Effects of TENS in Pain During Application of Carboxytherapy in Patients With Gynoid Lipodystrophy
Condition: Pain
MeSH terms: Lipodystrophy
Study type: Interventional

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.
    

Intervention name(s): Neurodyn Portable activeTENS, IBRAMED®; Neurodyn Portable placeboTENS, IBRAMED®; Carboxyderm S20-1C
Intervention type(s): Device; Device; Device
Intervention description(s): Randomization and secret Allocation active TENS (GI / n = 27); Randomization and secret Allocation placebo TENS (GII / n = 27); Randomization and secret Allocation control group (CG / n = 27).
Other intervention name(s): Carboxyderm S20-1C; Carboxyderm S20-1C
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment