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

Universidade Cidade de Sao Paulo1 site in 1 country18 target enrollmentMarch 18, 2019

ConditionsLow Back Pain

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Low Back Pain
Sponsor: Universidade Cidade de Sao Paulo
Enrollment: 18
Locations: 1
Primary Endpoint: Levels of prostaglandin E2 (PGE2)
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

March 18, 2019

End Date

March 29, 2019

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Universidade Cidade de Sao Paulo

Responsible Party

Principal Investigator

Shaiane da Silva Tomazoni

Postdoctoral fellow and visiting researcher

Universidade Cidade de Sao Paulo

Eligibility Criteria

Inclusion Criteria

•patients with chronic non-specific low back pain (defined as pain or discomfort between the costal margins and the inferior gluteal folds, with or without referred symptoms in the lower limbs, for at least 3 month);
•with a pain intensity of at least 3 points measured by a 0-10 points pain numerical rating scale;
•aged between 18 and 65 years;

Exclusion Criteria

•evidence of nerve root compromise (i.e. one or more of motor, reflex or sensation deficit);
•serious spinal pathology (such as fracture, tumor, inflammatory and infectious diseases);
•serious cardiovascular and metabolic diseases;
•previous back surgery;
•pregnancy.
•severe skin diseases (eg. skin cancer, erysipelas, severe eczema, severe dermatitis, severe psoriasis and severe hives lupus);