Effectiveness of phototherapy incorporated into an exercise program for osteoarthritis of the knee: study protocol for a randomized controlled trial

Carly de Faria Coelho, Ernesto Cesar Pinto Leal-Junior, Daniela Aparecida Biasotto-Gonzalez, André Serra Bley, Paulo de Tarso de Camillo de Carvalho, Fabiano Politti, Tabajara de Oliveira Gonzalez, Adriano Rodrigues de Oliveira, Marcelo Frigero, Marilia Barbosa Santos Garcia, Almir Vieira Dibai-Filho, Cid André Fidelis de Paula Gomes, Carly de Faria Coelho, Ernesto Cesar Pinto Leal-Junior, Daniela Aparecida Biasotto-Gonzalez, André Serra Bley, Paulo de Tarso de Camillo de Carvalho, Fabiano Politti, Tabajara de Oliveira Gonzalez, Adriano Rodrigues de Oliveira, Marcelo Frigero, Marilia Barbosa Santos Garcia, Almir Vieira Dibai-Filho, Cid André Fidelis de Paula Gomes

Abstract

Background: Osteoarthritis is a chronic disease with a multifactor etiology involving changes in bone alignment, cartilage, and other structures necessary to joint stability. There is a need to investigate therapeutic resources that combine different wavelengths as well as different light sources (low-level laser therapy and light-emitting diode therapy) in the same apparatus for the treatment of osteoarthritis. The aim of the proposed study is to analyze the effect of the incorporation of phototherapy into a therapeutic exercise program for individuals with osteoarthritis of the knee.

Methods/design: A double-blind, controlled, randomized clinical trial will be conducted involving patients with osteoarthritis of the knee. Evaluations will be performed using functional questionnaires before and after the treatment protocols, in a reserved room with only the evaluator and participant present, and no time constraints placed on the answers or evaluations. The following functional tests will also be performed: stabilometry (balance assessment), dynamometry (muscle strength of gluteus medius and quadriceps), algometry (pain threshold), fleximeter (range of motion), timed up-and-go test (functional mobility), and the functional reach test. The participants will then be allocated to three groups through a randomization process using opaque envelopes: exercise program, exercise program + phototherapy, or exercise program + placebo phototherapy, all of which will last for eight weeks.

Discussion: The purpose of this randomized clinical trial is to analyze the effect of the incorporation of phototherapy into a therapeutic exercise program for osteoarthritis of the knee. The study will support the practice based on evidence to the use of phototherapy in individuals with a diagnosis of osteoarthritis of the knee. Data will be published after the study is completed.

Trial registration: The protocol for this study has been submitted to Clinical Trials, registration number NCT02102347, on 29 March 2014.

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