NCT03859505

Photobiomodulation Therapy on Inflammatory Mediators on Low Back Pain

Effects of Photobiomodulation Therapy on Inflammatory Mediators in Patients With Chronic Non-specific Low Back Pain: a Randomized Placebo-controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Universidade Cidade de Sao Paulo · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Low Back Pain

Interventions

Type	Name	Description
DEVICE	Placebo PBMT	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.
DEVICE	Active PBMT	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.

Timeline

• Start date: 2019-03-18
• Primary completion: 2019-03-29
• Completion: 2019-03-29
• First posted: 2019-03-01
• Last updated: 2019-04-01

Locations

1 site across 1 country: Norway