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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02743403
• Other study ID #: Carboxytherapy,TENS and pain
• Status: Completed
• Phase: N/A
• First received: March 28, 2016
• Last updated: May 1, 2017
• Start date: January 2016
• Est. completion date: June 2016

Study information

• Verified date: January 2016
• Source: Universidade Cidade de Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: June 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 44 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lipodystrophy
• Pain

Intervention

Device:
• Neurodyn Portable activeTENS, IBRAMED®
Randomization and secret Allocation active TENS (GI / n = 27)
• Neurodyn Portable placeboTENS, IBRAMED®
Randomization and secret Allocation placebo TENS (GII / n = 27)
• Carboxyderm S20-1C
Randomization and secret Allocation control group (CG / n = 27).

Locations

Country	Name	City	State
Brazil	Universidade Cidade de São Paulo	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Cidade de Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mesure and denouement	It 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.	through study completion, an average of 1 year