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