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Clinical Trial Protocol

Vibration Anesthesia During Carboxytherapy for Cellulite: A Study Protocol

ORCID Icon, ORCID Icon & ORCID Icon
Pages 401-408 | Received 09 Sep 2021, Accepted 03 Dec 2021, Published online: 10 Jan 2022
 

Abstract

Background: To date, there has been no investigation addressing the effects of vibration anesthesia during carboxytherapy. Aim: Investigate the analgesic effect of different vibratory devices during carboxytherapy for the treatment of cellulite. Materials & methods: A total of 78 women between 18 and 49 years of age with cellulite in the gluteal region will be randomly allocated to three groups: Group A (carboxytherapy and vibratory device A), Group B (carboxytherapy and vibratory device B) and control group. Pain intensity will be assessed using a numerical rating scale after each puncture. Expected outcome: Vibration anesthesia is expected to be effective at diminishing the pain intensity caused by carboxytherapy comparison with the control group, with no differences between the vibratory devices.

Trial registry: Brazilian Registry of Clinical Trials: ReBEC (RBR-8jcqy7c)

Lay abstract

Vibrating anesthesia involves applying vibrations to the skin to reduce discomfort and pain during injections. So far, we do not know much about the therapeutic action of vibrating anesthesia on pain associated with carboxytherapy, a cosmetic treatment that involves injecting carbon dioxide into the fatty layer just beneath the surface of the skin. This article describes a plan to investigate the effect of vibration devices on pain reduction during the application of carboxytherapy in the treatment of cellulite. A total of 78 women between 18 and 49 years old with cellulite in the gluteal region (around the buttocks) will participate in the study and will be divided into three study groups; two groups will receive carboxytherapy with two different vibrating devices, and the third group will receive carboxytherapy without vibrational anesthesia. Pain intensity will be assessed by asking participants to rate their pain using a numerical rating scale after each puncture of carboxytherapy. Vibrational anesthesia is expected to decrease pain caused by carboxytherapy compared with the control group, and it is expected that there will be no differences in pain intensity relief between the two vibrating devices.

Financial & competing interests disclosure

The authors acknowledge the Coordenação de Aperfeiçoamento de Pessoal de Nível Superior – Brasil (CAPES) for their support. 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 state that they have obtained appropriate institutional review board approval or will follow the principles outlined in the Declaration of Helsinki for all human or animal experimental investigations. In addition, for investigations involving human subjects, informed consent will be obtained from the participants involved.

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