PATRÍCIA DO ARMO ILVA ARREIRA

PATRÍCIA DO CARMO SILVA PARREIRA

Eficácia do uso do Kinesio Taping em pacientes com condições musculoesqueléticas: uma revisão sistemática e um ensaio controlado

aleatorizado

UNIVERSIDADE CIDADE DE SÃO PAULO

SÃO PAULO

2013

PATRÍCIA DO CARMO SILVA PARREIRA

Eficácia do uso do Kinesio Taping em pacientes com condições musculoesqueléticas: uma revisão sistemática e um ensaio controlado

aleatorizado

Dissertação apresentada ao Programa de Mestrado em Fisioterapia da Universidade Cidade de São Paulo, como requisito para obtenção do título de Mestre, sob orientação do Prof. Dr. Leonardo Oliveira Pena Costa e co-orientação da Prof.a Dr.aLucíola da Cunha Menezes Costa

UNIVERSIDADE CIDADE DE SÃO PAULO

SÃO PAULO

2013

Banca Examinadora

Prof. Dr. Leonardo Oliveira Pena Costa ___________________________

Universidade Cidade de São Paulo

Prof. Dr. Richard Eloin Liebano __________________________________

Universidade Cidade de São Paulo

Prof. Dra Anamaria Siriani de Oliveira _____________________________

Universidade de São Paulo

DEDICATÓRIA

Dedico esta dissertação aos meus pais, José Lourenço Parreira e Nilze Silva Parreira.

Exemplos de dedicação, amor e apoio incondicional. Vocês são a base inabalável que

me sustenta para lutar pelos meus sonhos. Sem vocês esta vitória não teria sentido.

AGRADECIMENTOS

Agradeço a Deus por ter me dado paciência e perseverança na espera que um dia este

sonho se realizasse.

À minha família, meus irmãos Luiz Eduardo, Ana Paula e Luiz Fernando; meus

cunhados Priscila e Wilson; e meus adorados sobrinhos Eduardo, Pedro, Gabriel,

Bárbara e Giovana. Pela torcida incansável e por acreditarem em mim nos momentos

em que eu mesma duvidei. Amo vocês com todo o meu coração.

Não tenho palavras para agradecer ao meu orientador, muitas vezes anjo da guarda,

Professor Dr. Leonardo Oliveira Pena Costa por não ter medido esforços para me

ajudar. Agradeço por tudo que me ensinou sempre com tanta paciência e por

transformar meus sonhos mais ambiciosos em realidade. Com certeza uma das melhores

pessoas que Deus colocou na minha vida. Muito obrigada!

Agradeço também à minha co-orientadora Professora. Dra Lucíola da Cunha Menezes

Costa, minha fada madrinha. Agradeço a sua orientação realizada com tanto carinho,

paciência em todos os momentos cruciais neste percurso. Sua amizade foi um dos

maiores presentes neste mestrado.

Aos meus “irmãos” do grupo de estudos de dor lombar Tatiane Mota, Maurício Luz,

Luiz Carlos Hespanhol e Alessandra Narciso. Agradeço pelas opiniões, sugestões e

críticas e principalmente amizade em todos os momentos.

As minhas amigas Cecilia Matos, Wanda Machado, Paula Marreiros e Simone Dal

Corso pelas palavras de incentivo e companheirismo. Vocês são as melhores!

À Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP) e ao Conselho

Nacional de Desenvolvimento Científico e Tecnológico (CNPq), pelo apoio e

financiamento do estudo.

SUMÁRIO

Páginas

Sumário......................................................................................................................... vii

Prefácio........................................................................................................................... ix

Resumo........................................................................................................................... xi

Abstract........................................................................................................................ xiv

Capítulo 1: Contextualização........................................................................................ 1

1.1 Objetivos da dissertação................................................................................. 7

1.2 Referências...................................................................................................... 9

Capítulo 2: Current evidence does not support the use of Kinesio Taping in clinical

practice: a systematic review ………………………………………………………...14

Abstract............................................................................................................... 17

Introduction........................................................................................................ 18

Methods.............................................................................................................. 19

Results................................................................................................................. 23

Discussion........................................................................................................... 56

References........................................................................................................... 58

Capítulo 3: Do convolutions in Kinesio Taping matter? Comparison of two Kinesio

Taping approaches in patients with chronic non-specific low back pain: protocol of

a randomised trial......................................................................................................... 54

Abstract............................................................................................................... 55

Introduction......................................................................................................... 57

Methods/Design.................................................................................................. 58

Procedure……………………………................................................................ 64

Discussion………............................................................................................... 65

References........................................................................................................... 66

vii

Apêndice 1: Apostila de avaliação do estudo..................................................... 69

Capítulo 4: Convolutions generated by the use Kinesio Taping are not better than

placebo in patients with chronic non-specific low back pain: a randomised

controlled trial……....................................................................................................... 81

Abstract............................................................................................................... 84

Background......................................................................................................... 85

Methods.............................................................................................................. 86

Results................................................................................................................ 95

Discussion......................................................................................................... 100

References......................................................................................................... 105

Capítulo 5: Considerações Finais.............................................................................. 110

5.1 Resultados encontrados.............................................................................. 111

5.2 Pontos fortes e limitações do estudo.......................................................... 113

5.3 Implicações clínicas.................................................................................... 113

5.4 Sugestões para novos estudos.................................................................... 114

4.4 Referências................................................................................................. 115

Anexo 1: Instruções para os autores – Journal of Physiotherapy......................... 117

Anexo 2: Aprovação do Comitê de Ética e Pesquisa e Registro do estudo............ 121

viii

PREFÁCIO

Essa dissertação de mestrado aborda tópicos relacionados ao Kinesio Taping;

especificamente sobre eficácia do uso do Kinesio Taping em pacientes com condições

musculoesqueléticas, além de comparar os efeitos da aplicação de duas formas distintas

do Kinesio Taping (com circunvoluções e sem circunvoluções) em pacientes com dor

lombar crônica não específica para os desfechos intensidade da dor, incapacidade e

percepção do efeito global. É constituída por quatro capítulos, sendo que cada um deles

possui sua própria lista de referências bibliográficas. O Programa de Mestrado e

Doutorado em Fisioterapia da Universidade Cidade de São Paulo (UNICID) permite a

inclusão de artigos publicados, aceitos ou submetidos para publicação em seu formato

de publicação ou submissão no corpo do exemplar da dissertação.

O capítulo 1 apresenta uma contextualização de tópicos relevantes a respeito da dor

lombar, como definição, prevalência, custos, classificação, prognóstico e principais

intervenções utilizadas para tratar essa condição. Nesse mesmo capítulo estão

apresentados o método Kinesio Taping e os objetivos da dissertação. O capítulo 2 tem

como objetivo revisar sistematicamente as evidências atuais sobre a eficácia do Método

Kinesio Taping para pacientes com condições musculoesqueléticas. Este capítulo está

apresentado no formato exigido pelo Journal of Physiotherapy, ao qual está submetido

para publicação, exceto para figuras, quadros e tabelas, que estão localizados no corpo

do texto para facilitar a leitura pelos membros da banca examinadora. O capítulo 3

consiste no projeto de pesquisa do ensaio controlado aleatorizado que apresenta em

maiores detalhes os métodos desse estudo. Este capítulo está apresentado no formato de

artigo no periódico Journal of Physiotherapy, em que o referido projeto foi publicado.

No apêndice 1 está anexada a apostila de avaliação utilizada no estudo.

ix

O capítulo 4 tem como objetivo apresentar os resultados do estudo controlado

aleatorizado. Este capítulo está formatado nas normas da revista Journal of

Physiotherapy na qual o artigo está em processo de revisão. O capítulo 5 apresenta as

considerações finais da dissertação, bem como as implicações dos resultados para a

prática clínica e para a pesquisa e sugestões de estudos futuros sobre o tópico.

O estudo controlado aleatorizado dessa dissertação foi aprovado pelo Comitê de Ética

em Pesquisa da Universidade Cidade de São Paulo (PP13603502) e registrado

previamente ao início do estudo no Registro Brasileiro de Ensaios Clinicos (RBR-

7ggfkv). A revisão sistemática também foi registrada no International Prospective

Register of Systematic Reviews – PROSPERO (CRD42012003436).

x

RESUMO

Contextualização: O Kinesio Taping é uma técnica que utiliza uma fita elástica que

pode ser aplicada em diferentes níveis de tensão, gerando circunvoluções sobre a pele.

Segundo os criadores do método, a tensão aplicada, e consequentemente, a presença de

circunvoluções são fatores importantes para a eficácia do tratamento. Essas

circunvoluções promoveriam diversos efeitos fisiológicos entre eles diminuição dos

estímulos nociceptivos e alteração do padrão de recrutamento de fibras musculares

através de mecanismos de inibição neuromuscular. Apesar da grande utilização do

Kinesio Taping não existem estudos robustos que comprovem seus benefícios ou que

orientem o tratamento com este método em diferentes condições musculoesqueléticas.

Objetivos: Verificar através da realização de uma revisão sistemática se o Kinesio

Taping é mais eficaz do que nenhum tratamento, placebo ou outras intervenções em

pacientes com condições musculoesqueléticas para os desfechos intensidade da dor,

incapacidade, qualidade de vida e percepção do efeito global. Além de comparar,

através de um ensaio controlado aleatorizado, os efeitos da aplicação de duas formas

distintas do Kinesio Taping (com circunvoluções e sem circunvoluções) em pacientes

com dor lombar crônica não específica nos desfechos intensidade de dor, incapacidade e

percepção do efeito global.

Desenhos dos estudos: Foram realizados uma revisão sistemática e um estudo

controlado aleatorizado com dois braços, avaliador cego, registrado prospectivamente.

Método: Foram realizadas buscas sistematizadas nas bases de dados eletrônicas

MEDLINE, EMBASE, CENTRAL, PEDro, SPORTDiscus, CINAHL, LILACS e

SciELO. Foram extraídos os dados referentes aos desfechos intensidade da dor,

incapacidade, qualidade de vida e percepção do efeito global. A avaliação de risco de

xi

viés dos estudos incluídos nesta revisão sistemática foi realizada utilizando a escala

PEDro. A GRADE recommendations foi usada para classificar a qualidade da evidência.

Foram coletadas informações associadas com a qualidade metodológica e a

transparência das informações. Também foram testados os efeitos da aplicação de duas

formas distintas do Kinesio Taping em 148 pacientes em pacientes com dor lombar

crônica não específica nos desfechos intensidade de dor, incapacidade e percepção do

efeito global.

Resultados: Um total de 14 estudos controlados aleatorizados foram considerados

elegíveis (amostra total = 532 participantes). A eficácia do Kinesio Taping foi testada

em pacientes com diversas condições musculoesqueléticas. Em média, a qualidade

metodológica dos estudos elegíveis foi moderada (pontuação média de PEDro = 5,9

pontos em uma escala de 10 pontos). Como resultado o Método Kinesio Taping não se

mostrou melhor do que placebo ou grupos ativos. Em todas as comparações, em que o

Kinesio Taping foi melhor do que um grupo de controle ativo ou placebo, os tamanhos

de efeito foram pequenos e provavelmente clinicamente irrelevantes. No ensaio clínico

comparando as duas formas de aplicação do Kinesio Taping, não foram observadas

diferenças entre os grupos para os resultados primários da intensidade da dor (média das

diferenças = -0,4 pontos, IC 95% -1,3 a 0,4) e incapacidade (média das diferenças = -0,3

pontos, IC 95% -1,9 a 1,3). Houve uma pequena diferença em favor do grupo com

circunvoluções para o desfecho secundário percepção do efeito global (média das

diferenças = 1,4 pontos, IC 95% 0,3 a 2,5) em 4 semanas. Não foram observadas

diferenças entre os grupos para todos os demais desfechos secundários.

Conclusões: A evidência atual não suporta o uso dessa intervenção sobre as condições

musculoesqueleticas avaliadas. Em relação a dor lombar crônica, a aplicação do Kinesio

Taping segundo o método recomendado pelos criadores do mesmo, gerando

xii

circunvoluções na pele, não foi mais eficaz do que a simples aplicação de fita livre de

tensão para a redução da dor e incapacidade em pacientes com dor lombar crônica. A

teoria de circunvoluções na pele parece não ser válida para pacientes com dor lombar

crônica.

xiii

ABSTRACT

Background: Kinesio Taping is a method of treatment that is based upon the use of an

elastic adhesive tape that is applied to the patient’s skin under tension generating

convolutions. According to the creators of the method, the applied tension and the

presence of convolutions are considered key factors in order to obtain an effective

outcome. These convolutions promote various physiological effects including decreased

nociceptive stimuli and changes in the pattern of recruitment of muscle fibers through

the mechanisms of neuromuscular inhibition. Despite the widely use of Kinesio Taping

in clinical practice there are no robust studies demonstrating the benefits of this

intervention in patients with musculoskeletal conditions.

Objectives: To systematically review the effectiveness of Kinesio Taping compared

with no treatment, placebo or other interventions in patients with musculoskeletal

conditions on the outcomes pain intensity, disability, quality of life and global perceived

effect. The second objective was to compare the effectiveness of two different ways of

using the Kinesio Taping (with and without convolutions) in patients with chronic non-

specific low back pain on outcomes pain intensity, disability and global perceived

effect.

Study designs: Systematic review of randomised controlled trials and a prospectively

registered, assessor-blinded, two-arm randomized controlled trial.

Method: We performed systematic searches in the following electronic databases:

MEDLINE, EMBASE, CENTRAL, PEDro, SPORTDiscus, CINAHL, LILACS and

SciELO. We extracted data on the outcomes pain intensity, disability, quality of life and

global perceived effect. The assessment of risk of bias of the studies included in this

systematic review was performed using the PEDro scale. The GRADE approach was

xiv

used to classify the quality of the evidence. Finally we aslo collected information

associated with methodological quality and transparency of reporting. We also tested

the effects of applying two different ways of Kinesio Taping in 148 patients with

chronic non-specific low back pain on outcomes pain intensity, disability and global

perceived effect.

Results: A total of 14 randomized controlled trials were considered eligible (pooled

sample = 532 participants). The effectiveness of Kinesio Taping was tested on patients

with several musculoskeletal conditions. On average, the methodological quality of

eligible studies was moderate (average PEDro score = 5.9 points on a 10-point scale).

As a result the Kinesio Taping Method was not better than sham / placebo or active

groups. In all comparisons where Kinesio Taping was better than a group of active

control or placebo, the effect sizes were small and probably clinically irrelevant. In the

study comparing the effectiveness of two different ways of using the Kinesio Taping, no

between-group differences were observed for the primary outcomes of pain intensity

(mean difference= -0.4 points, 95% CI -1.3 to 0.4) and disability (mean difference= -0.3

points, 95% CI -1.9 to 1.3). There was a small difference in favor of the convolutions

group for the secondary outcome of global perceived effect (mean difference = 1.4

points, 95% CI 0.3 to 2.5) at 4 weeks. No between-group differences were observed for

all remaining secondary outcomes.

