- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02743403
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
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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São Paulo, Brazil
- Universidade Cidade de Sao Paulo
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: FACTORIAL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Neurodyn Portable TENS
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. |
Randomization and secret Allocation active TENS (GI / n = 27)
Other Names:
Randomization and secret Allocation placebo TENS (GII / n = 27)
Other Names:
Randomization and secret Allocation control group (CG / n = 27).
|
PLACEBO_COMPARATOR: Placebo TENS- Neurodyn Portable TENS
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. |
Randomization and secret Allocation active TENS (GI / n = 27)
Other Names:
Randomization and secret Allocation placebo TENS (GII / n = 27)
Other Names:
Randomization and secret Allocation control group (CG / n = 27).
|
NO_INTERVENTION: Control
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mesure and denouement
Time Frame: through study completion, an average of 1 year
|
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
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Richard E Liebano, PhD
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Carboxytherapy,TENS and pain
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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