Clinical trial NCT02743403: Effects of TENS in Pain During Application of Carboxytherapy in Patients With Gynoid Lipodystrophy
Official title: Effects of Transcutaneous Electric Nerve Stimulation in Pain During Application of Carboxytherapy in Patients With Gynoid Lipodystrophy: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Lead sponsor: Universidade Cidade de Sao Paulo
Sponsor class: OTHER
First posted: 2016-04-19
Enrollment: 84
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The project aims to compare the use of carboxiterapia ( therapeutic administration of carbon dioxide) with the use of active TENS and placebo TENS using the VAS scale as a parameter. The therapy used was started in the 30s , with carbonated water baths, and , lately, is involved in the therapeutic arsenal of numerous diseases , Both for treatment of diseases when for aesthetic treatments , especially for the gynoid lipodystrophy. However, the therapy presents CO2 in clinical practice, limiting factors for its use , such as pain at the injection site , small bruises or welts due to several punctures and feeling of crepitus. To try to combat these " side effects " that can last up to 30 minutes, the TENS was used in order to determine whether the use of this electric current helps at improvement of discomfort.

Detailed description: The assessment and intervention will be carried out only by the researcher, which has physical therapy training and expertise in dermato-functional physiotherapy with clinical experience in 11 years, as well as fulfilling all the prerequisites required for the management of carboxytherapy, according the judgment 293 of 16 June 2012 the Federal Council of Physical Therapy and Occupational Therapy (COFFITO). Patients will be submitted for assessment and intervention once.

Assessments should contain demographic information of the participants by asking questions such as age, marital status, education and contact, lifestyle, gynecological history, surgical history, anthropometric measurements and physical inspection examination (Annex 3). Patients are advised not to make use of any medication for pain relief such as painkillers and anti-inflammatories, within 4 hours before the physiotherapy session. For physical examination, evaluations will be conducted in the standing position, with bathing suit, keeping the gluteal region with maximum visibility. The appraiser will inspect the bilateral gluteal region, to confirm the moderate degree of severity of the gynoid lipodystrophy, defined by the gynoid lipodystrophy severity scale, with the number of skin depressions (ND) in moderate amount, ND≥ 5-9 depressions, according CSS classification.

For the study, three groups will be divided: group A (active TENS + active Carboxytherapy), Y group (TENS placebo + active Carboxytherapy) and S (active - control Carboxytherapy). Group A (active TENS + active Carboxytherapy) will be submitted to the application of TENS during the application of Carboxytherapy, both linked. The Y group (TENS placebo + active Carboxytherapy) will be submitted to the application of Carboxytherapy and TENS with low-dose therapy. The group S (active - control Carboxytherapy) will be submitted to the application of Carboxytherapy and off TENS. Prior to the beginning of the study, both devices will be calibrated. The gluteal that receive the intervention will be defined by lot.

After drawing the group and laterality of the gluteal region that receive the intervention, will be marked by white pencil, the depressions of the skin with cellulite and the delimitation of the area, from the following lines: lateral line will have as midpoint the greater trochanter, where a vertical line will be drawn from the iliac crest to the lateral edge of the gluteal groove; top line will be drawn a horizontal line parallel to the gluteal groove, 4 cm below the posterior superior iliac spine to the vertical line drawn previously from the greater trochanter bottom line will be drawn a horizontal line delimiting the gluteal groove; the medial end of the gluteal groove to the vertical line drawn previously from the greater trochanter; medial line is delimited by anatomically intergluteal slot.

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.

Primary outcomes:
measure: Mesure and denouement
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Universidade Cidade de São Paulo
Study officials:
name: Richard E Liebano, PhD
role: STUDY_DIRECTOR
References: