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Effects of TENS in Pain During Application of Carboxytherapy in Patients With Gynoid Lipodystrophy

Effects of Transcutaneous Electric Nerve Stimulation in Pain During Application of Carboxytherapy in Patients With Gynoid Lipodystrophy: Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02743403
Enrollment
84
Registered
2016-04-19
Start date
2016-01-31
Completion date
2016-06-30
Last updated
2017-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

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.

Interventions

DEVICENeurodyn Portable activeTENS, IBRAMED®

Randomization and secret Allocation active TENS (GI / n = 27)

DEVICENeurodyn Portable placeboTENS, IBRAMED®

Randomization and secret Allocation placebo TENS (GII / n = 27)

DEVICECarboxyderm S20-1C

Randomization and secret Allocation control group (CG / n = 27).

Sponsors

Universidade Cidade de Sao Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 44 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Mesure and denouementthrough study completion, an average of 1 yearIt will be used to assess pain intensity of the participants. This scale has 11 points, ranging from 0 to 10, where 0 is no pain and 10 worst pain imaginable. Pain intensity will be measured in three groups: Group A, Group B and Group C, where the patient will quantify their pain viewing a rule containing a scale of 0 to 10. The assessment of this parameter will be made verbally, in which the patient should report the intensity of your pain when you are getting each prick of carboxytherapy.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026