Conclusion: Current evidence does not support the use of this intervention in

musculoskeletal conditions evaluated. In relation to chronic low back pain, the

application of Kinesio Taping according the creators of the method was not more

effective than the simple application of tension-free tape for the reduction of pain and

disability in patients with chronic low back pain. These results challenge the proposed

mechanism of action of this therapy

xv

Capítulo 1

Contextualização

1

Contextualização

O Kinesio Taping foi criado por Kenso Kase (um quiropraxista japonês) nos

anos 70 e tornou-se um adjunto para tratamento para diversas condições clínicas ou

mesmo para melhora do desempenho de atletas nos últimos anos1. A técnica utiliza uma

fita elástica (comumente denominada como Kinesio Tex Gold® Tape) que pode ser

estendida em até 140% do seu tamanho original1. O terapeuta decide durante a avaliação

do paciente qual nível de tensão irá impor a bandagem, gerando circunvoluções sobre a

pele. Essas circunvoluções, segundo seus criadores1, 2, promoveriam uma elevação da

epiderme, diminuindo a pressão nos mecanoreceptores localizados abaixo da derme,

diminuindo assim os estímulos nociceptivos1. A técnica, segundo seus criadores1 teria

como benefícios melhorar a circulação sanguínea e linfática de tecidos, reduzir a dor e

realinhar as articulações1. Além disso, o uso do Kinesio Taping poderia alterar o padrão

de recrutamento de fibras musculares através de mecanismos de inibição e excitação

neuromuscular, efeitos esses já observados em alguns estudos3,

4. Contudo, até o

momento não foram realizados estudos de base que expliquem como a bandagem atue

fisiologicamente.

A teoria do Método Kinesio Taping tende a divergir das explicações fisiológicas

quanto funcionamento dos mecanoreceptores e nociptores. Esses receptores são regidos

pelo Princípio da Modalidade Específica5, em que cada receptor reage especificamente

a um tipo de estímulo. Dessa forma, um nociceptor não deveria responder a estímulos

mecânicos, como por exemplo, os proporcionados por uma bandagem elástica como a

utilizada pelo método Kinesio Taping5.

Outro aspecto relevante são as características fisiológicas dos receptores

localizados na pele5. Os mecanoreceptores detectam a deformação física do tecido onde

2

se localizam e são classificados como de baixa adaptação (continuam a disparar em

resposta a uma pressão constante sobre a pele) e de rápida adaptação (disparam em

resposta ao movimento da pele, mas não a uma pressão constante)5. Após a aplicação do

Kinesio Taping, as fibras de rápida adaptação são estimuladas, contudo esses receptores

tendem a se acomodar rapidamente. Do ponto de vista prático5, o paciente perceberá a

presença da bandagem logo após a sua colocação na pele, porém se acostumará ao

estímulo após algum tempo. Dessa forma, a fita poderia ter um efeito imediato, porém

não duradouro na redução da dor.

O uso do Kinesio Taping aumentou de forma drástica depois que quilômetros de

fitas foram doados para 58 delegações de países durante os Jogos Olímpicos de Pequim,

ocasionando um enorme interesse pelo uso da fita devido ao intenso marketing

divulgado na época6. Apesar da grande utilização do Kinesio Taping ainda não existem

estudos robustos que comprovem seus benefícios.

Foram publicadas diversas séries de casos7-17 e ensaios clínicos nas mais

diferentes condições de saúde18-23 utilizando o Kinesio Taping. Contudo parte desses

estudos foi conduzida com indivíduos normais e em atletas sem lesões24-32. Atualmente

existem cinco2,

25,

33-35 revisões sistemáticas sobre a utilização do Método Kinesio

Taping, com diferentes populações e desfechos. Uma25 delas avaliou a eficácia do

Kinesio Taping no tratamento e prevenção de lesões esportivas, duas2,

35 revisões avaliaram os efeitos terapêuticos do Kinesio Taping em diversas condições clínicas e

duas33, 34 revisões avaliaram os efeitos da Kinesio Taping em pacientes com condições

musculoesqueléticas. Contudo após a publicação destas revisões, muitos outros estudos

foram publicados36-40 e considerou-se que uma nova revisão sistemática com todos os

ensaios clínicos relevantes para pacientes com condições musculoesqueléticas seria

3

necessária para melhor informar a eficácia / efetividade desta intervenção. Os resultados

dessa revisão sistemática estão descritos no capítulo 2.

O uso do Kinesio Taping em casos de dor lombar vem aumentando

significativamente nos últimos anos, e surpreendentemente, não existem estudos que

recrutaram um contingente amostral significante ou que realizaram avaliações de médio

e longo prazo. Em uma busca realizada em diversas bases de dados foram encontrados

apenas dois estudos controlados aleatorizados que investigaram a eficácia do Kinesio

Taping em pacientes com dor lombar3, 4. O primeiro estudo4 avaliou a melhora da dor e

incapacidade comparando a aplicação de Kinesio Taping associado a exercícios, Kinesio

Taping utilizado de forma isolada e apenas exercícios. Os autores observaram redução

dos níveis de dor e incapacidade nos 3 grupos após quatro semanas, mas não

observaram diferenças entre os grupos. Contudo este estudo possui um grande número

vieses metodológicos, entre eles um reduzido poder estatístico, devido a uma amostra

de apenas 39 pacientes divididos em 3 grupos de 13 participantes em cada grupo, altas

perdas de seguimento e ausência de cegamento do avaliador. Esses vieses não permitem

uma melhor direção terapêutica para fisioterapeutas e pacientes. O segundo ensaio

clínico3 avaliou a melhora da dor, incapacidade, resistência muscular e cinesiofobia em

pacientes com dor lombar crônica. O grupo intervenção usou o Kinesio Taping e o

grupo controle uma falsa bandagem. Os pacientes permaneciam com as bandagens por

uma semana. O grupo intervenção foi discretamente superior ao controle para o

desfecho incapacidade após uma semana; porém após quatro semanas não foram

observadas diferenças entre os grupos para todos os demais desfechos. Apesar de ter

boa qualidade metodológica, o estudo possui um pequeno número de participantes

(n=60 divididos em 2 grupos de 30 participantes). Ambos os estudos só realizaram

apenas uma sessão de tratamento com a bandagem, o que talvez não reflita a prática

4

clínica e que talvez aplicações seriadas possam esclarecer mais sobre o uso do Kinesio

Taping em pacientes com dor lombar. Até o momento, nenhum estudo controlou os

possíveis efeitos adversos (alergia entre outros) com o uso dessa bandagem. Portanto

faz-se necessário que mais estudos com boa qualidade metodológica e maior

contingente amostral sejam conduzidos.

A dor lombar crônica é um grande problema a nível mundial e está associada a

enormes custos socioeconômicos e de saúde para a sociedade41, 42. A dor lombar pode

ser definida como dor ou desconforto localizado entre as margens costais e pregas

glúteas, com ou sem irradiação para os membros inferiores43. As estimativas de

prevalência de dor lombar variam consideravelmente nos estudos dependendo da

população investigada e definições de episódios de dor lombar. Segundo a mais recente

revisão sistemática44 sobre prevalência da dor lombar, a prevalência pontual equivale a

18%, nos últimos 30 dias corresponde a 31%, nos últimos 12 meses corresponde a 38%

e a prevalência em algum momento da vida foi estimada em 39%44. No Brasil, a

Pesquisa Nacional por Amostra de Domicílios (PNAD) apontou a dor nas costas como a

segunda condição de saúde mais prevalente, atrás apenas da hipertensão arterial

sistêmica45.

Nesse contexto de uma condição com alta prevalência, a dor lombar é

considerada como um importante problema de saúde pública em muitos países como os

Estados Unidos46, Austrália47 e países europeus43. Os custos associados com dor lombar

na Austrália superam 1 bilhão de dólares australianos47 enquanto nos Estados Unidos os

custos anuais associados a dor lombar superam a casa dos 50 bilhões de dólares

americanos46,

47 . Infelizmente não há dados sobre custos associados a dor lombar no Brasil. Independentemente das diferenças observadas nos custos dos sistemas de saúde

5

em diferentes países, não há dúvidas que a dor lombar representa um importante

problema econômico a nível mundial48.

A dor lombar pode ser classificada em três categorias42: 1) dor lombar não

específica, 2) doenças severas da coluna e 3) dor lombar com comprometimento de raiz

nervosa49. Os comprometimentos de raízes nervosas podem ser causados por prolapso

discal, estenose de canal lombar, ou ainda fibroses pós-cirúrgicas sendo que os

comprometimentos neurológicos podem ser identificados por um simples e cuidadoso

exame neurológico. As doenças severas da coluna incluem tumores, fraturas e doenças

infecciosas e inflamatórias como espondilite anquilosante, por exemplo. O restante dos

casos são classificados como não específicos. A maioria dos casos (cerca de 95%) de

dor lombar são da característica não específica, menos de 1% são devidos a doenças

graves de coluna e menos de 5% estão associados a comprometimento de raízes

nervosas49.

A dor lombar não específica é geralmente classificada em três estágios de acordo

com a duração dos sintomas (agudo, subagudo e crônico). Essa classificação é

extremamente importante para auxiliar profissionais de saúde para se determinar o

prognóstico, assim como proporcionar alternativas adequadas de tratamento para seus

pacientes49. Dor lombar aguda é usualmente definida como um episódio de dor que

persiste por menos de seis semanas, episódios com duração entre 6 a 12 semanas são

classificados como subagudos e episódios com duração superior a 12 semanas são

classificados como crônicos43.

A estimativa mais precisa e recente do prognóstico da dor lombar foi divulgada

em uma metanálise de estudos coorte prospectivos que analisou a evolução clínica da

dor e incapacidade em 11166 pacientes com dor lombar aguda e crônica50. Os autores

6

observaram que o prognóstico da dor lombar aguda inicialmente é favorável, com

redução da dor e incapacidade nas primeiras seis semanas. Após este período, ocorre

melhora dos sintomas mas em menor velocidade até um ano. Pessoas com dor lombar

crônica também apresentam melhora dos sintomas nas primeiras seis semanas, mas com

pouca melhora da dor e incapacidade no período entre 6 e 52 semanas.

Uma grande variedade de possibilidade terapêuticas estão disponíveis para

pacientes com dor lombar crônica41,

42 . Esses tratamentos variam de programas

educacionais51, passando por terapia cognitiva comportamental52, medicamentos53-55,

recursos eletrofísicos56 (crioterapia e termoterapia), terapia manual57, exercícios58 e

outros41. O Kinesio Taping é uma nova abordagem para tratamento da dor lombar, já

muito utilizado por atletas em diversos esportes. No caso de pacientes com dor lombar,

em que há grande atividade da musculatura paravertebral em resposta a dor; espera-se

que o uso de bandagens (como o Kinesio Taping) possa inibir essa atividade excessiva,

o que por sua vez pode aumentar a amplitude de movimento e por consequência a

funcionalidade dos pacientes, assim como diminuir os níveis de dor1.

O Manual do Método Kinesio Taping preconiza que a tensão aplicada e

consequentemente a presença de circunvoluções são fatores importantes para a eficácia

do tratamento1, 59 nas técnicas que visam melhorar o quadro de dor1. Contudo, até o

momento, nenhum estudo controlado aleatorizado de alta qualidade metodológica em

larga escala foi realizado para verificar os efeitos de diferentes tensões em pacientes

com dor lombar crônica.

Objetivos da dissertação:

Verificar através da realização de uma revisão sistemática se Kinesio Taping é

mais eficaz do que nenhum tratamento, placebo ou outras intervenções em

7

pacientes com condições musculoesqueléticas para os desfechos intensidade da

dor, incapacidade, qualidade de vida e percepção do efeito global.

Comparar, num estudo controlado aleatorizado, os efeitos da aplicação de duas

formas distintas do Kinesio Taping (com e sem circunvoluções) em pacientes

com dor lombar crônica não específica para os desfechos intensidade de dor,

incapacidade e percepção do efeito global.

8

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2. Morris D, Jones D, Ryan H, Ryan CG. The clinical effects of Kinesio Tex taping: A systematic review. Physiotherapy Theory and Practice. 2012;29(4):259-70. Epub 2012/10/24.

3. Castro-Sanchez AM, Lara-Palomo IC, Mataran-Penarrocha GA, Fernandez- Sanchez M, Sanchez-Labraca N, Arroyo-Morales M. Kinesio Taping reduces disability and pain slightly in chronic non-specific low back pain: a randomised trial. Journal of Physiotherapy. 2012;58(2):89-95. Epub 2012/05/23.

4. Paoloni M, Bernetti A, Fratocchi G, Mangone M, Parrinello L, Del Pilar Cooper M, et al. Kinesio Taping applied to lumbar muscles influences clinical and electromyographic characteristics in chronic low back pain patients. European Journal of Physical and Rehabilitation Medicine. 2011;47(2):237-44.

5. Kandel E, Schwarts J, Jessell T, Siegelbaum S, Hudspeth AJ. Principles of Neural Science: Mc Graw Hill; 2013.

6. The New York Times. A Quirky Athletic Tape Gets Its Olympic Moment. 2008; Available from: http://well.blogs.nytimes.com/2008/08/19/a-quirky-athletic-tape-gets- its-olympic-moment/?_r=0.

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8. Kaya E, Zinnuroglu M, Tugcu I. Kinesio taping compared to physical therapy modalities for the treatment of shoulder impingement syndrome. Clinical Rheumatology. 2011;30(2):201-7. Epub 2010/05/06.

9. Cortesi M, Cattaneo D, Jonsdottir J. Effect of kinesio taping on standing balance in subjects with multiple sclerosis: A pilot study. NeuroRehabilitation. 2011;28(4):365- 72. Epub 2011/07/05.

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11. Gonzalez-Iglesias J, Cleland JA, del Rosario Gutierrez-Vega M, Fernandez-de- las-Penas C. Multimodal management of lateral epicondylalgia in rock climbers: a prospective case series. Journal of Manipulative and Physiological Therapeutics. 2011;34(9):635-42. Epub 2011/10/25.

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9

13. Karatas N, Bicici S, Baltaci G, Caner H. The effect of Kinesiotape application on functional performance in surgeons who have musculo-skeletal pain after performing surgery. Turkish Neurosurgery. 2012;22(1):83-9. Epub 2012/01/26.

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17. Chang HY, Wang CH, Chou KY, Cheng SC. Could forearm Kinesio Taping improve strength, force sense, and pain in baseball pitchers with medial epicondylitis? Clinical Journal of Sport Medicine. 2012;22(4):327-33. Epub 2012/05/16.

18. Kalichman L, Vered E, Volchek L. Relieving symptoms of meralgia paresthetica using Kinesio taping: a pilot study. Archives of Physical Medicine and Rehabilitation. 2010;91(7):1137-9. Epub 2010/06/12.

19. Walsh SF. Treatment of a brachial plexus injury using kinesiotape and exercise. Physiotherapy Theory and Practice. 2010;26(7):490-6. Epub 2010/07/24.

20. Simsek TT, Turkucuoglu B, Cokal N, Ustunbas G, Simsek IE. The effects of Kinesio(R) taping on sitting posture, functional independence and gross motor function in children with cerebral palsy. Disability and Rehabilitation. 2011;33(21-22):2058-63. Epub 2011/03/16.

21. Stedge HL, Kroskie RM, Docherty CL. Kinesio taping and the circulation and endurance ratio of the gastrocnemius muscle. Journal of Athletic Training. 2012;47(6):635-42. Epub 2012/11/28.

22. Aguilar-Ferrandiz ME, Castro-Sanchez AM, Mataran-Penarrocha GA, Guisado- Barrilao R, Garcia-Rios MC, Moreno-Lorenzo C. A randomized controlled trial of a mixed Kinesio taping-compression technique on venous symptoms, pain, peripheral venous flow, clinical severity and overall health status in postmenopausal women with chronic venous insufficiency. Clinical Rehabilitation. 2013. Epub 2013/02/22.

23. Krajczy M, Bogacz K, Luniewski J, Szczegielniak J. The influence of Kinesio Taping on the effects of physiotherapy in patients after laparoscopic cholecystectomy. The Scientific World Journal. 2012;2012:948282. Epub 2012/05/31.

24. Chen CH, Huang TS, Chai HM, Jan MH, Lin JJ. Two stretching treatments for the hamstrings: proprioceptive neuromuscular facilitation versus kinesio taping. Journal of Sport Rehabilitation. 2013;22(1):59-66. Epub 2012/10/17.

10

25. Williams S, Whatman C, Hume PA, Sheerin K. Kinesio taping in treatment and prevention of sports injuries: a meta-analysis of the evidence for its effectiveness. Sports Medicine. 2012;42(2):153-64. Epub 2011/11/30.

26. Hoyo M, Alvarez-Mesa A, Sanudo B, Carrasco L, Dominguez S. Immediate effect of kinesio taping on muscle response in young elite soccer players. Journal of Sports and Rehabilitation. 2013;22(1):53-8. Epub 2012/09/26.

27. Lins CA, Neto FL, Amorim AB, Macedo Lde B, Brasileiro JS. Kinesio Taping((R)) does not alter neuromuscular performance of femoral quadriceps or lower limb function in healthy subjects: randomized, blind, controlled, clinical trial. Manual Therapy. 2013;18(1):41-5. Epub 2012/07/17.

28. Fratocchi G, Di Mattia F, Rossi R, Mangone M, Santilli V, Paoloni M. Influence of Kinesio Taping applied over biceps brachii on isokinetic elbow peak torque. A

placebo controlled study in a population of young healthy subjects. Journal of Science and Medicine in Sport / Sports Medicine Australia. 2013;16(3):245-9. Epub 2012/07/10.

29. Huang CY, Hsieh TH, Lu SC, Su FC. Effect of the Kinesio tape to muscle activity and vertical jump performance in healthy inactive people. Biomedical Engineering Online. 2011;10:70. Epub 2011/08/13.

30. Briem K, Eythorsdottir H, Magnusdottir RG, Palmarsson R, Runarsdottir T, Sveinsson T. Effects of kinesio tape compared with nonelastic sports tape and the untaped ankle during a sudden inversion perturbation in male athletes. The Journal of Orthopaedic and Sports Physical Therapy. 2011;41(5):328-35. Epub 2011/01/08.

31. Firth BL, Dingley P, Davies ER, Lewis JS, Alexander CM. The effect of kinesiotape on function, pain, and motoneuronal excitability in healthy people and people with Achilles tendinopathy. Clinical Journal of Sport Medicine. 2010;20(6):416- 21. Epub 2010/11/17.

32. Chang HY, Chou KY, Lin JJ, Lin CF, Wang CH. Immediate effect of forearm

Kinesio taping on maximal grip strength and force sense in healthy collegiate athletes. Physical Therapy in Sport. 2010;11(4):122-7. Epub 2010/11/09.

33. Mostafavifar M, Wertz J, Borchers J. A systematic review of the effectiveness of kinesio taping for musculoskeletal injury. Physician and Sports Medicine. 2012;40(4):33-40. Epub 2013/01/12.

34. Bassett K, Lingman S, Ellis R. The use and treatment efficacy of kinaesthetic taping for musculoskeletal conditions:a systematic review. New Zealand Journal of Physiotherapy. 2010;38(2):56-60.

35. Kalron A, Bar-Sela S. A systematic review of the effectiveness of Kinesio Taping(R) - Fact or fashion? European Journal of Physical and Rehabilitation Medicine. 2013. Epub 2013/04/06.

36. Campolo M, Babu J, Dmochowska K, Scariah S, Varughese J. A comparison of two taping techniques (kinesio and mcconnell) and their effect on anterior knee pain during functional activities. International Journal of Sports Physical Therapy. 2013;8(2):105-10. Epub 2013/04/18.

11

37. Llopis GL, Aranda CM. Physiotherapy intervention with kinesio taping in patients suffering chronic neck pain. A pilot study. Fisioterapia. 2012;34(5):189-95.

38. Djordjevic OC, Vukicevic D, Katunac L, Jovic S. Mobilization with movement and kinesiotaping compared with a supervised exercise program for painful shoulder: results of a clinical trial. Journal of Manipulative and Physiological Therapeutics 2012;35(6):454-63. Epub 2012/08/28.

39. Simsek HH, Balki S, Keklik SS, Ozturk H, Elden H. Does Kinesio taping in addition to exercise therapy improve the outcomes in subacromial impingement syndrome? A randomized, double-blind, controlled clinical trial. Acta Orthopaedica et Traumatologica Turcica journal. 2013;47(2):104-10. Epub 2013/04/27.

40. Saavedra-Hernandez M, Castro-Sanchez AM, Arroyo-Morales M, Cleland JA, Lara-Palomo IC, Fernandez-de-Las-Penas C. Short-term effects of kinesio taping versus cervical thrust manipulation in patients with mechanical neck pain: a randomized clinical trial. Journal of Orthopaedic & Sports Physical Therapy. 2012;42(8):724-30. Epub 2012/04/24.

41. van Tulder M, Becker A, Bekkering T, Breen A, del Real MT, Hutchinson A, et al. Chapter 3. European guidelines for the management of acute nonspecific low back pain in primary care. European Spine Journal. 2006;15 Suppl 2:S169-91. Epub 2006/03/22.

42. Chou R, Qaseem A, Snow V, Casey D, Cross JT, Jr., Shekelle P, et al. Diagnosis and treatment of low back pain: a joint clinical practice guideline from the American College of Physicians and the American Pain Society. Annals of Internal Medicine. 2007;147(7):478-91. Epub 2007/10/03.

43. Airaksinen O, Brox JI, Cedraschi C, Hildebrandt J, Klaber-Moffett J, Kovacs F, et al. Chapter 4. European guidelines for the management of chronic nonspecific low

back pain. European Spine Journal. 2006;15 Suppl 2:S192-300. Epub 2006/03/22.

44. Hoy D, Bain C, Williams G, March L, Brooks P, Blyth F, et al. A systematic review of the global prevalence of low back pain. Arthritis and Rheumatism. 2012;64(6):2028-37. Epub 2012/01/11.

45. Instituto Brasileiro de Geografia e Estatística (IBGE). Pesquisa Nacional por Amostra de Domicílios. Um Panorama da Saúde no Brasil: acesso e utilização dos serviços cdsef. 2008; Available from: http://bvsms.saude.gov.br/bvs/publicacoes/pnad_panorama_saude_brasil.pdf.

46. Deyo RA. Low-back pain. Scientific American. 1998;279(2):48-53. Epub 1998/07/23.

47. Walker BF, Muller R, Grant WD. Low back pain in Australian adults: the economic burden. Asia-Pacific Journal of Public Health. 2003;15(2):79-87. Epub 2004/03/25.

48. Dagenais S, Caro J, Haldeman S. A systematic review of low back pain cost of illness studies in the United States and internationally. The spine journal : official journal of the North American Spine Society. 2008;8(1):8-20. Epub 2008/01/01.

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49. Waddell G. The Back Pain Revolution: Churchill Livingstone; 2004.

50. Costa LC, Maher CG, Hancock MJ, McAuley JH, Herbert RD, Costa LO. The prognosis of acute and persistent low-back pain: a meta-analysis. Canadian Medical Association Journal. 2012;184(11):E613-24. Epub 2012/05/16.

51. Engers A, Jellema P, Wensing M, van der Windt DA, Grol R, van Tulder MW. Individual patient education for low back pain. Cochrane Database Systematic Review. 2008(1):CD004057. Epub 2008/02/07.

52. Ostelo RW, Deyo RA, Stratford P, Waddell G, Croft P, Von Korff M, et al. Interpreting change scores for pain and functional status in low back pain: towards international consensus regarding minimal important change. Spine (Phila Pa 1976). 2008;33(1)::90-4.

53. Gagnier JJ, van Tulder M, Berman B, Bombardier C. Herbal medicine for low

back pain. Cochrane Database of Systematic Review. 2006(2):CD004504. Epub 2006/04/21.

54. Deshpande A, Furlan A, Mailis-Gagnon A, Atlas S, Turk D. Opioids for chronic low-back pain. Cochrane Database of Systematic Review. 2007(3):CD004959. Epub 2007/07/20.

55. Roelofs PD, Deyo RA, Koes BW, Scholten RJ, van Tulder MW. Non-steroidal anti-inflammatory drugs for low back pain. Cochrane Database of Systematic Review. 2008(1):CD000396. Epub 2008/02/07.

56. French SD, Cameron M, Walker BF, Reggars JW, Esterman AJ. A Cochrane review of superficial heat or cold for low back pain. Spine (Phila Pa 1976). 2006;31(9):998-1006. Epub 2006/04/28.

57. Assendelft WJ, Morton SC, Yu EI, Suttorp MJ, Shekelle PG. Spinal manipulative therapy for low back pain. Cochrane Database of Systematic Review. 2004(1):CD000447. Epub 2004/02/20.

58. Hayden JA, van Tulder MW, Malmivaara A, Koes BW. Exercise therapy for treatment of non-specific low back pain. Cochrane Database of Systematic Review. 2005(3):CD000335. Epub 2005/07/22.

59. Parreira P, Costa Lda C, Takahashi R, Hespanhol Junior LC, Motta T, da Luz Junior MA, et al. Do convolutions in Kinesio Taping matter? Comparison of two Kinesio Taping approaches in patients with chronic non-specific low back pain: protocol of a randomised trial. Journal of Physiotherapy. 2013;59(1):52. Epub 2013/02/20.

13

Capítulo 2

Current evidence does not support the use of Kinesio Taping in clinical

practice: a systematic review

Kinesio Taping for musculoskeletal disorders Parreira Page 1 of 40

14

Correspondence (for review and publication):

Current evidence does not support the use of Kinesio Taping in clinical practice: a

systematic review

Authors: Patrícia do Carmo Silva Parreira1, Lucíola da Cunha Menezes Costa1, Luiz

Carlos Hespanhol Junior1, Alexandre Dias Lopes1, Leonardo Oliveira Pena Costa1,2

Affiliations: 1 Masters and Doctoral Programs in Physical Therapy, Universidade

Cidade de São Paulo, Brazil, 2 Musculoskeletal Division, The George Institute for

Global Health, Australia

Abbreviated title: Kinesio Taping: a systematic review

Keywords: kinesio taping; systematic review; musculoskeletal conditions

Word Count: Abstract: 241 (Introduction, Method, Results, Discussion): 3548

References: 32

Tables: 6

Figures: 2

Boxes: 1


15

Name Leonardo Oliveira Pena Costa

Department Masters and Doctoral Programs in Physical Therapy

Institution Universidade Cidade de São Paulo

Country Brazil

Tel +55 (11) 2178 1564

Mob +55(11) 98183 1550

Email [email protected]

ABSTRACT

Questions: Is Kinesio Taping more effective than a sham/placebo, no treatment or other

interventions in patients with musculoskeletal conditions? Is the addition of Kinesio

Taping to other interventions more effective than other interventions alone in patients

with musculoskeletal conditions? Design: Systematic review of randomised trials.

Participants: People with musculoskeletal conditions. Intervention: Kinesio Taping

was compared with placebo/sham, no treatment, exercises, manual therapy and

conventional physiotherapy. Outcome measures: Pain intensity, disability, quality of

life, return to work, and global impression of recovery. Results: Twelve randomised

trials involving 495 participants were included in the review. The effectiveness of the

Kinesio Taping was tested in patients with shoulder pain in 2 trials, knee pain in 3 trials,

chronic low back pain in 2 trials, neck pain in 3 trials, plantar fasciitis in 1 trial, and

multiple musculoskeletal conditions in 1 trial. The methodological quality of eligible

trials was moderate with a mean of 6.1 points on the 10-point PEDro Scale score.

Overall Kinesio Taping was not better than sham/placebo and active comparison

groups. In all comparisons where Kinesio Taping was better than an active or a sham

control group, the effect sizes were small and probably not clinically worthwhile or the

trials were of low quality. Conclusion: This review provides the most updated evidence

on the effectiveness of the Kinesio Taping in patients with musculoskeletal conditions.

The current evidence does not support the use of this intervention in these clinical

populations. PROSPERO registration: CRD42012003436


16

INTRODUCTION

Kinesio Taping has become a very popular treatment for several health conditions over

the last decade. This method of taping was created by a Japanese chiropractor in the

1970s (Kase et al 2003). Kinesio Taping uses elastic tape that is fixed on the skin of

patients. Kinesio Tape is thinner and more elastic than conventional tape, which is

hypothesized to allow greater mobility and skin traction (Callaghan and Selfe 2012,

Castro-Sanchez et al 2012). Kinesio Taping involves a combination of applying tension

along the tape and placing the target muscle in a stretched position so that convolutions

in the tape occur after the application (Kase et al 2003). During assessment of the

patient, the therapist decides what level of tension will generate an appropriate level of

traction on the skin. According to the Kinesio Taping Method Manual, this traction

promotes an elevation of the epidermis and reduces the pressure on mechanoreceptors

that are below the dermis, thus reducing the nociceptive stimuli (Kase et al 2003). Other

proposed benefits include improved blood and lymphatic circulation, reduced pain

intensity, realignment of joints and change in the recruitment activity patterns of the

treated muscles (Kase et al 2003). Although widely used in clinical practice by many

physiotherapists worldwide, there is little evidence about the efficacy or effectiveness of

this intervention (Castro-Sanchez et al 2012, González-Iglesias et al 2009, Thelen et al

2008).

Five systematic reviews have evaluated the effect of Kinesio Taping on selected

outcomes in different populations. Williams et al (2012) assessed Kinesio Taping in the

prevention and treatment of sports injuries only. Bassett et al (2010) and Mostafavifar et

al (2012) assessed the effects of Kinesio Taping in patients with musculoskeletal

conditions. Morris et al (2012) and Kalron and Bar-Sela (2013) widened the

musculoskeletal focus to other clinical areas, such as neurological and lymphatic

conditions. Currently, new trials of Kinesio Taping are being published frequently.

Therefore, although these five reviews were published recently, each of them did not

include at least one of the following trials: Campolo et al (2013), Castro-Sanchez et al

(2012), Llopis et al (2012), Saavedra-Hernandez et al (2012), and Simsek et al (2013).

Given this substantial amount of new data, an updated systematic review was needed to

inform clinicians and patients about the effects of this intervention in musculoskeletal

conditions. The research questions of this systematic review were: Kinesio Taping for musculoskeletal disorders Parreira Page 4 of 40

17

1. Is Kinesio Taping more effective than a no treatment or sham/placebo in patients

with musculoskeletal conditions for the outcomes pain intensity, disability,

quality of life, return to work and global impression of recovery?

2. Is Kinesio Taping more effective than other interventions in patients with

musculoskeletal conditions for these outcomes?

3. Is the addition of Kinesio Taping over other interventions more effective than

other interventions alone in patients with musculoskeletal conditions for these

outcomes?

METHOD

Identification and selection of studies

Systematic searches were conducted of MEDLINE, Embase, CENTRAL, PEDro,

SPORTDiscus, CINAHL, LILACS and SciELO. We accepted papers in any language if

a translation could be obtained. Our search strategies followed the recommendations of

the Cochrane Back Review Group (2012). Detailed search strategies used in each

database are described in Appendix 1. The date of the last search was 10 June 2013. We

also searched in all clinical trial registries and manual searches were performed by

checking the reference lists of each eligible article.

Studies were considered for inclusion if they met the criteria presented in Box 1.

