Analysis Phototherapy and Radiofrecuency Added to a Physical Therapy Program for Treatment of Cellulite
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Degree of cellulite
研究概览
简要总结
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.
详细描述
- 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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •female sex
- •aged between 35 and 55 years old
- •multiparous or nulliparous
- •using or not contraceptives
- •sedentary.
排除标准
- •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.
研究组 & 干预措施
Sanae with LED
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.
干预措施: Sanae method with LED (Device)
Sanae with Radiofrecuency
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.
干预措施: Sanae method with Radiofrecuency (Device)
结局指标
主要结局
Degree of cellulite
时间窗: 5 weeks post intervention
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
时间窗: 5 weeks post intervention
Absent or reduced sensitivity to cutaneous stimulation.
次要结局
- Functionality(5 weeks post intervention)
研究者
Hernán Andrés de la Barra Ortiz
Professor
Quiropraxia y Equilibrio