光疗法结合运动计划治疗膝骨关节炎的有效性：一项随机对照试验的研究方案

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

作者信息

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

机构信息

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.

出版信息

Trials. 2014 Jun 11;15:221. doi: 10.1186/1745-6215-15-221.

DOI:10.1186/1745-6215-15-221

PMID:24919587

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4229877/

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.

摘要

背景

骨关节炎是一种病因多因素的慢性疾病，涉及骨排列、软骨及其他对关节稳定性至关重要的结构的改变。有必要研究在同一设备中结合不同波长以及不同光源（低强度激光疗法和发光二极管疗法）来治疗骨关节炎的治疗资源。本拟议研究的目的是分析将光疗纳入膝骨关节炎患者治疗性运动计划的效果。

方法/设计：将对膝骨关节炎患者进行一项双盲、对照、随机临床试验。在治疗方案前后，在只有评估者和参与者在场的专用房间内，使用功能问卷进行评估，对答案或评估不设时间限制。还将进行以下功能测试：稳定测量法（平衡评估）、测力计测量法（臀中肌和股四头肌肌力）、痛觉测量法（疼痛阈值）、关节活动度测量仪测量法（活动范围）、计时起立行走测试（功能活动能力）和功能性伸展测试。然后，通过使用不透明信封的随机化过程将参与者分为三组：运动计划组、运动计划 + 光疗组或运动计划 + 安慰剂光疗组，所有组均持续八周。