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

NCT02743403 | Completed DMC

• 1 other identifier: Carboxytherapy,TENS and pain
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Neurodyn Portable TENS

ACTIVE COMPARATOR

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.

Device: Neurodyn Portable activeTENS, IBRAMED®; Device: Neurodyn Portable placeboTENS, IBRAMED®; Device: Carboxyderm S20-1C

Placebo TENS- Neurodyn Portable TENS

PLACEBO COMPARATOR

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.

Device: Neurodyn Portable activeTENS, IBRAMED®; Device: Neurodyn Portable placeboTENS, IBRAMED®; Device: Carboxyderm S20-1C

Control

NO INTERVENTION

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.

Interventions

Neurodyn Portable activeTENS, IBRAMED® DEVICE

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

Also known as: Carboxyderm S20-1C

Neurodyn Portable TENS; Placebo TENS- Neurodyn Portable TENS

Neurodyn Portable placeboTENS, IBRAMED® DEVICE

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

Also known as: Carboxyderm S20-1C

Neurodyn Portable TENS; Placebo TENS- Neurodyn Portable TENS

Carboxyderm S20-1C DEVICE

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

Neurodyn Portable TENS; Placebo TENS- Neurodyn Portable TENS

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 )

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Cidade de Sao Paulo: lead

Study Sites (1)

Universidade Cidade de São Paulo

São Paulo, Brazil

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Richard E Liebano, PhD

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Researcher

Study Record Dates

• First Submitted: March 28, 2016
• First Posted: April 19, 2016
• Study Start: January 1, 2016
• Primary Completion: April 1, 2016
• Study Completion: June 1, 2016
• Last Updated: May 4, 2017

Record last verified: 2016-01

Data Sharing

• IPD Sharing: Will share

Locations

BR (1)