Conference abstracts were excluded. We also excluded studies that were conducted on

healthy participants or that only collected outcomes related to physical performance (eg,

muscle strength, vertical jumping). Our primary outcomes were pain intensity and

disability measured by any validated outcome measure.


18

Box 1. Inclusion criteria Design randomised controlled trials published in a peer-reviewed journal

Participants people with musculoskeletal conditions

Intervention interventions using the Kinesio Taping Method

Outcomes measured pain intensity disability quality of life return to work global impression of recovery

The study selection process involved screening the titles and reading the abstracts, after

which potentially relevant articles were obtained in full text for further analysis

regarding eligibility. Two independent reviewers performed the selection of the studies

and, in the case of disagreement; a third reviewer obtained a consensus through

discussion or arbitration.

Data extraction was performed by two independent reviewers using a standardised data

extraction form. In the case of disagreement, consensus was obtained through

discussion or arbitration by a third reviewer. The following data were extracted: authors,

year of publication, musculoskeletal condition of the study participants, study

objectives, description of the sample, description of the Kinesio Taping Method

intervention, description of the control group (ie, placebo, no intervention or other

intervention), study outcomes, assessment times, study results and study conclusions.

When insufficient data were presented, the authors were contacted by email and

requested to provide the data.

Assessment of characteristics of studies

Quality: The methodological quality studies included in this systematic review were

assessed using the PEDro scale (Sherrington et al 2000). This scale assesses the risk of

bias and statistical reporting of randomised controlled trials. This scale has 11 items: 8

items relate to methodological quality (ie, random allocation, concealed allocation,


19

baseline comparability, blinded subjects, blinded therapists, blinded assessors, adequate

follow-up and intention-to-treat analysis) and 2 items related to the statistical reporting

(between-group comparisons, and point estimates and variability). The first item

(eligibility criteria) is not considered in the total score since it is related to external

validity. The total PEDro score ranges from 0 to 10 points and higher scores mean

greater methodological quality. This scale has good levels of validity and reliability

(Macedo et al 2012, Maher et al 2003, Shiwa et al 2011).

We also extracted data related to: trial registration, funding, sample size calculation, and

whether a primary outcome was nominated. These four items were selected from the

CONSORT statement and are associated with better transparency and methodological

quality (Geha et al 2013, Moher et al 2010).

Participants: Trials involving people with musculoskeletal conditions were considered

for inclusion. Age and sample size were used to characterise the groups of participants.

Intervention: The experimental intervention was the use of the Kinesio Taping method

for any musculoskeletal condition. The application procedure and the regimen of taping

applications (ie, duration, frequency of re-taping) were used to characterise the

interventions.

Outcomes measures: Data were extracted for the following outcomes: pain intensity,

disability, quality of life, return to work and global impression of recovery. To

summarise the effects of the intervention for continuous data, we extracted the mean

between-group difference and their respective 95% confidence intervals for each

outcome extracted. One study (Campolo, 2013) presented non-parametric data only.

The data from this study was converted to parametric data in order to calculate

confidence intervals following the recommendations of Hozo et al (2005). For studies

that did not present mean differences and confidence intervals, we calculated these

estimates by using the confidence interval calculator downloaded from the PEDro

website.


20

Data analysis

Due to the clinical heterogeneity of the studies included in this systematic review and

the variability between health conditions assessed by them, it was not possible to

perform a meta-analysis. Therefore, the data analysis was descriptive. For the primary

outcomes of pain intensity and disability, descriptive forest plots without pooling were

performed for better visualization. In all cases of multiple follow up points, we plotted

only the longest-term measurement point available. Disability scales were converted to

a common 0 to 100 scale. Forest plots were performed only for comparisons with two or

more studies. RevMan 5.1 was used for the analysis.

The overall quality of the evidence and the strength of recommendations were evaluated

using the GRADE approach (Guyatt et al 2011). The GRADE approach specifies four

levels of quality (high, moderate, low and very low). We downgraded the overall

evidence depending on the presence of five factors:

1. limitations (due to risk of bias),

2. consistency of results,

3. directness (eg, whether participants are similar to those about whom conclusions

are drawn),

4. precision (ie, sufficient data to produce narrow confidence intervals)

5. other (eg, publication bias).

The quality of evidence was then classified for each outcome according to the following

criteria.

High quality evidence: There are consistent findings among at least 75% of the

participants from low risk of bias studies, consistent, direct and precise data and no

known or suspected publication biases. Further research is unlikely to change either the

estimate or our confidence in the results.

Moderate quality evidence: One of the domains is not met. Further research is likely to

have an important impact on our confidence in the estimate of effect and may change

the estimate.


21

Low quality evidence: Two of the domains are not met. Further research is very likely

to have an important impact on our confidence in the estimate of effect and is likely to

change the estimate.

Very low quality evidence: Three of the domains are not met. We are very uncertain

about the results.

No evidence: No randomised trials were identified that addressed this outcome.

Single studies with a sample size smaller than the optimal information size (n = 300)

were considered to yield very low quality evidence if there was also a high risk of bias (

PEDro score < 6) or low quality evidence if there was a low risk of bias (PEDro score ≥

6). RESULTS

Flow of studies through the review

From the search strategy, 275 potentially relevant studies were retrieved. Of these, 12

studies were considered eligible for data analysis (Akbas et al 2011, Aytar et al 2011,

Campolo et al 2013, Castro-Sanchez et al 2012, Evermann 2008, González-Iglesias et al

2009, Llopis and Aranda 2012, Paoloni et al 2011, Saavedra-Hernandez et al 2012,

Simsek et al 2013, Thelen et al 2008, Tsai et al 2010). The flow of studies through the

selection process is presented in Figure 1.


22

Records identified through

database searching (n = 275)

Additional records identified through other sources

(n = 0)

Records after duplicates removed

(n = 192)

Titles screened (n = 192)

Abstracts screened (n = 83)

Full-text articles assessed for eligibility

(n = 28)

Studies included in qualitative synthesis

(n = 12)

Studies included in quantitative synthesis

(meta-analysis)

Records excluded (n = 109)

Records excluded

(n = 55)

Full-text articles excluded (n = 16)

participants without musculoskeletal conditions (n = 2)

participants were healthy (n = 9)

intervention was not exclusively Kinesio Taping (n = 3)

no relevant outcome data were reported (n = 2)

(n = 0)

Figure 1. Selection of studies for inclusion in the systematic review

Description of studies

The 12 eligible trials were published between 2008 and 2013. The sample sizes ranged

from 10 (Llopis and Aranda 2012) to 76 (Saavedra-Hernandez et al 2012) participants.

The pooled sample size was 495 patients, with a mean of 41 participants per study. A

description of all included studies is presented in Table 1.


23

Table1.Sum

maryofincludedstudies(n=

12)

Study

Akbas

2011

Population

n=31

patellofemoralpain

syndrome

Age(yr)=

exp41

(SD

11),con45(SD

8)

Aytar

2011

Cam

polo

2013

n=20(crossover)

unilateralanterior kneepain

Age(yr)=

24(SD

3)

Castro-

Sanchez

2012

n=59

chronicnon-specific

lowbackpain

Age(yr)=

exp50

(SD

15),con47(SD

13)

Insitting,4I-stripswereappliedat25%

tension

overlappinginastarshapeoverthepointofmaxim

umpain

inthelumbararea.S

tripswereappliedbypressingthe

centralpartbeforetheends.Thetapew

askeptinsitufor1

week.

KinesioTapingform

usculoskeletaldisorders P

arreira

Page11of40

n=22

patellofemoralpain

syndrome

Age(yr)=

24(SD

3)

KinesioTapinggroup

C

omparisongroup(s)

Individualisedtapingoverthevastusmedialisobliquus,

Con:usualcare.6-w

eekhome

quadriceps,vastuslateralis,iliotibialband/tensorfascialataprogramofstretchesofiliotibial

andhamstringm

uscles.Thetapew

aschangedevery4-5

band/tensorfascialatacomplex,

daysfor6weeks.U

sualcare(seeright)wasalsogiven.

hamstringandquadriceps

muscles;strengtheningof

quadriceps,hipadductorsand

gluteals;andopenandclosed

chainexercises. In45°kneeflexion,tw

oY-stripsw

ereappliedtothe

Con:sham

taping.Sticking

quadricepswiththetailsappliedaroundthepatellaandjust

plasterwasappliedinthesam

e below

thetibialtuberosity.TwoI-stripsw

ereapplied

configurationbutwithout

aroundthepatellawith50–75%

tension.Thetaperem

ainedstretch,andremainedinsitu

insituduringtestingonly. duringtestingonly.

Onestripw

asappliedovertherectusfemorism

usclefrom

McC

onnelltapingtechnique: theproxim

althirdofthethightothepatella.Atthepatella,

Strappingtapew

asapplied

thestripwasdividedintw

otogoaroundthepatellar acrossthepatellarregionand

borders.Thetaperem

ainedinsituduringtestingonly. rem

ainedinsituduringtesting

only.C

on:notape

Con:sham

taping.OneI-stripof

thesametapew

asapplied

transverselyacrossthepain.The

tapewaskeptinsitufor1w

eek.

24

Everm

an

n=65

n2008

musculoskeletal

conditionsa

Age(yr)=

exp23, con25

Gonzálezn=

41

-Iglesias neckpainw

ithout 2009

nerveconduction

loss A

ge(yr)=exp33

(SD

6),con32(SD

7)

Llopis

2012

n=10

mechanicalneck

pain

Age(yr)=

30(SD

12)

n=39

chroniclowback

pain

Age(yr)=

63(SD

12)

Paoloni

2011

Thetapew

asappliedeitheraswholestripsorhalved

lengthwiseandappliedasastarshape.Fourstripsoftape

about20cminlengthinastarshapew

ereappliedover painfultriggerpoints.D

urationoftheinterventionisnot stated.O

neY-stripw

asappliedsymm

etricallyovertheposterior cervicalextensorm

uscles,withpaper-offtensionandw

ith

cervicalcontralateralsidebendingandrotation.Thetape

wasappliedfrom

thedorsalregion(T1-T

2)totheupper cervicalregion(C

1-C2).A

noverlyingI-stripwasplaced

perpendiculartotheY-strip,overthem

idcervicalregion

(C3-C

6),withthepatient’scervicalspineinflexionto

applytensiontotheposteriorstructures.Thetapew

askept insitufor1day. O

nestripwasanchoredattheacrom

ion,withprojectionto

thetrapeziusmuscle.W

iththeneckinflexion,lateral flexionandrotation,aY

-stripwasappliedfrom

mastoid

processtoT1-T

2.Usualcare(seeright)w

asalsogiven. Tw

otreatmentsessionsw

ereprovidedeachweekfor6

weeks.

Inforwardbend,3stripsw

ereappliedalongthespinous processesandparaspinallybetw

eenT12andL

5.Subjects

wereaskedtobendforw

ardduringthetapingprocedure; notensionw

asusedotherthanthatrequiredtocoverthe

backinbendingposition.Thetapew

aschangedevery3–4

daysfor1month.

KTandexercise:asdescribedaboveandatright

Multi-m

odality:analgesics,heat, cold,andunspecifiedphysical therapytechniques.T

henumber

anddurationoftreatmentsisnot

stated.C

on:shamtaping.W

iththeneck

inaneutralpositionand

applyingnotensiontothetape, oneI-stripw

asplacedoverC1

toT2,andoneI-stripw

asplaced

perpendicularoverthe

midcervicalregion.T

hetape

waskeptinsitufor1day.

Con:usualcare.C

ervicalmuscle

stretching,cervicalmobility,

musclestrengtheningexercises,

andmassage.Tw

otreatment

sessionswereprovidedeach

weekfor6w

eeks. E

xercises:30minofexercises,

3/wkx4w

k,including

relaxation,stretchingandactive

exercisesfortheabdominal,

backextensors,psoas, ham

stringsandpelvicmuscles

KinesioTapingform


arreira

Page12of40

25

Saavedra

- Hernand

ez2012

n=76

mechanical

idiopathicneckpain

Age(yr)=

exp46

(SD

9),con44(SD

10)

Sim

sek

2013

Thelen

2008

n=42

rotatorcuff tendonitis/im

pingem

ent A

ge(yr)=exp21

(SD

2),con20(SD

2)

OneY

-stripwasappliedoversupraspinatusfrom

insertion

tooriginwithcontralateralcervicallateralflexionand

internalrotation,extensionandadductionoftheshoulder. O

neY-stripw

asappliedoverdeltoidfrominsertionto

originwiththearm

reachingtothecontralateralhip.OneI-

stripwasappliedfrom

thecoracoidprocesstotheposterior deltoidw

ith50–75%tension.T

hetaperemainedinsitufor

2periodsof48to72hr.

KinesioTapingform


arreira

Page13of40

n=38

subacromial

impingem

ent syndrom

e

Age(yr)=

exp49, con53

OneY

-stripwasappliedsym

metricallyovertheposterior

cervicalextensormuscles,w

ithpaper-offtensionandwith

cervicalcontralateralsidebendingandrotation.Thetape

wasappliedfrom

thedorsalregion(T1-T

2)totheupper cervicalregion(C

1-C2).A

noverlyingstripwasplaced

perpendiculartotheY-strip,overthem

idcervicalregion

(C3-C

6),withthepatient’scervicalspineinflexionto

applytensiontotheposteriorstructures.Thetapew

askept insitufor1w

eek. O

neY-stripw

asappliedoverdeltoidfrominsertionto

originandoneY-stripw

asappliedoversupraspinatusfrom

insertiontoorigin.AnI-stripw

asappliedfromthe

coracoidprocesstotheposteriordeltoidwith50–75%

tensioninamechanicalcorrectiontechnique.T

hetapewas

changedevery3daysfor12days.Usualcare(seeright)

wasalsogiven.

Manipulation:Tw

othrust m

anipulationsweredirectedat

themidcervicalspineand

cervicothoracicjunction.

Con:sham

tapingandusual care.Tw

oI-stripswereapplied

withnotension:overthe

acromioclavicularjointinthe

sagittalplane,andonthedistal deltoidinthetransverseplane. T

hetapewaschangedevery3

daysfor12days.Usualcarew

as supervisedexercisesforscapular stabilisationanddistalm

obility, 5–15repetitions,tw

icedailyfor 2w

eeks. C

on:shamtaping.Tw

oI-strips w

ereappliedwithnotension:

overtheacromioclavicularjoint

inthesagittalplane,andonthe

distaldeltoidinthetransverse plane.T

hetaperemainedinsitu

for2periodsof48to72hr.

26

Tsai n=

52

OneY

-stripwasappliedtothegastrocnem

iusandpalm-

Con:usualcare.T

herapeutic

2010

plantarfasciitis shapedtapingw

asappliedovertheplantarfascia.Thetape

ultrasound(3MH

z,5min)and

Age(yr)=

exp53

waskeptinsitufor1w

eek.Usualcare(seeright)w

asalso

low-frequencyT

EN

S(120H

z, (S

D29),con31(S

D

given.40m

s,15min)tothesiteof

13) pain,6tim

esin1week.

