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Phototherapy and Radiofrecuency for Cellulite

Primary Purpose

Cellulite

Status
Suspended
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Sanae method with LED
Sanae method with Radiofrecuency
Sponsored by
Quiropraxia y Equilibrio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cellulite focused on measuring Cellulite, Carboxytherapy, Phototherapy, Radiofrequency, Manual Therapy.

Eligibility Criteria

35 Years - 55 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Universidade Potiguar

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Sanae with LED

Sanae with Radiofrecuency

Arm Description

Phototherapy is related to light emission as a form of treatment for tissue and skin conditions. Its action depends on the absorption of light by chromophores, organelles present in the dermis and epidermis that give rise to cellular responses according to the different chemical reactions caused by light. The term "LED" means light emitted by a diode, thus, when the diode is subjected to an electrical current, light emission occurs (photon). Its applicability occurs in various disorders such as acne, alopecia, localized adiposity, stretch marks, cellulite, pre and postoperative, dark circles, etc. And they can also enhance treatments by promoting drainage, hydration, whitening, and rejuvenation, among other benefits.

Radiofrequency (RF) is considered a non-invasive therapy that enables thermal modification in the connective tissue of the skin, through dermal heating and vasodilation. Upon reaching the tissue, the current encounters resistance, and heat is produced by converting it into thermal energy. In this way, the deep dermis undergoes controlled volumetric heating, while the epidermis is preserved through cooling systems. Thermal damage 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 expected physiological effects are increased circulatory and nutrient supply, improving tissue hydration and oxygenation, greater metabolic and enzymatic activity, accelerating the elimination of catabolites, lipolysis, and the contraction of connective tissue.

Outcomes

Primary Outcome Measures

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.
Levels of sensory alterations
Absent or reduced sensitivity to cutaneous stimulation.

Secondary Outcome Measures

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.

Full Information

First Posted
June 11, 2022
Last Updated
March 25, 2023
Sponsor
Quiropraxia y Equilibrio
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1. Study Identification

Unique Protocol Identification Number
NCT05441917
Brief Title
Phototherapy and Radiofrecuency for Cellulite
Official Title
Analysis Phototherapy and Radiofrecuency Added to a Physical Therapy Program for Treatment of Cellulite
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Suspended
Why Stopped
Dissolution of the research team
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Quiropraxia y Equilibrio

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed Description
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. 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. 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. 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. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cellulite
Keywords
Cellulite, Carboxytherapy, Phototherapy, Radiofrequency, Manual Therapy.

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sanae with LED
Arm Type
Experimental
Arm Description
Phototherapy is related to light emission as a form of treatment for tissue and skin conditions. Its action depends on the absorption of light by chromophores, organelles present in the dermis and epidermis that give rise to cellular responses according to the different chemical reactions caused by light. The term "LED" means light emitted by a diode, thus, when the diode is subjected to an electrical current, light emission occurs (photon). Its applicability occurs in various disorders such as acne, alopecia, localized adiposity, stretch marks, cellulite, pre and postoperative, dark circles, etc. And they can also enhance treatments by promoting drainage, hydration, whitening, and rejuvenation, among other benefits.
Arm Title
Sanae with Radiofrecuency
Arm Type
Placebo Comparator
Arm Description
Radiofrequency (RF) is considered a non-invasive therapy that enables thermal modification in the connective tissue of the skin, through dermal heating and vasodilation. Upon reaching the tissue, the current encounters resistance, and heat is produced by converting it into thermal energy. In this way, the deep dermis undergoes controlled volumetric heating, while the epidermis is preserved through cooling systems. Thermal damage 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 expected physiological effects are increased circulatory and nutrient supply, improving tissue hydration and oxygenation, greater metabolic and enzymatic activity, accelerating the elimination of catabolites, lipolysis, and the contraction of connective tissue.
Intervention Type
Device
Intervention Name(s)
Sanae method with LED
Intervention Description
Sanae method (combination of therapies): Manual therapy, Carboxytherapy, and phototherapy.
Intervention Type
Device
Intervention Name(s)
Sanae method with Radiofrecuency
Intervention Description
Sanae method (combination of therapies): Manual therapy, Carboxytherapy, and radiofrequency.
Primary Outcome Measure Information:
Title
Degree of cellulite
Description
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.
Time Frame
5 weeks post intervention
Title
Levels of sensory alterations
Description
Absent or reduced sensitivity to cutaneous stimulation.
Time Frame
5 weeks post intervention
Secondary Outcome Measure Information:
Title
Functionality
Description
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.
Time Frame
5 weeks post intervention

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Universidade Potiguar
City
Natal
State/Province
Lagoa Nova
ZIP/Postal Code
59056-000
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
16020201
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.
Results Reference
result
PubMed Identifier
12786700
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: 10.1046/j.1524-4725.2003.29150.x.
Results Reference
result
PubMed Identifier
11204512
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.
Results Reference
result
PubMed Identifier
17894702
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 Venereol. 2007 Oct;21(9):1181-6. doi: 10.1111/j.1468-3083.2007.02193.x.
Results Reference
result
PubMed Identifier
32785706
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.
Results Reference
result
PubMed Identifier
14967794
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 Feb;140(2):204-9. doi: 10.1001/archderm.140.2.204.
Results Reference
result
PubMed Identifier
19437070
Citation
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.
Results Reference
result
PubMed Identifier
19150294
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.
Results Reference
result

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Phototherapy and Radiofrecuency for Cellulite

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