None listed
Conditions
Brief summary
Background: Cellulite, which has high prevalence in women of post-puberty age, and largest settlement in the gluteal-femoral region, is currently, along with volume and body circumferences reduction, one of the most aesthetic disturbing phenomena in the female population in terms of society's prevailing standards of beauty. There has, however, been a paucity of relevant research on cellulite, and the most of the few existing studies used unvalidated evaluation tools. Given this context, we were motivated to investigate the effectiveness of a therapy, the capacitive radio-frequency diathermy (CRFD), often used nowadays, using validated instruments for the evaluation. Objectives: To determine the efficacy of CRFD in reducing buttock and posterior thigh cellulite and perimeters from these areas, and to verify its relationship with the reduction of body weight and body mass index. Methods: Desing: Randomised controlled trial. Sample: 54 lower limbs of 27 women (26.41 +/- 6.16 years), each patient, two limbs being assigned by simple random distribution one to each group. First group received local application of CRFD (30 minutes), the second received the same treatment followed by a supplementary whole-segment application of CRFD (20 minutes). Each leg received 20 sessions, twice a week, never on consecutive days. Variables: Overall Cellulite Severity Scale score, with values between 0 (best score) and 15 (worst score), and its five dimensions: number of evident depressions; depth of depressions; morphological appearance of skin surface alterations; grade of laxity, flaccidity or sagging skin; and classification scale originally described by Nurnberger and Muller. These five dimensions are each scored from 0 (best score) to 3 (worst score). Body circumferences measured at the upper edge of both iliac crests, at the most anterior point of the both anterior superior iliac spines, at the upper pole of the greater trochanter of both femurs, and at 15, 20, 30 and 40 cm. of the anterior superior iliac spine in a line linking it with the upper pole of the patella. Body Mass Index, Body which was calculated from the results obtained in the measurement of weight and height according to the formula: BMI = weight(kg)/height(m)2. Temperatures recorded: at the start and at the end of each session, when the subject experienced it as too hot, and when the subject experienced it as insufficiently warm. Quality of life in skin disease measured by the Skindex-29 (Spanish version) and the concern about body shape and body dissatisfaction measured with the Body Shape Questionnaire (Spanish version). Main results: A significance of p<0.01 was observed for all the primary outcomes in both groups, thereby demonstrating the effectiveness of both treatments; no significant differences were observed between groups(p>0.05).
Interventions
In this split leg study, the interventional lower limb received local monopolar capacitive diathermy by radiofrequency in static application, administered by a a physiotherapist with more than ten years of experience. The whole treatment consisted of 20 sessions, at the rate of two sessions weekly, never on consecutive days.
At the start of each session, the initial temperature was recorded by means an infrared thermometer, and the electrodes were placed in a coplanar position in order to caus
In this split leg study, the interventional lower limb received local monopolar capacitive diathermy by radiofrequency in static application, administered by a a physiotherapist with more than ten years of experience. The whole treatment consisted of 20 sessions, at the rate of two sessions weekly, never on consecutive days. At the start of each session, the initial temperature was recorded by means an infrared thermometer, and the electrodes were placed in a coplanar position in order to cause heating of superficial tissues (adipose, connective, and vascular). The passive electrode was placed transversal to the longitudinal axis of the lower limb on the middle third of the buttock. The active electrode was placed longitudinal to the axis on the outer face of the upper third of the thigh. The electrodes were held in place by 3 elastic straps for stability and uniform contact. After positioning the electrodes, intensity was raised to 60 dosage units (36 A/min). The sensation perceived by the subject always had to be one of comfortable warmth, which reflected moderate heating of the tissues, and hence the criterion for the dosage of the intensity was the warming sensation reported by the subject. When this sensation exceeded pleasant warmth, the intensity was reduced by 10 units (6 A/min), and when the subject became accustomed to the sensation and reported feeling less warmth than that necessary, the intensity was increased by 10 units. The temperature was monitored using an infrared thermometer with ISO-CAL-IR calibration certification. Measurements were made during each session at minutes 0, 5, 10, 15, and 20, and whenever the subject requested a change in the intensity. The target range for the temperature was from 40 to 42 Celsius degrees under the active electrode for at least 12 minutes. When the temperature exceeded 44 Celsius degrees, intensity was reduced by 10 dosage units in order to avoid cell damage, even when the subject had not requested such reduction. Each application lasted 30 minutes. At the end of each session, the temperature was recorded, and the intensity was noted to serve as the initial setting for the next session.
Sponsors
Maria de la Casa Almeida
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
Woman Age between 18 and 40 years. Cellulite grade I, II, III (Nurnberger & Muller classification) in buttocks and posterior thighs Constant dietary habits and physical activity during the study Accepting the terms and schedule of the experiment Giving informed consent for the use of the data for research purposes
Exclusion criteria
Pacemaker Epilepsy Pregnancy, breastfeeding, or post-partum in the last year Changes in menstrual cycle, menopause or peri-menopause Chronic illness, hormonal or coagulation disorder Cancer Inflammation, infection, or open wound in the treatment area Obesity, lipedema, significant edema or circulatory disorders Metal implants or intrauterine device Weight fluctuations of more than two kilos in the last 6 months Drinking more than two alcoholic drinks a day Drug treatment, in particular, anti-inflammatory, esthetic, cosmetic, or dietary, simultaneous with the study Treatment of the zones under study in the previous 12 months Surgery involving the zones under study
Outcome results
None listed