Exp=

experimentalgroup,con=

controlgroup,TE

NS

=transcutaneouselectricalnervestim

ulation. low

backpain,pesanserinussyndrome,tibialisanteriorsyndrom

e,cervicalspinesyndromeandshoulderarm

syndrome

a KinesioTapingform


arreira

Page14of40

27

Quality: The methodological quality and reporting of the eligible trials is presented in

Table 2. The total PEDro score ranged from 3 to 9, with a mean of 6.1. All trials

satisfied the items related to random allocation, between-group comparisons, and point

estimates and variability. The items least frequently satisfied were blinded therapists,

intention-to-treat analysis, blinded participants and concealed allocation. Among the 12

eligible trials, only 1 was registered, only 1 declared a primary outcome, none received

funding and 3 reported performing a sample size calculatio


28

Table2.Methodologicalqualityandreportingofeligiblestudies(n=

12). S

tudy

PE

DroS

caleItems

a

1b

2

Y

Y

Y

Y

Y

Y

YY

YN

Y

NN

NN

NYY

YY

YN

YY

YNN

NN

NN

NN

NYYYY

NY

YN

YY

NY

YYYYY

NY

NN

NY

NY

Y

34

56

78

91011

Akbas2011

Aytar2011

Cam

polo2013

Castro-S

anchez2012

Everm

ann2008

González-Iglesias

2009

Llopis2012

Paoloni2011

Saavedra-H

ernandez

2012

Sim

sek2013

Thelen2008

Tsai2010

Y

N

N

Y

Y

Y

NYY

NYN

NYN

NNN

YYY

YYN

NYN

YYY

YYY

5

9

5

Y

Y

YY

Y

Y

NY

Y

Y

NN

NNN

NNN

NYY

NYY

NYY

YYY

YYY

3

7

8

Y

Y

Y

N

Y

Y

PE

Dro

Score

(0to10) 5

7

3

9

4

8

Registered

Prim

ary?

outcomes

stated?N

NNNYNN

Funded?

N

Sam

plesize

calculation

presented?

N

NN

N

NN

N

YN

Y

NN

N

NN

N

NNN

NN

N

NN

N

NN

Y

NNN

NN

N

NN

Y

NN

N

Y=

yes,N=

no.a1=E

ligibilitycriteriaandsourceofparticipants,2=random

allocation,3=concealedallocation,4=

baselinecomparability,

5=blindedparticipants,6=

blindedtherapists,7=blindassessors,8=

adequatefollow-up,9=

intention-to-treatanalysis,10=betw

een-group

comparisons,11=

pointestimatesandvariability.bItem

1doesnotcontributetothetotalscore.

KinesioTapingform


arreira

Page16of40

29

Participants: Among the eligible trials, two (Castro-Sanchez et al 2012, Paoloni et al

2011) involved treatment of patients with chronic low back pain, two (Akbas et al 2011,

Aytar et al 2011) recruited patients with patellofemoral pain, two (Simsek et al 2013,

Thelen et al 2008) recruited patients with shoulder pain, three (González-Iglesias et al

2009, Saavedra-Hernandez et al 2012, Llopis and Aranda 2012) recruited patients with

neck pain, one (Campolo et al 2013) recruited patients with anterior knee pain, one

(Tsai et al 2010) recruited patients with plantar fasciitis and one (Evermann 2008)

recruited people with diverse musculoskeletal conditions.

Interventions: Among the eligible trials, one (Campolo et al 2013) compared Kinesio

Taping with no treatment, four (Aytar et al 2011, Castro-Sanchez et al 2012, González-

Iglesias et al 2009, Thelen et al 2008) compared Kinesio Taping with sham Kinesio

Taping, four (Campolo et al 2013, Evermann 2008, Paoloni et al 2011, Saavedra-

Hernandez et al 2012,) compared Kinesio Taping with other interventions, and five

(Akbas et al 2011, Llopis and Aranda 2012, Paolini et al 2011, Simsek et al 2013, Tsai

et al 2010) compared Kinesio Taping plus other interventions with other interventions

alone. The other interventions in the studies ranged from other formal taping methods,

exercise, manual techinques, analgesics, heat, cold, stretches and electrotherapy. The

treatment periods ranged from a single application of taping to 6 weeks.

Outcomes measures: Pain intensity was measured using a Visual Analogue Scale

(Aytar et al 2011, Castro-Sanchez et al 2012, Paoloni et al 2011, Thelen et al 2008), a

Numerical Pain Rating Scale (González-Iglesias et al 2009, Saavedra-Hernandez et al

2012), and the McGill Melzack Pain Questionnaire (Tsai et al 2010). Disability was

measured using the Oswestry Disability Index (Castro-Sanchez et al 2012), the Roland

Morris Disability Questionnaire (Castro-Sanchez et al 2012, Paoloni et al 2011), the

Shoulder Pain and Disability Index (Thelen et al 2008), the Anterior Knee Pain Scale

(Akbas et al 2011), the Kujala Scale (Akbas et al 2011), and the Neck Disability Index

(Saavedra-Hernandez et al 2012). Quality of life was measured in one trial (Llopis and

Aranda 2012) using the SF-36 Questionnaire. The follow-up periods ranged from

immediately after application of the Kinesio Taping to six weeks from randomisation.

One trial (Evermann 2008) contained insufficient data about eligible outcomes to

calculate quantative results. We contacted the authors but did not receive the requested

data, so reporting of this trial is limited to statistical significance.


30

Effect of Kinesio Taping versus no treatment

One trial compared Kinesio taping versus no treatment (Campolo et al 2013), with 20

participants assessed under both conditions. Kinesio Taping reduced anterior knee pain

during stair ascent/descent, as presented in Table 3. However, the median effect of 0.5

on a pain scale from 0 to 10 was lower than the threshold of clinical importance

nominated in the study. Despite this, the authors concluded that Kinesio Taping may be

effective. The quality of evidence (GRADE) for this comparison was rated “very low

quality” (ie, single trial with high risk of bias).


31

Table3.ResultsandconclusionsofstudiesofK

inesioTapingversusnotreatment(n=

1).

Study

condition

Cam

polo

2013

Uponapplicationof

KT

(ornotape

condition) kneepain

Tim

epoint R

esults

Pain(0to10)duringw

eightedsquatlift:differencein

medians=

1infavourofKT,p=

0.275.MD

:1(95%C

I=

0.67to1.33)

Pain(0to10)ascendinganddescendingstairs:difference

inmedians=

0.5infavourofKT,p=

0.034.MD

:0.50

(95%C

I=0.13to0.87).

Conclusions

Author:K

Tm

aybeeffectivein

reducinganteriorkneepain

duringstairclimbingactivities.

Review

:KT

didnotsignificantly

reducepainduringsquats.KT

reducedpainonstairs,butthe

effectmaybetoosm

alltobe

clinicallyworthw

hile.Thestudy

hadlowm

ethodologicalquality.

KinesioTapingform


arreira

Page19of40

KT

=K

inesioTaping,MD

=M

eanDifference

32

Effect of Kinesio Taping versus sham taping

Four randomised trials involving 164 participants compared Kinesio Taping versus

sham (Aytar et al 2011, Castro-Sanchez et al 2012, González-Iglesias et al 2009, Thelen

et al 2008), as presented in Table 4. The four trials involved participants with

patellofemoral pain, shoulder pain, whiplash or low back pain, and the outcomes

evaluated were pain and disability. Kinesio Taping was either no more effective than

sham taping, or its effect was too small to be considered clinically worthwhile by the

original authors and the reviewers. All four trials were single studies (ie, no two studies

examined the same patient population) with low risk of bias, therefore the quality of

evidence (GRADE) was rated as “low quality”.

Figure 2 presents two forest plots for the studies that compared the use of Kinesio

Taping versus sham taping. These trials could not be pooled into a meta-analysis due to

clinical heterogeneity (as the musculoskeletal conditions were different). In general,

Kinesio Taping was not better than sham treatment.


33


inesioTapingversusshamtaping(n=

4).

Study

condition

Aytar

2011

kneepain

AfterK

Tor sham

tapinghad

beeninsitufor 45m

in

Tim

epoint R

esultsC

onclusions

Castro-

Sanchez

2012

backpain

Imm

ediately

after7daysof K

Torsham

taping

4wkafterthe

periodofKTor

shamtaping

Upon

applicationof K

Torsham

taping

AfterK

Tor sham

tapinghad

beeninsitufor 24hr U

pon

applicationof K

Torsham

Pain(0to10)ascendingstairs:M

D0.3(95%

CI-1.4to2.0)in

A

uthor:KT

didnotsignificantly

favourofsham

reducepain.

Pain(0to10)descendingstairs:M

D1.3(95%

CI-0.7to3.3)in

R

eview:K

Tdidnotsignificantly

favourofsham

reducepain.

Pain(0to10)w

alking:MD

0.1(95%C

I-1.9to2.1)infavourof sham

Pain(0to10):M

D1.1(95%

CI0.3to1.9)infavourofK

T

Author:K

Treduceddisability

andpain,buttheseeffectsmay

D

isabilitya(0to100):M

D4(95%

CI2to6)infavourofK

T

Disability

b(0to24):MD

1.2(95%C

I0.4to2.0)infavourofKT

betoosmalltobeclinically

worthw

hile.

Review

:KT

reduceddisability

(short-termonly)andpain,but

theseeffectsmaybetoosm

allto

beclinicallyworthw

hile.

Pain(0to10):M

D1.0(95%


T

Disability

a(0to100):MD

1(95%C

I-1to3)infavourofsham

Disability

b(0to24):MD

0.1(95%C

I-1.0to1.3)infavourof

sham

Pain(0to10):M

D0.9(95%


T

Gonzalez-

Iglesias 2009

neckpain

Pain(0to10):M

D1.1(95%


T

Author:K

Treducedpain,but

theeffectmaybetoosm

alltobe clinicallyw

orthwhile.

Review

:KT

reducedpain,but theeffectm

aybetoosmalltobe

clinicallyworthw

hile.

Pain(0to10):M

D0.6(95%

CI-0.2to1.5)infavourofK

T

Thelen

2008

Author:K


reducepainordisability.

KinesioTapingform


arreira

Page21of40

34

shoulder pain

AfterK

Tor sham

tapinghad

beeninsitufor3

days A

fterKTor

shamtapinghad

beeninsitufor6

days

taping

Pain(0to10):M

D0.4(95%

CI-1.2to1.9)infavourofsham

Disability

c(0to100):MD

0.1(95%C


KT

Pain(0to10):M

D0.3(95%

CI-1.4to2.1)infavourofsham

Disability

c(0to100):MD

0.2(95%C

I-1.0to1.5)infavourof K

T

Review

:KT

didnotsignificantly

reducepainordisability.

KT

=K

inesioTaping,sh=shoulder.aO

swestryD

iabilityIndex,bRoland-M

orrisDisabilityQ

uestionnaire,cShoulderP

ain&D

isabilityIndex,

MD

=M

eanDifference

.

KinesioTapingform


arreira

Page22of40

35

Figure2.M

eandifferenceofKinesioTapingversussham

tapinginpatientswithm

usculoskeletalconditionsfortheoutcomespain(A

)and

disability(B).N

otethatnopoolingisconductedbecausetheclinicalconditionsoftheparticipantsdiffer.

A

KinesioTapingform


arreira

Page23of40

B

36

Effect of Kinesio Taping versus other interventions

Four studies compared Kinesio Taping versus other interventions (Campolo et al 2013,

Evermann 2008, Paoloni et al 2011, Saavedra-Hernandez et al 2012) involving 200

participants. The results and conclusions of these studies are presented in Table 5. Two

trials were single studies with low risk of bias for patients with chronic low back pain

(Paoloni et al 2011) and acute whiplash (Saavedra-Hernandez et al 2012). The quality of

evidence (GRADE) for these studies was rated as “low quality”. These studies showed

that the effects of Kinesio Taping were no greater than the interventions to which they

were compared (ie, exercises and thrust manipulations, respectively) or any benefit was

too small to be clinically worthwhile. Two trials were single studies with high risk of

bias for patients with different musculoskeletal conditions (Evermann 2008) and

patients with anterior knee pain (Campolo et al 2013). Campolo et al (2013) showed

that Kinesio Taping did not have significantly greater benefits than McConnell patellar

taping for anterior knee pain. Evermann (2008) did not report between-group

differences in pain severity as a continuous outcome at equivalent time points, but did

report significantly more rapid resolution of symptoms with Kinesio Taping than with

multi-modality physiotherapy. However, the quality of evidence (GRADE) for these

studies was rated as “very low quality”.


37


inesioTapingversusotherinterventions(n=4).

Study

T

imepoint

Results

condition

Cam

polo

2013

kneepain

Upon

applicationof K

Tor M

cConnell

patellar taping

Conclusions

Pain(0to10)duringw

eightedsquatlift:differenceinmedians

=0.5infavourofM

cConnellPatellarTaping,p=

0.275.MD

:- 0.5(95%

CI=

-0.75to-0.25).

Pain(0to10)ascendinganddescendingstairs:differencein

medians=

0,p=0.87.M

D:0.0(95%

CI=

-0.28to0.28)

Everm

ann

2008

musculoskele

tal conditions

a

Paolini2011

lowback

pain

Upon

applicationof K

Torthe

firstmulti-

modality

physiotherap

ytreatment,

andafter1,2, 3,7and14

days A

t com

pletionof 4w

kofKT

orsupervised

group

exercises

Nodatacom

paringpainseveritybetweengroupsatequivalent

timepointsw

erereported.

KTcausedsignificantlyfasterresolutionofpainthanm

ulti- m

odalityphysiotherapy,bothoverallandwithindiagnostic

subgroups.

Author:K


reducepaincomparedto

McC

onnellpatellartaping.

Review

:KT

didnotsignificantly

reducepaincomparedto

McC

onnellPatellarTaping.The

studyhadlowm

ethodological quality.

Author:K

Tiseffective.K

Tis

superiortoconventional, orthodoxtreatm

entmethods.

Review

:KT

reducedthetimeto

resolutionofpaincomparedto

multi-m

odalityphysiotherapy. T

hestudyhadlow

methodologicalquality.

Pain(0to10):M

D0.4(95%


T

Disability

b(0to24):MD

4.1(95%C


exercises

Author:K

Tcannotsubstitutefor therapeuticexercises.

Review

:KT

didnotsignificantly

reducepainordisability

comparedtosupervised

exercises.

KinesioTapingform


arreira

Page25of40

38

Saavedra-

Hernandez

2012

neckpain

Onew

eek

Pain(0to10):M

D0.2(95%


T

after D

isabilityc(0to50):M

D0.3(95%

CI-1.3to1.9)infavourof

applicationofKT

KTor

cervical thrust m

anipulation

s

Author:K

Tandcervicalthrust m

anipulationshavesimilar

effectsonpainanddisability.

Review

:Com

paredtocervical thrustm

anipulations,KT

reducespainbutnottoa

clinicallyworthw

hiledegreeand

doesnotimprovedisability.

KT

=K

inesioTaping.alowbackpain,pesanserinussyndrom

e,tibialisanteriorsyndrome,cervicalspinesyndrom

eandshoulder-armsyndrom

e, R

oland-MorrisD

isabilityQuestionnaire,cN

eckDisabilityIndex,M

D=

MeanD

ifference.

b KinesioTapingform


arreira

Page26of40

39

Effect of Kinesio Taping plus other interventions versus other interventions alone

Five studies compared the addition of Kinesio Taping over other interventions versus

other interventions alone (Akbas et al 2011, Llopis et al 2012, Paolini et al 2011,

Simsek et al 2013, Tsai et al 2010) involving 170 participants. Kinesio Taping was not

better than other interventions alone for patients with rotator cuff lesion or/and

impingement shoulder syndrome, chronic neck pain, patellofemoral pain syndrome,

plantar fasciitis in the outcomes evaluated. These four trials (Akbas et al 2011, Llopis et

al 2012, Simsek et al 2013, Tsai et al 2010) were single studies with high risk of bias,

therefore the quality of evidence was rated as “very low quality”. The quality of

evidence for one trial in low back pain (Paolini et al 2012) with low risk of bias was

rated as “low quality”. The results and conclusions are presented in Table 6. Kinesio Taping for musculoskeletal disorders Parreira Page 27 of 40

40


inesioTapingplusotherinterventionversusotherinterventiononly(n=5).

