Effects of TENS in Pain During Application of Carboxytherapy in Patients With Gynoid Lipodystrophy
Pain
About this trial
This is an interventional treatment trial for Pain
Eligibility Criteria
Inclusion Criteria:
- Body mass index < 18,5 a 29,9 kg/m²
- with regular menstrual cycle
- without prior experience with carboxytherapy and TENS
- with the presence of moderate gynoid lipodystrophy at gluteal region as classification Hexsel Dal'Forno & Hexsel (CSS )
Exclusion Criteria:
- pregnant women;
- nursing mothers;
- women with metabolic disorders and autoimmune diseases;
- which are suffering from skin lesions in the gluteal region and who have undergone surgical procedures in gluteus;
- the presence of malignant or benign tumor;
- with metal or silicone implants;
- heart disease and / or use of pacemakers, hypoesthesia or anesthesia in the gluteal region;
- women who have the risk of presenting epilepsy.
Sites / Locations
- Universidade Cidade de São Paulo
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Placebo Comparator
No Intervention
Neurodyn Portable TENS
Placebo TENS- Neurodyn Portable TENS
Control
Subjects in this study arm will receive active treatment. The active TENS device will be Neurodyn Portable TENS the IBRAMED® and application of carboxytherapy device will be Carboxyderm S20-1C equipment, Tone Derm® brand. The subject receives both devices at the same time. The parameters of the active TENS are: frequency (f) of 100 Hertz (Hz) oscillator every 0.5 seconds pulse duration (T) 200 microseconds (microsiemens) and the amplitude (I) will be adjusted at the time of application the carboxiterapia. The application of Carboxytherapy is realized by a carboxy Derm S20-1C equipment Derm® mark, which uses carbon dioxide (CO2) medical and non-toxic. Each prick with a needle carboxiterapia will 100ml / min and will last 1 minute long. Before each puncture will be adjusted to the intensity of TENS as sensitivity of the subject.
Subjects in this study arm will receive placebo treatment. The placebo TENS device will be Neurodyn Portable TENS the IBRAMED® and application of carboxytherapy device will be Carboxyderm S20-1C equipment, Tone Derm® brand. The application of placebo TENS will be made by the same unit of active TENS; however, it is used a device specially developed for this study. The device remains active only during the first 30 seconds of application. After this time, the current amplitude will gradually decrease over the next 15 seconds until it reaches zero, thereby interrupting the emission of electrical power to the remainder of the application time. The display of placebo TENS device shows a light on all the time of application, indicating the patient that the device is active.
Subjects in this study arm only receive the application carboxiterapia through Carboxyderm S20-1C equipment, Tone Derm® brand. The group (active - control Carboxytherapy) will be submitted to the application of Carboxytherapy and off TENS.