect, in which light is absorbed and exerts a chemical change, showing the ability to induce photobiological processes in cells. In addition, LEDs have the ability to combine wavelengths with an array of various sizes, thus stimulating a wider range of tissue types.

In addition to these technologies, manual lymphatic drainage is a standard therapeutic tool that has been extensively studied over the years, which uses massage with gentle compressions to stimulate the removal of excess lymph that may be present in cellulite. Linked to its application, the therapist can also choose to use compression of the treated region, playing an important role in additional

reduction, increasing the continuous pumping mechanism. Several studies prove the effectiveness of the therapies mentioned above in the treatment of EGF. However, its cause is multifactorial and it is not possible to isolate each of these factors, which together, contribute to the onset of the disorder, requiring the combination of different treatments to achieve maximum results. Thus, the purpose of this study will be to evaluate the Sanae Method for the treatment of cellulite, using a combination of therapies.

2. OBJECTIVES

Main objective:

● Evaluate the Sanae method for the treatment of Cellulite.

Specific objectives:

• Investigate whether there is an improvement in the appearance of the region affected by cellulite through photographic and term photographic images;

• Analyze whether there are clinical changes through PAFEG after using the Sanae method (combination of therapies);

• Check for possible changes in skin architecture through ultrasound and magnetic resonance imaging after using the Sanae method (combination of therapies);

• Check changes in the quality of life of patients with cellulite.

• Check the degree of "satisfaction of the treated individual" with the results of treatment with the Sanae method.

3. JUSTIFICATION

The scientific production has the objective of appropriating reality to better analyze it and, later, producing transformations regarding the discussion on the use of protocols with combined therapies to maximize the therapeutic effect in the treatment of cellulite. In addition to being a very relevant practical aspect, it is of importance for the academic environment, taking into account the changes caused by the pathophysiology of cellulite, in addition to its great impact on society.

Cellulitis is a pathology that preferentially affects women, with a multifactorial etiology, thus, carrying out a more detailed study of the combination of therapies can be beneficial for the development of a more efficient treatment protocol, ensuring more satisfactory aesthetic results.

4. MATERIALS AND METHODS

The participants, after selection, will be guided about the procedures to be performed and will sign the Free and Informed Consent Term (TCLE). They were then submitted to assessment using the PAFEG, validated by Meyer et al. (2005), which is a data collection instrument that allows evaluating the degree of cellulite and the levels of sensory alterations resulting from this condition, and later, the

CELLUQOL summary questionnaire, validated by Hexsel et al. (2011), to assess the quality of life of volunteers.

The registration of photos will be carried out in orthostatism and in posterior and lateral views (right and left). The camera used will be the same in all the photos and will be positioned on a tripod at a height of 66 cm from the floor, it will be placed at a distance of 55 cm from the volunteer, for better visualization and standardization of the photos. In the same position, photography with a thermographic camera will be carried out.

Subsequently, they will undergo an ultrasound examination of the affected region. The exam will be carried out with the volunteers positioned in the prone position, in the gluteal and posterior region of the thigh, in an area of 10 cm², which will be delimited by a mold made of rubber E.V.A. A high-frequency ultrasound device (12MHZ) model XG, Samsung brand will be used. The volunteers will also undergo an evaluation of magnetic resonance, which will investigate changes related to cellulite in the skin's architecture, as described in previous studies.

5. PROCEDURES

For the treatment, the volunteers will receive 15 sessions in total, being held 3 times a week, lasting 50 minutes. The treatment protocol was distributed as follows:

Session 1 - Manual therapy only Sessions 2 to 6 - Carboxytherapy and phototherapy or radiofrequency Session 7 - Manual therapy only Sessions 8 to 14 - Carboxytherapy and phototherapy or radiofrequency Session 15 - Manual therapy only

Volunteers will be instructed to wear compressive shorts during treatment. The interventions will be performed using Ibramed™ Carboxitherapy equipment, model Aires™, phototherapy equipment from Ibramed™, model Antares™, radiofrequency equipment from Ibramed™, model Neartek™ In the end, the volunteers will answer the adapted questionnaires from the analysis of patient satisfaction, Segot-chicq et al. (2007) and the Global Aesthetic Improvement Scale - GAIS, by Narins (2003), which is used to classify the response to treatments, allowing a comparative assessment at different times after the therapeutic intervention. The reassessment will be made after the last session, with the repetition of all the procedures mentioned and photos.

The volunteers will be seen in a dermatofunctional physical therapy treatment outpatient clinic adequately structured for the proposed study, containing an appropriate environmental refrigeration system and good hygiene and lighting conditions, in accordance with the standards of the local Health Surveillance, it will be at the physical therapy clinic, located at Av. Antônio Basílio - Lagoa Seca/ Natal-RN owned by Dr. Eneida Carreiro.