Study

condition

Akbas2011

kneepain

After3w

kof K

Tplus

exercisesor exercisesonly

Tim

epoint R

esults

Pain(0to10)

atrest:MD

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kneeling:MD

1.4(95%C


walking:M

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squatting:MD

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only

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kneeling:MD

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kof K

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Conclusions

KinesioTapingform


arreira

Page28of40

Author:A

ddingKT

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conventionalexercises doesnotreducepainor disability.

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exercisesdoesnotreduce

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methodologicalquality.

41

goinguphill:MD

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prove

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hadlowm


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Page29of40

42

Paolini

2011

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Atcom

pletion

of4wkofK

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D9.6(95%


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aybeused

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exercisesimprovespain

anddisability.Thestudy

hadlowm


43

Tsai2010

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berofwordschosentodescribethepainonapain

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uthor:AddingK

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plus characteristicsquestionnaire

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or afterK

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arkeddifferencein

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plus electrotherapy

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plus electrotherapy

totalscore:MD

19(95%C

I8to31)infavourofKT

plus electrotherapy

KT

=K

inesioTaping,TE

NS

=transcutaneouselectricalnervestim

ulation.aKujalaS

cale,bShortF

orm36questionnaire,cR

oland-Morris

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KinesioTapingform


arreira

Page31of40

44

DISCUSSION

This review aimed to summarise the current evidence of the effects of Kinesio Taping

in patients with musculoskeletal conditions. Ten of the included randomised trials

estimated the effect of Kinesio Taping by comparing it to sham taping or no

intervention, or by comparing its effect when added to other interventions. In general,

Kinesio Taping either provided no significant benefit, or its effect was too small to be

clinically worthwhile. Two trials did find a significant benefit from Kinesio Taping

where the confidence interval was wide enough to include some clinically worthwhile

effects, but these trials were of low quality. The effect of Kinesio Taping was also

compared to the effects of other physiotherapy interventions in four trials. The only one

of these trials to identify a significant benefit was again of low quality.

On average, the trials identified in this review were small with moderate methodological

quality. Despite several benefits of registering a clinical trial (Costa et al 2012, Pinto et

al 2012), only one out of the twelve trials was registered (Castro-Sanchez et al 2012).

Out of the twelve trials, only three provided transparent information on sample size

calculation (Castro-Sanchez et al 2012, Saavedra-Hernandez et al 2012, Thelen et al

2008), only one provided information about primary outcomes (Castro-Sanchez et al

2012) and none stated that their trial received funding. The quality of evidence

(GRADE) for all comparisons ranged from low to very low quality, which means that

further robust and low risk of bias evidence is likely to change the estimates of the

effects of this intervention.

This systematic review used a highly sensitive search strategy to identify trials in all

major databases, following the recommendations from the Cochrane Collaboration

(Furlan et al 2009). Our searches were also supplemented by the identification of

potential eligible studies from hand searching as well as in clinical trials registries.

Therefore we are confident that our searches comprehensively identified most or all of

the current high-quality evidence about Kinesio Taping in patients with musculoskeletal

conditions. However it is possible that some trials might be published in local databases

and as a consequence were not included in our review.


45

A strength of our review compared to previous reviews is a larger number of relevant

clinical trials in participants with musculoskeletal conditions. However, the conclusions

from all previous reviews (including ours) are very similar (Bassett et al 2010, Kalron et

al 2013, Morris et al 2012, Mostafavifar et al 2012, Williams et al 2012). These findings

confirm that this intervention cannot be considered as effective for this population. We

preferred to describe only patient-centered outcomes as these outcomes are the ones that

are considered the most important in clinical practice for both clinicians and patients.

The included trials compared the Kinesio Taping with a large range of comparators (ie,

no treatment, sham taping, exercises, manual therapy, and electrotherapy). Regardless

of the comparison used or the outcomes investigated, the trials typically showed no

significant difference in outcomes between the groups or a trivial effect in favour of

Kinesio Taping, ie, small enough to not be considered clinically worthwhile. It seems

that the growing use of Kinesio Taping is much more due to massive marketing

campaigns (such as the ones used during the London 2012 Olympic Games) than by

clinical, high quality, scientific evidence. The widespread use of Kinesio Taping in

musculoskeletal and sports physical therapy is probably further reinforced by the

authors in some of the included trials concluding that Kinesio Taping was effective

when their data did not identify significant benefits. Policymakers and clinicians should

carefully consider the costs and the effectiveness of this intervention when deciding

whether to use this intervention.

Although Kinesio Taping is widely used in clinical practice, the current evidence does

not support the use of this intervention. However, the conclusions from this review are

based on a number of underpowered studies. Therefore large and well-designed trials in

patients are strongly needed. Our research group is currently conducting two large

randomised controlled trials investigating the use of Kinesio Taping in patients with

chronic low back pain which should provide new and high quality information on this

topic. One of them (Parreira et al 2013) compares different types of application of

Kinesio Taping in 148 patients with non-specific chronic low back pain on the

outcomes pain intensity, disability and global impression of recovery. The second trial

(Added et al 2013) will test the effectiveness of the addition of Kinesio Taping to

conventional physical therapy treatment in 148 patients with chronic non-specific low

back pain on the outcomes pain intensity, disability, global impression of recovery and Kinesio Taping for musculoskeletal disorders Parreira Page 33 of 40

46

satisfaction with care. We expect that these two trials will contribute to a better

understanding about the effectiveness of this intervention. REFERENCES

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Akbas E, Atay AO, Yuksel I (2011) The effects of additional kinesio taping over exercise in the treatment of patellofemoral pain syndrome. Acta Orthopaedica et Traumatologica Turcica 45: 335–341.

Aytar A, Ozunlu N, Surenkok O, Karatas M (2011) Initial effects of kinesio® taping in patients with patellofemoral pain syndrome: A randomized, double-blind study. Isokinetics and Exercise Science 19: 135–142.

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Castro-Sanchez AM, Lara-Palomo IC, Mataran-Penarrocha GA, Fernandez-Sanchez M, Sanchez-Labraca N, Arroyo-Morales M (2012) Kinesio Taping reduces disability and pain slightly in chronic non-specific low back pain: a randomised trial. Journal of Physiotherapy 58: 89–95.

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González-Iglesias J, Fernández-de-las-Penas C, Cleland JA, Huijbregts P (2009) Short- term effects of cervical kinesio taping on pain and cervical range of motion in patients with acute whiplash injury: a randomized clinical trial. Journal of Orthopaedic &

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Guyatt GH, Oxman AD, Kunz R, Woodcock J, Brozek J, Helfand M, et al (2011) GRADE guidelines: 7. Rating the quality of evidence--inconsistency. Journal of Clinical Epidemiology 64: 1294–1302.

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Kalron A, Bar-Sela S (2013) A systematic review of the effectiveness of Kinesio Taping® - Fact or fashion? European Journal of Physical & Rehabilitation Medicine. Epub Ahead of Print.

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48

Morris D, Jones D, Ryan H, Ryan CG (2012) The clinical effects of Kinesio Tex taping: A systematic review. Physiotherapy Theory and Practice 4: 259–270.

Mostafavifar M, Wertz J, Borchers J (2012) A systematic review of the effectiveness of kinesio taping for musculoskeletal injury. Physician and Sportsmedicine 40: 33–40.

Paoloni M, Bernetti A, Fratocchi G, Mangone M, Parrinello L, Del Pilar Cooper M, et al (2011) Kinesio Taping applied to lumbar muscles influences clinical and electromyographic characteristics in chronic low back pain patients. European Journal of Physical & Rehabilitation Medicine 47: 237–244.

Parreira PdoCS, Costa LdaCM, Takahashi R, Hespanhol Junior LC, Motta TM, da Luz Junior MA, et al (2013) Do convolutions in Kinesio Taping matter? Comparison of two Kinesio Taping approaches in patients with chronic non-specific low back pain: protocol of a randomised trial. Journal of Physiotherapy 59: 52.

Pinto RZ, Elkins MR, Moseley AM, Sherrington C, Herbert RD, Maher CG, et al (2012) Many Randomized Trials of Physical Therapy Interventions Are Not Adequately Registered: A Survey of 200 Published Trials. Physical Therapy 93: 299–309.

Saavedra-Hernandez M, Castro-Sanchez AM, Arroyo-Morales M, Cleland JA, Lara- Palomo IC, Fernandez-de-Las-Penas C (2012) Short-term effects of kinesio taping versus cervical thrust manipulation in patients with mechanical neck pain: a randomized clinical trial. Journal of Orthopaedic & Sports Physical Therapy 42: 724–730.

Sherrington C, Herbert RD, Maher CG, Moseley AM (2000) PEDro. A database of randomized trials and systematic reviews in physiotherapy. Manual Therapy 5: 223– 226.

Shiwa SR, Costa LO, Costa LdaC, Moseley A, Hespanhol Junior LC, Venancio R, et al (2011) Reproducibility of the Portuguese version of the PEDro Scale. Caderno de Saude Publica 27: 2063–2068.

Simsek HH, Balki S, Keklik SS, Ozturk H, Elden H (2013) Does Kinesio taping in addition to exercise therapy improve the outcomes in subacromial impingement syndrome? A randomized, double-blind, controlled clinical trial. Acta Orthopaedica et Traumatologica Turcica 47: 104–110.

Thelen MD, Dauber JA, Stoneman PD (2008) The clinical efficacy of kinesio tape for shoulder pain: a randomized, double-blinded, clinical trial. Journal of Orthopaedic &

Sports Physical Therapy 38: 389–395.

Tsai CT, Chang WD, Lee JP (2010) Effects of short-term treatment with kinesiotaping for plantar fasciitis. Journal of Musculoskeletal Pain 18: 71–80. Kinesio Taping for musculoskeletal disorders Parreira Page 36 of 40

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Williams S, Whatman C, Hume PA, Sheerin K (2012) Kinesio taping in treatment and prevention of sports injuries: a meta-analysis of the evidence for its effectiveness. Sports Medicine 42: 153–164. Websites www.pedro.org.au/english/downloads/confidence-interval-calculator


50

Appendix 1 – Search strategies

MEDLINE

1 kinesiotaping 2 kinesio taping 3 kinesiotape 4 kinesio tape 5 randomized controlled trial.pt. 6 controlled clinical trial.pt. 7 randomized.ab. 8 placebo.ab,ti. 9 drug therapy.fs. 10 randomly.ab,ti. 11 trial.ab,ti. 12 groups.ab,ti. 13 or/1-4 14 or/5-12 15 13 and 14 16 (animals not (humans and animals)).sh. 15 15 not 16

Embase 1kinesiotaping 2 kinesio taping 3 kinesiotape 4 kinesio tape 5 or/1-4 6 Clinical Article/ 7 exp Clinical Study/ 8 Clinical Trial/ 9 Controlled Study/ 10 Randomized Controlled Trial/ 11 Major Clinical Study/ 12 Double Blind Procedure/ 13 Multicenter Study/ 14 Single Blind Procedure/ 15 Phase 3 Clinical Trial/ 16 Phase 4 Clinical Trial/ 17 crossover procedure/ 18 placebo/ 19 or/6-18 20 allocat$.mp. 21 assign$.mp. 22 blind$.mp. 23 (clinic$ adj25 (study or trial)).mp. 24 compar$.mp. 25 control$.mp. 26 cross?over.mp. 27 factorial$.mp. 28 follow?up.mp.


51

29 placebo$.mp. 30 prospectiv$.mp. 31 random$.mp. 32 ((singl$ or doubl$ or trebl$ or tripl$) adj25 (blind$ or mask$)).mp. 33 trial.mp. 34 (versus or vs).mp. 35 or/20-34 36 19 and 35 37 human/ 38 Nonhuman/ 39 exp ANIMAL/ 40 Animal Experiment/ 41 or/38-40 42 37 not 41 43 36 not 31 44 42 and 43 45 43 or 44

CINAHL

S1 kinesiotaping S2 kinesio taping S3 kinesiotape S4 kinesio tape S5 S1 or S2 or S3 or S4 S6 (MH "Clinical Trials+") S7 "randomi?ed controlled trial*" S8 clinical W3 trial S9 double-blind S10 single-blind S11 triple-blind S12 S6 or S7 or S8 or S9 or S10 or S11 S13 (MH "Placebo Effect") S14 (MH "Placebos") S15 placebo* S16 random* S17 S13 or S14 or S15 or S16 S18 (MH "Random Sample") S19 (MH "Study Design+") S20 latin square S21 (MH "Comparative Studies") S22 (MH "Evaluation Research+") S23 (MH "Prospective Studies+") S24 S18 or S19 or S20 or S21 or S22 or S23 S25 follow-up stud* S26 followup stud* S27 control* S28 prospectiv* S29 volunteer* S30 S25 or S26 or S27 or S28 or S29 S31 S12 or S17 or S24 or S30


52

S32 (MH "Animals") S33 S31 NOT S32

PEDro 1 kinesiotaping 2 kinesio taping 3 kinesiotape 4 kinesio tape *search strategy was performed for each term at a time, with the option “clinical trial” checked

SciELO

1 kinesiotaping 2 kinesio taping 3 kinesiotape 4 kinesio tape 5 1OR 2 OR 3 OR 4

SPORTDiscus 1 tx kinesiotaping 2 tx kinesio taping 3 tx kinesiotape 4 tx kinesio tape *search strategy was performed by selecting “peer reviewed and academic journals” options

LILACS 1 kinesiotaping 2 kinesio taping 3 “kinesio” “taping” 4 kinesiotape 5 kinesio tape 6 “kinesio” “tape” 7 1OR 2 OR 3 OR 4 OR 5 OR 6


53

Capítulo 3

Do convolutions in Kinesio Taping matter? Comparison of two Kinesio

Taping approaches in patients with chronic non-specific low back

pain: protocol of a randomised trial

54

Research Trial Protocol

Do convolutions in Kinesio Taping matter? Comparison

of two Kinesio Taping approaches in patients with chronic non-specific low back pain: protocol of a randomised trial

Patrícia do Carmo Silva Parreira1, Luciola da Cunha Menezes Costa1,2, Ricardo Takahashi3, Luiz Carlos Hespanhol Junior1, Tatiane Motta Silva1, Maurício Antônio da Luz Junior1 and Leonardo

Oliveira Pena Costa1,2 1Universidade Cidade de São Paulo, Brazil, 2Musculoskeletal Division – The George Institute for Global Health, Australia, 3Private Physiotherapist,

Brazil

Abstract Introduction: Chronic low back pain is a common condition. A new intervention that is popular in sports has been used in patients with low back pain. This technique is based on the use of elastic tapes that are fixed on the skin of patients using different tensions and is named Kinesio Taping Method. Although this intervention has been widely used, to date the evidence of its effectiveness is lacking. Research Question: Is the application of the Kinesio Taping Method according to the treatment manual (with convolutions in neutral position) more efficacious than a simple application without convolutions in patients with chronic low back pain? Design: Two-arm randomised controlled trial with a blinded assessor. Participants and Setting: 148 patients with chronic low back pain from two outpatient physiotherapy clinics in Brazil. Intervention: 8 sessions of Kinesio Taping according to the Kinesio Taping Method treatment manual (ie, 10–15% tension with the treated muscles in stretching position and with convolutions in neutral). Control: 8 sessions of Kinesio Taping having no convolutions in neutral (0% tension) with the treated muscles in resting position. Measurements: Clinical outcomes (pain intensity, disability and global impression of recovery) will be obtained in assessments that will be

Commentary Kinesio Taping has become an important adjunct to physiotherapy treatment in recent years, possibly enhanced by images of its use by high profile sports people. However, the evidence supporting Kinesio Taping and its proposed mechanisms of action are nascent and further well- designed, controlled trials are required. This protocol describes a study that will investigate the hypothesised mechanisms that underpin Kinesio Taping, specifically those that suggest creating convolutions in the skin facilitate the effect of taping. Investigation of the mechanism by which a widely applied therapeutic modality may have an effect is worthwhile as it may improve understanding of the condition and highlight additional approaches that may also be effective.

performed at 4 weeks and 3 months after randomisation. Analysis: The effects of the intervention will be calculated through linear mixed models following intention-to-treat principles. Discussion: This is the largest study aimed to investigate the hypothesised mechanism behind the Kinesio Taping application in patients with chronic low back pain. The results of this study will contribute to a better understanding about the mechanisms of action of this widely applied therapeutic modality.

