Electroanalgesia During a Carboxytherapy Procedure for Cellulite: A Study Protocol for a Randomized Controlled Trial

Abstract

The aim of the present study is to describe a study protocol to compare different types of analgesic electrical currents on pain intensity and sensory comfort during the application of carboxytherapy for the treatment of cellulite. Seventy five women with the presence of moderate and/or severe gluteal cellulite will be randomly allocated into three groups: carboxytherapy plus transcutaneous electrical nerve stimulation, carboxytherapy plus interferential current or carboxytherapy plus Aussie current. Pain intensity, which is the primary outcome, will be measured by a numeric rating scale (0–10). The secondary outcome is sensory comfort, which will be measured using the visual analogue scale (0–10).

Trial registration: Brazilian Clinical Trials Registry: ReBEC (RBR-6z82zb) www.ensaiosclinicos.gov.br/rg/RBR-6z82zb/

Keywords::

• carboxytherapy
• cellulite
• electrical stimulation
• electroanalgesia
• pain
• women’s health

Author contributions

AY Sadala and RE Liebano were responsible for conceiving and designing the study. RE Liebano is the study coordinator. AY Sadala and EPR da Silva are responsible for data collection. All authors have contributed to writing and approved this manuscript.

Financial & competing interests disclosure

’Coordenação de Aperfeiçoamento de Pessoal de Nível Superior - Brasil (CAPES) – Finance Code 001’. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Ethical conduct of research

The authors declare that they obtained the approval of the Research Ethics Committee of the Federal University of São Carlos (UFSCar), under protocol number CAAE: 16390719.0.0000.550. To participate in this research, volunteers must sign the items selected in the informed consent form.