Effects of Led Photobiomodulation Therapy

NCT05012514 | Completed

• 1 other identifier: LLLT
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• immunohistochemical evaluation

  immunohistochemical evaluation with caspase 3 antibody

  one month

• Histological evaluation

  Histological evaluation with Masson's trichrome dye

  one month

Study Arms (2)

Control- Without intervention

NO INTERVENTION

The participants have the right side of the abdomen as a control without inversion

LLLT- With intervention

ACTIVE COMPARATOR

The participants received the LED PBMT treatment with associated red and infrared wavelengths sequentially on the left side of the abdomen

Device: LLLT RED

Interventions

LLLT RED DEVICE

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.

LLLT- With intervention

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

Sponsors & Collaborators

• Indústria Brasileira Equipamentos Médicos - IBRAMED: lead

Study Sites (1)

Ibramed - Indústria Brasileira de Equipamentos Médicos

Amparo, São Paulo, 13901-080, Brazil

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: N/D
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 3, 2021
• First Posted: August 19, 2021
• Study Start: August 8, 2020
• Primary Completion: March 10, 2021
• Study Completion: August 1, 2021
• Last Updated: August 19, 2021

Record last verified: 2021-08

Locations

BR (1)