Trial registration: Brazilian Registry of Clinical Trials. Registration number: RBR-7ggfkv. Prospective registration: Yes. Funded by: Fundação de Amparo a Pesquisa do Estado de São Paulo (FAPESP), and Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq), Brazil. Approval number: FAPESP number 2011/12926-0; CNPq number 470652/2011-0. Anticipated completion: February 2013. Correspondence: Leonardo Oliveira Pena Costa, Rua Cesário Galeno 448, Tatuapé, São Paulo/SP, Brazil 03071-000 Email: [email protected]

Full protocol: Available on the eAddenda at jop. physiotherapy.asn.au

This well-constructed protocol proposes investigating chronic non-specific low back pain with a 4-week intervention and a 3-month follow-up period, with pain, function and perceived effect being monitored. The trial is exposed to some possibility of confounding as the heterogeneity of non-specific low back pain is well known and the participant numbers are small. However this trial may provide guidance to clinical reasoning and improve explanation to patients. This study may show reasons for effectiveness of Kinesio Taping, however large randomised trials of Kinesio Taping compared to sham/placebo control conditions are still needed.

Jill Cook Professor (research), Physiotherapy Department, Monash

University, Australia

52 Journal of Physiotherapy 2013 Vol. 59 – © Australian Physiotherapy Association 2013

55

eAddenda

Do convolutions in Kinesio Taping matter?

A comparison of two Kinesio Taping approaches in patients with chronic non-specific

low back pain: protocol of a randomised trial

Patrícia do Carmo Silva Parreira1, Luciola da Cunha Menezes Costa1,2, Ricardo

Takahashi3, Luiz Carlos Hespanhol Junior1, Tatiane Motta Silva1, Maurício Antônio da

Luz Junior1 and Leonardo Oliveira Pena Costa1,2

1 Universidade Cidade de São Paulo, Brazil, 2Musculoskeletal Division – The George

Institute for Global Health, Australia, 3Private Physiotherapist, Brazil

Journal of Physiotherapy Vol 59 No 1

p 52

Complete protocol

©Copyright Australian Physiotherapy Association 2013

Page 1 of 12

56

Introduction

Chronic low back pain is a very prevalent condition (Hoy et al 2012) which is associated with

disability and imposes an enormous economic burden to the society (Dagenais et al 2008).

Patients with chronic low back pain usually experience improvements in the first six weeks

after the onset of chronicity but then very small reductions in pain and disability are observed

between six weeks and one year (Costa et al 2012). Therefore, due to this unfavourable

prognosis, a large number of patients with chronic low back pain seek care for their

symptoms. There is a wide variety of treatment options for chronic low back that are

endorsed by clinical practice guidelines (Airaksinen et al 2006, Delitto et al 2012), however

the magnitude of the effects of these interventions are, at best, small to moderate (Airaksinen

et al 2006). A new method of treatment that is very popular in sports physiotherapy is the Kinesio Taping

Method. This intervention has been recommended for patients with low back pain and is

based upon the use of specific elastic tapes (known as Kinesio Tex Gold®) that should be

applied with a certain amount of tension fixed to the skin of patients with the target muscles

in a stretched position (Kase et al 2003). The Kinesio Tex tape has been designed to allow for

a longitudinal stretch up to 140% of its resting length. The combination of the stretching

capacity of the Kinesio Tex Gold® tape with the muscle in a stretched position will create

convolutions as the skin is lifted. According to the treatment manual, these convolutions

would aid blood and lymphatic flow as well as reduce pain in patients with musculoskeletal

conditions (Kase et al 2003). The Kinesio Taping Method Manual states that ‘the proper

tension application is one of the most critical factors in the application´s success’ (Kase et al

2003 p.14). However, the theory that the amount of tension is important has never been tested

in a large, high quality randomised controlled trial in patients with chronic low back pain.

Therefore the research questions of this study are:

1. Is the application of Kinesio Taping according to the treatment manual (ie, generating

convolutions in the skin by applying the Kinesio Tape with a tension of 10–15%)

more efficacious than a simple application (ie, not generating convolutions in the skin

by applying the Kinesio Tape without any tension) with the treated muscles in resting

position in patients with chronic low back pain?

2. Can the effects observed after 4 weeks of treatment be sustained over 3 months after

randomisation?

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Method

Design

This will be an assessor-blinded, two-arm randomised controlled trial (Figure 1) that is

funded by the Fundação de Amparo a Pesquisa do Estado de São Paulo (FAPESP), and by

the Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq), Brazil.

Measurements will be taken at baseline, immediately following the intervention (4 weeks) as

well as at 3 months after randomisation to examine maintenance of any intervention effects.

The study protocol has been approved by the Universidade Cidade de São Paulo Research

Ethics Committee (research protocol number PP13603502) and has been prospectively

registered in the Brazilian Registry of Clinical Trials (Registration number: RBR-7ggfkv).

Triage to determine

participant eligibility

Randomization

n = 148

74 patients will be assigned to the no

convolutions in neutral group Patient allocation 74 patients will be assigned to the

convolutions in neutral group

Pain, disability, global impression of

recovery 4 weeks Pain, disability, global impression of

recovery

Pain, disability, global impression of recovery

Figure 1: Flow diagram of the study.

3 months follow-up

58

Pain, disability, global impression of recovery

Page 3 of 12

Participants, therapists, centres

We will recruit patients presenting with low back pain of at least three months’ duration, aged

between 18 and 80 years, of both genders, who are seeking treatment for low back pain.

Patients with any contraindication to physical exercise (ACSM 1995) according to the

guidelines of the American College of Sports Medicine; patients with serious spinal pathology

(including fractures, tumours and inflammatory diseases); nerve root compromise; serious

cardiopulmonary conditions; pregnancy; and patients with any contraindications to the use of

taping (such as skin allergy or intolerance to the tape material) will be excluded from the

study. Patients will be treated by three physiotherapists who were trained to deliver the Kinesio

Taping Method interventions by two certified Kinesio Taping Method practitioners. These

practitioners will audit the interventions whenever necessary. Each patient will be treated by

the same physiotherapist, who will not be involved in patient assessment. The trial will be

conducted in two outpatient physiotherapy clinics in the cities of São Paulo and Campo

Limpo Paulista, Brazil.

Intervention/control

A total of 148 patients will be randomly allocated to receive two different approaches of

Kinesio Taping Method application:

1. Experimental group – who will be taped with a I-Shape Kinesio Tex Gold® Tape

over the erector spinae muscle with 10–15% of tension (paper-off tension) with the

treated muscles in stretching position and having convolutions in neutral according to

the Kenzo Kase’s Kinesio Taping Method Manual (Kase et al 2003); and

2. Control group – who will be taped with a I-Shape Kinesio® Tex Tape over the

erector spinae muscle without tension (no convolutions in neutral) with the treated

muscle in resting position.

The treatments in both groups will be delivered during 4 weeks (8 treatment sessions, twice a

week, with three days interval between the sessions). During the study period, patients could

normally use the medications prescribed by their clinician. The use of any analgesics or anti-

inflammatory drugs will be monitored during the treatment sessions. All patients will be

orientated not to seek care or other type of treatment for their low back pain and they will be

allowed to maintain their regular activities, which will be also monitored during the treatment

sessions. Prior to the randomisation, patients will receive a patch test to rule out any allergic

Page 4 of 12

59

reaction. Patients will retain this patch for 24 hours, and if they do not have any allergic

reactions they will be randomised into one of the treatment groups. The Kinesio Taping Method uses elastic bandages that are attached in the patient´s skin over

the area to be treated. These bandages (Kinesio Tex Gold®) are comprised of polymer elastic

strand wrapped by 100% (Kase et al 2003) cotton fibers without latex (hypoallergenic). The

tape is waterproof, porous, with a thickness similar to the epidermis of the skin; it is adhesive,

being made of 100% acrylic which is activated by heat (Kase et al 2003). The elastic bandage

has been designed to stretch only in the longitudinal direction (which can be applied in

different cuts and curves) and may stretch up to 140% of its resting length, this elasticity

being similar to the elastic qualities of the human skin. The Kinesio Tex Gold ® Tape is

manufactured with approximately 10–15% of the available tension applied to the paper

substrate; its elastic qualities are effective for 3–5 days (Kase et al 2003). Several bandage application techniques can be used in patients with low back pain, such as

‘star’, ‘H’, ‘Y’, ‘X’ and ‘I’ techniques. In this study the tape will be applied using the’I’-

Shaped Kinesio Tex Gold® tape over the erector spinae muscle (bilaterally) parallel to the

spinous processes of the lumbar vertebrae (Figure 2). The reference points for taping will be

the posterior superior iliac spine and the T8 vertebrae. The experimental group will be taped

with I-Shaped Kinesio Tex Gold® tape over the erector spinae muscle with 10–15% of

tension (paper-off tension) with the treated muscles in stretching position and having

convolutions in neutral according to the Kenzo Kase’s Kinesio Taping Method Manual. The

procedure begins by placing the distal base of the Kinesio Tex strip approximately 2 inches

(5 cm) below the posterior superior iliac spine without tension – therefore, the therapist

should remove the tape from the paper backing in only the amount required to begin the base

application. Subsequently, for each ‘I’ strip application, the patient will be asked to move the

lumbar spine into flexion to position the erector spinae muscle in a stretched position, as

recommended by the manual (Kase et al 2003). Then the tape should be applied over the skin

with light tension (10–15% of available tension and creating convolutions in neutral), which

is also known as ‘paper-off’ tension. Once the distal base application is completed, the

therapist should tear the paper backing just below the base of the ‘I’ strip, leaving the paper

backing on the strip. As the ‘I’ strip is applied in the skin, the tape is removed from the paper

substrate using the ‘paper off’ tension (ie, 10–15% of available tension and creating

convolutions in neutral). Consequently, the tape application finishes by placing the proximal

base of the Kinesio Tex strip approximately 2 inches (5 cm) above the vertebra T8 with 0%

Page 5 of 12

60

of tension and then the therapist should rub the Kinesio Tex Gold Tape to initiate the glue

adhesion (Figure 3).

Figure 2. I-Shape Kinesio Tex® Tape over the Erector Spinae muscle with 10–15% of tension (paper- off tension) with the treated muscles in stretching position according to the Kenzo Kase’s Kinesio taping manual.

The control group will be taped with an I-Shape Kinesio Tex Gold® tape over the erector

spinae muscle with no tension (no convolutions in neutral) and with the treated muscle in

resting position. The procedure begins by placing the distal base of the Kinesio Tex strip

approximately 2 inches (5 cm) below the posterior superior iliac spine without tension (no

convolutions in neutral), therefore, the therapist should remove the tape from the paper

backing in only the amount required to begin the base application. Subsequently, for each ‘I’

strip application, the patient will be asked to remain in standing position to keep the erector

spinae muscle in a non-stretched position. Then the tape should be applied over the skin

without tension (no convolutions in neutral). To apply the Kinesio Tex tape without tension,

the therapist should peel the remaining paper backing away (keeping only the paper backing

on the proximal base) to release the 10–15% of available tension that is applied to the tape

during manufacturing, bringing the tape to 0% of tension (no convolutions in neutral). Once

the therapist has removed the paper backing from the ‘I’ strip, the therapist should attach the

tape in the skin lightly. Consequently, the tape application finishes by placing the proximal

base of the Kinesio Tex Tape approximately 2 inches (5 cm) above the T8 vertebra without

convolutions in neutral then the therapist should rub the Kinesio Tex Tape to initiate the glue

adhesion.

Page 6 of 12

61

Figure 2a 2b 2c

Figure 3. I-Shape Kinesio Tex® Tape over the erector spinae muscle with no tension (0% tension) and with the treated muscle in a non-stretched position.

Prior to the tape application in both groups the skin will be cleaned with 70% alcohol to

improve the tape adherence, as the skin should be free of oils and lotions. Patients will remain

taped for two consecutive days and after this period patients will be instructed to remove the

tape, clean and treat the skin with a lotion moisturizer. The patients will remain without the

tape for 24 hours to allow for the skin to recover properly for the subsequent tape application.

Patients will be asked if the bandage is limiting lumbar movement and in these cases, the

Kinesio Tape will be reapplied so that they have unrestricted range of motion. After this

period, patients will return to the physiotherapy clinic and a new tape will be applied. This

process will be repeated for 4 weeks. There is no guarantee that the tape tension will be

maintained throughout the period of 48 hours, however it is not expected that the tension will

be reduced to 0%, unless the patient removes the tape early.

Outcome measures

A total of three outcome measures will be used: 1) Pain Numerical Rating Scale (NRS) to

determine the intensity of pain; 2) Roland Morris disability Questionnaire (RMDQ) (Roland

and Morris 1983) for the assessment of disability associated with back pain; and 3) Global

Perceived Effect Scale (GPE) (Fischer et al 1999) to evaluate the global impression of

recovery. The NRS, RMDQ and GPE have been properly translated, cross-culturally adapted

into Portuguese, and tested for their measurement properties in patients with low back pain in

Brazil (Costa et al 2008, Costa et al 2007, Nusbaum et al 2001). Their measurement

Page 7 of 12

62

Figure 3a 3b 3c

properties are acceptable and equivalent to the original English version. We will also record

any type of adverse effects that might occur (such as allergic reactions or skin problems, for

example).

Primary outcomes

The primary outcomes will be pain intensity and disability associated with low back pain

measured immediately after treatment (4 weeks).

Secondary outcomes

The secondary outcomes will be pain intensity and disability associated with low back pain

measured 3 months after randomisation and global impression of recovery measured

immediately after treatment (4 weeks) and 3 months after randomisation.

A detailed description of each of these outcome measures is presented as follows.

Pain Numerical Rating Scale. Pain intensity will be measured by the Brazilian-Portuguese

version of the 11-point Pain Numerical Rating Scale (Costa et al 2008). The pain NRS ranges

from 0 to 10, where 0 represents ‘no pain’ and 10 represents ‘worst possible pain’. The

participants will be asked to rate their levels of pain intensity based upon the last seven days.

This outcome will be measured at all time-points (ie, baseline, 4 weeks, and 3 months after

randomisation).

Roland Morris Disability Questionnaire. The Roland Morris Disability Questionnaire is an

instrument that is used widely in research and clinical practice for measuring disability

associated with low back pain (Roland and Morris 1983). This questionnaire contains 24

items related to daily activities that the patients may have difficulty performing due to low

back pain. The greater the number of items selected, the greater the disability. Participants

will be instructed to check the items that in fact describe them on the day of the assessment.

