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Effects of Led Photobiomodulation Therapy

NCT05012514 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2021-08-19

No results posted yet for this study

Summary

Background: Photobiomodulation therapy (PBMT) has become an adjuvant therapeutic possibility in body remodeling procedures. Although this modality emerged in 1960, there are still few studies that demonstrate the real mechanism of action and possible interaction with subcutaneous fatty tissue. Given this scenario, this study was proposed with the aim of evaluating the effects of PBMT to Light Emitting Diode (LED) associating the red (630 nm) and infrared (850 nm) wavelengths in the subcutaneous fatty tissue. Methods: This is a non-randomized controlled study of comparative intervention that evaluated a sample of subcutaneous fatty tissue from women with grade II obesity. The participants received the LED PBMT treatment with associated red and infrared wavelengths sequentially on the left side of the abdomen and the right side was considered as control, with the collection of biological material performed at the time of bariatric surgery. For histological and immunohistochemical evaluation, Caspase 3, Cleaved Caspase 3, CD68+, HSL and adipophilin markers were used.

Conditions

  • Photobiomodulation

Interventions

DEVICE

LLLT RED

Participants received seven sessions of PBMT LED twice a week, the last session being about twenty minutes before the surgical procedure of bariatric surgery. The therapy was performed on the left side of the abdominal region following the linea alba of all research participants and the right side was considered as control, for application they will receive eye protection, using goggles for safety, the abdomen of the participants will be cleaned by using a neutral cleansing soap. A cluster applicator was used using the parameters described in table 1. For therapy, the equipment Antares® was used, IBRAMED- Indústria Brasileira de Equipamentos Eletromédicos EIRELI \[EIRELI Brazilian Industry of Electromedical Equipment\], approved by Anvisa Nº 10360310037. Figure 1.

Sponsors & Collaborators

  • Indústria Brasileira Equipamentos Médicos - IBRAMED

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-08-08
Primary Completion
2021-03-10
Completion
2021-08-01

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05012514 on ClinicalTrials.gov