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Open Access Study protocol

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

Carly de Faria Coelho3, Ernesto Cesar Pinto Leal-Junior123, Daniela Aparecida Biasotto-Gonzalez23, André Serra Bley3, Paulo de Tarso de Camillo de Carvalho123, Fabiano Politti23, Tabajara de Oliveira Gonzalez3, Adriano Rodrigues de Oliveira13, Marcelo Frigero13, Marilia Barbosa Santos Garcia2, Almir Vieira Dibai-Filho4 and Cid André Fidelis de Paula Gomes13*

Author Affiliations

1 Postgraduate Program in Biophotonics Applied to Health Sciences, Universidade Nove de Julho (UNINOVE), Av. Dr. Adolfo Pinto,109, Água Branca, 05001-100 São Paulo, SP, Brazil

2 Postgraduate Program in Rehabilitation Sciences, Universidade Nove de Julho (UNINOVE), Av. Dr. Adolfo Pinto,109, Água Branca, 05001-100 São Paulo, SP, Brazil

3 Department of Physical Therapy, Universidade Nove de Julho (UNINOVE), Av. Dr. Adolfo Pinto,109, Água Branca, 05001-100 São Paulo, SP, Brazil

4 Postgraduate Program in Rehabilitation and Functional Performance, University of São Paulo, Av. Bandeirantes, 3900, Curso de Fisioterapia, Monte Alegre, 14049-900 Ribeirão Preto, SP, Brazil

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Trials 2014, 15:221  doi:10.1186/1745-6215-15-221

Published: 11 June 2014

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.

Keywords:
Phototherapy; Osteoarthritis of the knee; Postural balance; Lower limb strength; Physical therapy modalities