Effects of Led Photobiomodulation Therapy
Condition: Photobiomodulation
Study type: Interventional

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.
    

Detailed description: 
      Localized adiposity or localized obesity is the hyperplasia or hypertrophy of adipocytes in
      specific areas such as the abdomen and flanks, its development is associated with the risk of
      metabolic diseases and psychosocial changes related to low self-esteem, since aesthetic
      appearance is considered an imposed standard of beauty nowadays.

      The proportion of obese individuals has increased at alarming levels around the world and to
      combat it, several therapeutic approaches are needed, such as personalized diets and physical
      activity plans, in order to balance consumption and energy expenditure, but despite these
      controls, several adjuvant features such as non-invasive modalities are also being proposed
      to reduce subcutaneous fatty tissue.

      Among these modalities are the technologies of shock waves, cryolipolysis, focused
      ultrasound, radiofrequency and the use of light sources with photobiomodulation therapy. The
      latter, in turn, has shown relevant results in the possible reduction of subcutaneous fatty
      tissue.

      The use of a light source as a therapeutic form is already millenary and nowadays it is
      widely used as a modality to promote wound healing, reduce pain and possible damage and
      inflammation of tissues with the characteristic of not presenting photothermal or
      photoacoustic effects, thus termed as photobiomodulation therapy (PBMT). It can be used by
      using non-ionizing light sources such as Low Intensity Laser Therapy (LLLT) or Light Emitting
      Diode Therapy (LED).

      The landmark of the use of PBMT in the possible reduction of subcutaneous fatty tissue
      emerged with the double-blind randomized placebo-controlled study by Jackson et al. in 2012.
      A total of 689 individuals participated in the study, subdivided into a placebo group and an
      LLLT group, all of whom were evaluated during the treatment, in order to verify the possible
      reduction in the circumference of the waist, hips and thighs. Participants received a total
      of six LLLT treatments over 2 weeks with baseline and post-procedure circumferential
      measurements recorded. The results showed a significant reduction (p<0.0001) in circumference
      at the waist, hips and thighs one week after treatment with LLLT.

      Following the same line of research Jankowski et al., and Elnaggar, also carried out
      photobiomodulation studies to reduce fatty tissue and show partially significant results. The
      justification for the result was the smaller sample of participants compared to the study by
      Jackson et al., , however these studies were not able to elucidate which form of therapeutic
      action on fatty tissue to promote its reduction.

      The mechanisms by which PBMT can affect fatty tissue are still controversial, and it is
      hypothesized that PBMT could induce micropores in the adipocyte membrane, which allow the
      release of intracellular lipids and place them outside the interstitial space or an
      alternative hypothesis is that PBMT stimulates mitochondria in adipocytes, which, in turn,
      increases adenosine triphosphate (ATP) synthesis with subsequent activation of cyclic
      adenosine monophosphate (cAMP), promoting lipolysis, and the third hypothesis is that it
      depends on of the dose applied in PBMT, this can even stimulate adipocyte cell apoptosis,
      that is, there is still no clear physiological basis for its mechanism.

      Another important PBMT fact for the reduction of fatty tissue observed in articles already
      published is the difference in the wavelengths used, and in some articles the
      photobiomodulation was carried out with the red wavelength 630nm and in others the infrared
      808 or 850nm. It is believed that each of them must reach different depths of the fatty
      tissue and thus favor its reduction, however, there is no standardization of the protocol.

      Given this scenario, this study aimed to verify the real mechanism of action of PBMT when
      used in association of the wavelengths, red (630nm) and infrared (850nm) in the subcutaneous
      fatty tissue, through a clinical study with histological and immunohistochemistry analysis
      with markers of lipolysis and apoptosis in the subcutaneous fatty tissue of obese
      individuals.
    

Intervention name(s): LLLT RED
Intervention type(s): Device
Intervention description(s): 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.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: 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.
Masking: None (Open Label)
Primary purpose: Treatment