6. DATA ANALYSIS

The collected data will be organized in Excel tables, quantitative data will be submitted to statistical analysis. Statistical analysis will be performed using the Statistical Package for Social Sciences (SPSS) version 17.0 for Windows. First, the Kolmogorov-Smirnov(K-S) test was performed to verify the normality of the data. In inferential statistics, the Two-way ANOVA variance test with repeated measures will be used to verify differences between the groups before and after the interventions. Throughout the statistical analysis, a significance level of 5% and a confidence interval of 95% (95% CI) will be assigned. Qualitative data (descriptive analysis of ultrasound and magnetic resonance images) will be described based on medical reports.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 48
• Est. completion date: December 1, 2023
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years to 55 Years

Eligibility

Inclusion Criteria:

• female sex

• aged between 35 and 55 years old

• multiparous or nulliparous

• using or not contraceptives

• sedentary.

Exclusion Criteria:

• sensitivity disorder during treatment

• do not adapt to the research times and procedures

• abnormalities in blood clotting (coagulopathy)

• use anticoagulants

• polyneuropathies

• pregnant women

• primary malignant disease (tumors) in the treatment area.

Related Conditions & MeSH terms

• Cellulite

Intervention

Device:
• Sanae method with LED
Sanae method (combination of therapies): Manual therapy, Carboxytherapy, and phototherapy.
• Sanae method with Radiofrecuency
Sanae method (combination of therapies): Manual therapy, Carboxytherapy, and radiofrequency.

Locations

Country	Name	City	State
Brazil	Universidade Potiguar	Natal	Lagoa Nova

Sponsors (1)

Lead Sponsor	Collaborator
Quiropraxia y Equilibrio

Country where clinical trial is conducted

Brazil, 

References & Publications (8)

Atiyeh BS, Dibo SA. Nonsurgical nonablative treatment of aging skin: radiofrequency technologies between aggressive marketing and evidence-based efficacy. Aesthetic Plast Surg. 2009 May;33(3):283-94. doi: 10.1007/s00266-009-9361-9. Epub 2009 May 13. — View Citation

Avram MM. Cellulite: a review of its physiology and treatment. J Cosmet Laser Ther. 2004 Dec;6(4):181-5. doi: 10.1080/14764170410003057. — View Citation

Barolet D. Light-emitting diodes (LEDs) in dermatology. Semin Cutan Med Surg. 2008 Dec;27(4):227-38. doi: 10.1016/j.sder.2008.08.003. — View Citation

Narins RS, Brandt F, Leyden J, Lorenc ZP, Rubin M, Smith S. A randomized, double-blind, multicenter comparison of the efficacy and tolerability of Restylane versus Zyplast for the correction of nasolabial folds. Dermatol Surg. 2003 Jun;29(6):588-95. doi: — View Citation

Rossi AB, Vergnanini AL. Cellulite: a review. J Eur Acad Dermatol Venereol. 2000 Jul;14(4):251-62. doi: 10.1046/j.1468-3083.2000.00016.x. — View Citation

Segot-Chicq E, Compan-Zaouati D, Wolkenstein P, Consoli S, Rodary C, Delvigne V, Guillou V, Poli F. Development and validation of a questionnaire to evaluate how a cosmetic product for oily skin is able to improve well-being in women. J Eur Acad Dermatol — View Citation

Young VL, DiBernardo BE. Comparison of Cellulite Severity Scales and Imaging Methods. Aesthet Surg J. 2021 May 18;41(6):NP521-NP537. doi: 10.1093/asj/sjaa226. — View Citation

Zelickson BD, Kist D, Bernstein E, Brown DB, Ksenzenko S, Burns J, Kilmer S, Mehregan D, Pope K. Histological and ultrastructural evaluation of the effects of a radiofrequency-based nonablative dermal remodeling device: a pilot study. Arch Dermatol. 2004 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Degree of cellulite	Grade of skin lumpiness or skin surface dimpling often seen on the thighs, buttocks and abdomen. It is due to protrusion of subcutaneus fat into the dermis layer of skin.	5 weeks post intervention
Primary	Levels of sensory alterations	Absent or reduced sensitivity to cutaneous stimulation.	5 weeks post intervention
Secondary	Functionality	Degree of functionality in activities of daily living presented by people with cellulite (assessed with the CELLUQOL questionnaire).The CELLUQOL questionnaire that will be used in this research, published by Hexsel et al (2011) analyzes how much the cellulite affects the participants' quality of life. Between 22 and 44 points, cellulite does not affect quality of life, between 44 and 66 points, cellulite affects quality of life little, between 66 and 88 points, cellulite reasonably affects quality of life, between 88 and 110 points, cellulite greatly affects quality of life.	5 weeks post intervention