Photobiomodulation Therapy on Inflammatory Mediators on Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Low back pain (LBP) is ranked as one of the most prevalent health conditions. It is likely
      that some inflammatory mediators could be associated with pain and disability in these
      patients. Photobiomodulation therapy (PBMT) is a non-pharmacological therapy often used in
      patients with LBP that decrease release of inflammatory mediators and accelerate muscle
      repair in different muscle skeletal conditions, as mechanisms of action. The present research
      project aims to evaluate the effects of PBMT on systemic levels of inflammatory markers and
      levels of pain intensity in patients with chronic non-specific low back pain.
    

Detailed description: 
      This is a randomized, triple-blinded (therapist, assessor and patient), placebo-controlled
      trial, with voluntary patients with non-specific chronic low back pain.

      Eighteen patients will be randomly allocated to two treatment groups: Placebo or PBMT and one
      single session of treatment will be provided.

      The data will be collected by a blinded assessor and the outcomes of interest it will be
      levels of inflammatory markers and pain intensity and it will be collected at baseline and 15
      minutes after the single session of treatment.

      The statistical analysis will follow the intention-to-treat principles. The findings will be
      tested for their normality using the Shapiro-Wilk test. Parametric data will be expressed as
      mean and standard deviation and non-parametric data as median and respective upper and lower
      limits. Parametric data will be analyzed by two-way repeated measures analysis of variance
      (ANOVA; time versus experimental group) with post-hoc Bonferroni correction. Non-parametric
      data will be analyzed using the Friedman test and, secondarily, the Wilcoxon signed-rank
      test.
    

Intervention name(s): Placebo PBMT; Active PBMT
Intervention type(s): Device; Device
Intervention description(s): The PBMT treatments will be performed using the Multi Radiance Medical™ Super Pulsed Laser MR4™console (Solon, OH, USA), with the LS50 (emitter with an area of 20 cm2) and SE25 (emitter with an area of 4 cm2) cluster probes as emitters. Nine sites will be irradiated at patient's lumbar region: 3 central sites, using the SE25 (without any dose, 0 J); and 6 sites in the same direction, but laterally (both sides, 3 at a side), using the LS50 (without any dose, 0 J). Patients will be treated in a single session and they will receive a total dose of 0 J.; The PBMT treatments will be performed using the Multi Radiance Medical™ Super Pulsed Laser MR4™ console (Solon, OH, USA), with the LS50 (emitter with an area of 20 cm2) and SE25 (emitter with an area of 4 cm2) cluster probes as emitters. Nine sites will be irradiated at patient's lumbar region: 3 central sites, using the SE25 (3000 Hz of frequency, 3 minutes of irradiation per site, 24.75 J per site, a totalizing 74.25 J irradiated from SE25); and 6 sites in the same direction, but laterally (both sides, 3 at a side), using the LS50 (1000 Hz of frequency, 3 minutes of irradiation per site, 24.30 J per site, a total of 145.80 J irradiated from LS50). Patients will be treated in a single session and will receive a total dose of 220.05 J.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Low Back Pain; Photobiomodulation Therapy; PBMT; Low-Level Laser Therapy; LLLT