This outcome will be measured at all time-points (ie, baseline, 4 weeks, and 3 months after

randomization). Global Perceived Effect Scale. The Global Perceived Effect Scale is an 11-point scale

ranging from –5 (‘vastly worse’), through 0 (no change) to +5 (completely recovered)

(Fischer et al 1999). For all measures of global perceived effect (at baseline and in all follow-

ups), participants will be asked: ‘Compared to when this episode first started, how would you

describe your low back these days?’ A higher positive score indicates greater recovery and

Page 8 of 12

63

negative scores indicate worsening of the symptoms. This outcome will be measured at all

time-points (ie, baseline, 4 weeks, and 3 months after randomisation).

Procedure We will recruit patients with chronic low back pain (with symptoms of at least 3 months’

duration) who will be seeking care for their problem, as well as from the community. Patients

will be screened by a physiotherapist who will be unaware of treatment allocation in order to

confirm eligibility. This screening involves taking a careful medical history and a physical

examination. Eligible patients will be informed about the study objectives and procedures and

if they agree to participate in the study, they will sign a consent form. The physiotherapist

will then collect baseline data and will perform an allergy test in all patients. This allergy test

consists of applying a small Kinesio Tex Gold patch over the skin. Patients will keep this

patch on for 24 hours and will be instructed to remove the patch and call the chief

investigators if any allergic reaction occurs. Eligible patients without allergic reaction to the

patch test will be booked for the randomisation and first treatment session. The randomisation schedule was computer-generated by the chief investigator who will not

be involved in the recruitment or treatment of the patients. The allocation of subjects will be

concealed using numbered, sequentially ordered, sealed opaque envelopes. The envelopes

will be opened sequentially by the treating physiotherapists who will immediately provide the

first session of treatment to the patients. Clinical outcomes (pain intensity, disability, and global impression of recovery) will be

obtained in assessments that will be performed by a blinded assessor at 4 weeks and 3 months

after randomisation. Patients will be informed that they will receive one of two different

forms of Kinesio Taping application, therefore they cannot be considered as blinded. Due to

the nature of the interventions it will not be possible to blind the therapists. This randomised

controlled trial started recruitment in 1 April 2012 and the anticipated date of completion is

February 2013.

Data analysis

The analysis will be conducted by a statistician who will receive coded data. The effects of

the interventions for both primary and secondary outcomes will be calculated using Linear

Mixed Models. We will not perform secondary or subgroup analysis. The Statistical Package

for Social Sciences (SPSS) 19 will be used for the analysis. The sample size calculation for this study was based to detect a between-group difference of

1 point for pain intensity measured by the Portuguese version of the Pain Numerical Rating

Page 9 of 12

64

Scale (with an estimated standard deviation of 1.84 points), and 4 points for disability

measured by the Roland Morris Disability Questionnaire (estimated standard deviation of 4.9

points) with a statistical power of 80%, an alpha of 5%, and a possible loss to follow up of

15% across all time points. Therefore 74 patients per group (148 in total) will be needed.

Discussion The results of this study will contribute to a better understanding of the real importance of

convolutions in neutral for the effectiveness of Kinesio Taping method in patients with

chronic low back pain. As the evidence of the efficacy/effectiveness of this intervention is

still very limited (Castro-Sanchez et al 2012, Paoloni et al 2011), the results of this large,

high-quality randomised controlled trial may help physiotherapists on their clinical decision-

making process. This study has an adequate sample size to detect a clinical relevant treatment

effect with low risk of bias. In terms of pragmatism, this trial was designed to reproduce the

intervention exactly as is currently recommended by the treatment manual as well by certified

Kinesio Taping Method instructors, which enhances the clinical relevance of the trial results. Previous studies have not directly investigated the importance of the presence or absence of

convolutions, but according to the creators of the method, the success of therapy depends

largely on the presence of these convolutions. There is a possibility that the participants

allocated to the control group may still momentarily generate convolutions in their taping if

they move into a hyper-extension posture, but this stimulus is generated only on this

movement (as opposed to the patients from the intervention group who will generate

convolutions most of the time), therefore the likely benefits of convolutions will be much

smaller in the control group participants compared to the intervention group.

A very similar trial with low risk of bias was published recently (Castro-Sanchez et al 2012)

but with some important differences when compared to our study. First, the dosage used in

the previous published trial was much smaller than the one that will be used in our study (ie,

1 tape over a week versus 8 tapes over 4 weeks). Second, the authors of the previous study

observed the treatment effects at 7 days and 5 weeks after randomisation, while our study

time-points will be 4 and 12 weeks after randomisation. Third, our trial has a much larger

sample (n = 148), compared to the existing trial (n = 60). Finally, we do not consider our 0%

tension group as a placebo (Hancock et al 2006, Machado et al 2008), as it is unlikely that

any tape applied over the skin would be inert in terms of pain due to the gate control theory. Therefore the conclusions from our trial can add important information on the existing

evidence of the use of Kinesio Taping Method in patients with chronic low back pain.

Page 10 of 12

65

Human research ethics approval: Universidade Cidade de São Paulo Research Ethics

Committee, # PP13603502. Competing interests: The authors declare that they do not have any conflicts of interest to

declare. Acknowledgements: We would like to thank FAPESP and CNPq for funding this study. We

would also like to thank the Universidade Cidade de São Paulo and Clínica Luz for providing

the facilities for patients’ recruitment and treatment.

References ACSM (1995) ACSM's Guidelines for exercise testing and prescription. Baltimore: Williams

and Wilkins.

Airaksinen O, Brox JI, Cedraschi C, Hildebrandt J, Klaber-Moffett J, Kovacs F, et al (2006)

Chapter 4–European guidelines for the management of chronic nonspecific low back

pain. European Spine Journal 15: S192–S300.

Castro-Sanchez AM, Lara-Palomo IC, Mataran-Penarrocha GA, Fernandez-Sanchez M,

Sanchez-Labraca N, Arroyo-Morales M (2012) Kinesio Taping reduces disability and

pain slightly in chronic non-specific low back pain: a randomised trial. Journal of

Physiotherapy 58: 89–95.

Costa LCM, Maher CG, Hancock MJ, McAuley JH, Herbert RD, Costa LOP (2012) The

prognosis of acute and persistent low-back pain: a meta-analysis. Canadian Medical

Association Journal 184: E613–624.

Costa LOP, Maher CG, Latimer J, Ferreira PH, Ferreira ML, Pozzi GC, et al (2008)

Clinimetric testing of three self-report outcome measures for low back pain patients in

Brazil. Which one is the best? Spine 33: 2459–2463.

Costa LOP, Maher CG, Latimer J, Ferreira PH, Pozzi GC, Ribeiro RN (2007) Psychometric

characteristics of the Brazilian-Portuguese versions of the Functional Rating Index

and the Roland Morris Disability Questionnaire. Spine 32: 1902–1907.

Dagenais DC, Caro J, Haldeman S (2008) A systematic review of low back pain cost of

illness studies in the United States and internationally. The Spine Journal 8: 8–20.

Delitto A, George SZ, Van Dillen LR, Whitman JM, Sowa G, Shekelle P, et al (2012) Low

back pain. Journal of Orthopaedic and Sports Physical Therapy 42: A1–57.

Fischer D, Stewart AL, Bloch DA, Lorig K, Laurent D, Holman H (1999) Capturing the

patient's view of change as a clinical outcome measure. JAMA 282: 1157–1162.

Page 11 of 12

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Hancock MJ, Maher CG, Latimer J, McAuley JH (2006) Selecting an appropriate placebo

trial of spinal manipulative therapy. Australian Journal of Physiotherapy 52: 135–

138.

Hoy D, Bain C, Williams G, March L, Brooks P, Blyth F, et al (2012) A systematic review of

the global prevalence of low back pain. Arthritis and Rheumatism 64: 2028–2037.

Kase K, Wallis J, Kase T (2003) Clinical therapeutic applications of the kinesio taping

method (2nd edn). Tokyo, Japan: Kení-kai Information.

Machado LA, Kamper SJ, Herbert RD, Maher CG, McAuley JH (2008) Imperfect placebos

are common in low back pain trials: a systematic review of the literature. European

Spine Journal 17: 889-904.

Nusbaum L, Natour J, Ferraz MB, Goldenberg J (2001) Translation, adaptation and

validation of the Roland Morris questionnaire–Brazil Roland Morris. Brazilian

Journal of Medical and Biological Research 34: 203-210.

Paoloni M, Bernetti A, Fratocchi G, Mangone M, Parrinello L, Del Pilar Cooper M, et al

(2011) Kinesio Taping applied to lumbar muscles influences clinical and

electromyographic characteristics in chronic low back pain patients. European

Journal of Physical Rehabilitation Medicine 47: 237–244.

Roland M, Morris R (1983) A study of the natural history of low-back pain. Part II:

development of guidelines for trials of treatment in primary care. Spine (Phila Pa

1976) 8: 145–150.

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Editorial

Protocol papers published in Journal of Physiotherapy will strengthen the profession

Terry P Haines1,2 and Julia M Hush3 1 Allied Health Research Unit, Southern Health, 2Physiotherapy Department, Monash University, 3Discipline of Physiotherapy, Macquarie University

Australia

This 59th volume marks the first occasion of publication of clinical trial protocols in Journal of Physiotherapy. A trial protocol is a document that is developed before a research study commences. It provides the background and justification for the trial, describes the trial method, and documents how the data will be analysed. Protocols of clinical trials have been published in a number of health science journals for several years. It is recognised that this process helps to improve the standard and communication of health-related research in the following ways (Chalmers and Altman 1999, Eysenbach 2004):

• Allowing readers to compare the planned trial with how the trial was actually conducted

• Increasing transparency of statistical analyses, so that ‘data dredging’ can be easily identified and so that null, negative, or inconvenient findings are less likely to be concealed

• Assisting recruitment of potential trial centres and participants by increasing the visibility of upcoming trials

• Reducing duplication of research effort by enabling other researchers to see what trials are underway.

In addition, trial protocols are likely to be of value to clinical physiotherapists because they:

• Help physiotherapists easily stay abreast of the cutting edge of physiotherapy research

• Inform physiotherapists about current knowledge gaps and new ideas that drive the development of clinical trials

• Increase awareness of future directions in physiotherapy practice, which may facilitate a smoother transition of new research evidence into clinical practice

• Promote awareness of physiotherapy researchers around the world who are leaders in their field of practice.

It is the intention of the Journal of Physiotherapy Editorial Board that the protocols published in this journal will provide these benefits to the research and clinical communities. In alignment with the Journal’s standards of publication, published protocols will describe flagship trials that have been funded by nationally or internationally competitive funding schemes. The abstract of each protocol will be published in the printed issue, accompanied by a commentary from a distinguished expert in that field. The aim of the commentary is to help readers understand the potential impact that the trial will have on physiotherapy practice or the way we understand therapeutic modalities

and/or diseases managed by physiotherapists. The commentary will also highlight important strengths and limitations of the trial that will aid readers with their interpretation of the trial. The full trial protocol will be available online, for those who wish to read further detail about the study.

While the publication of trial protocols is one important step that can reduce misconduct in the publication of research findings, it is by no means a panacea for such wrongdoing, which may be the result of ineptitude or scientific fraud (Hush and Herbert 2009). For example, a review of protocols published in The Lancet found instances where the primary and secondary outcomes and subgroup analyses were different from those in the protocol (Al-Marzouki et al 2008). These insights from a leading medical journal with experience of publishing trial protocols have been useful in the development of clear criteria for authors considering publication of a trial protocol in Journal of Physiotherapy. Specifically, this Journal requires authors to provide a clear and logical description of the trial justification, a detailed description of the trial design, outcomes, interventions, and procedures. Particular attention will need to be paid to the planned analysis of data, so that the primary analyses and pre-planned secondary and subgroup analyses are described clearly and in their entirety. It is recognised that modifications to a trial protocol are not uncommon and are often brought about by factors outside the direct control of the investigators. Any such variations to the published protocol that occur during the conduct of the trial must be disclosed in full in the results papers and not be concealed.

The full range of benefits of published trial protocols will only be realised with detailed and complete description of the trial’s intended methods, open and transparent disclosure of any variations to the trial protocol by authors, and diligent comparison of manuscripts or papers reporting a trial’s results against the trial protocol by editors, reviewers, and readers. In this issue of the Journal, a trial protocol has been published that examines the theoretical rationale of the Kinesio Tape method; it is the first of a series of protocols of trials whose results will shape physiotherapy practice in the years to come.

References Al-Marzouki S et al (2008) Lancet 372: 201.

Chalmers I, Altman DG (1999) Lancet 353: 490–493. Eysenbach G (2004) J Med Internet Res 6: e37. Hush JM, Herbert RD (2009) Aust J Physiother 55: 77.

6 Journal of Physiotherapy 2013 Vol. 59 – © Australian Physiotherapy Association 2013 68

Apêndice 1

Apostila de Avaliação do Estudo

69

Nome:___________________________________________Data:____/____/______ Trial:________

Paciente está interessado em participar do estudo? Sim Não

Critérios de inclusão e de exclusão

Critérios de inclusão Todas as questões devem ser respondidas SIM para determinar a entrada do paciente no estudo

Sim Não

Dor lombar há pelo menos 3 meses

Idade entre 18 e 80 anos

Pacientes que estiverem procurando tratamento para dor lombar

Critérios de exclusão

Todas as questões devem ser respondidas NÃO para determinar a entrada do paciente no estudo

Sim Não

Contra indicações ao uso do Kinesio Taping (alergia ou intolerância ao material-

esparadrapos, fitas, band-aid, etc)

Gravidez

Patologias graves de coluna

Condições radiculares da coluna

Patologias cardiorrespiratórias

Comentários (Se o sujeito for inelegível, por favor, registrar abaixo o motivo): __________________________________________________________________________________

__________________________________________________________________________________

__________________________________________________________________________________

______________________________________________________________

70

COMITÊ DE ÉTICA EM PESQUISA DA UNIVERSIDADE CIDADE DE SÃO PAULO

(UNICID)

TERMO DE CONSENTIMENTO LIVRE E ESCLARECIDO

As informações que seguem estão sendo fornecidas para a sua participação voluntária nesta pesquisa cujo título é “Comparação de duas técnicas de Kinesio Taping em pacientes com dor lombar crônica não específica: um estudo controlado aleatorizado”.

Objetivos do estudo: testar a eficácia de duas formas distintas do uso do Kinesio Taping, uma aplicando apenas tensão da fita no papel sem nenhuma tensão externa aplicada pelo terapeuta (sem

tração) e tração definida a partir do julgamento clínico do terapeuta. Segue abaixo o planejamento da pesquisa:

1ª etapa - decisória para sua participação na pesquisa

Preenchimento da ficha de avaliação, que conterá informações como: dados pessoais, história do quadro da dor, características da dor e critérios de elegibilidade que determinarão sua participação ou não nessa pesquisa (apresentar dor lombar há 3 meses ou mais e não apresentar doença grave de coluna).

----------------------------------------------------------------------------------------------------------------

2ª etapa – avaliação

-Avaliação da intensidade dor na coluna - Pain Numerical Rating Scale

-Avaliação do quanto essa dor interfere na realização de suas atividades diárias - Roland Morris Disability Questionnaire

-Como os sintomas se apresentam no momento - Escala de Percepção do Efeito Global

-----------------------------------------------------------------------------------------------------------------

3ª etapa: Após a avaliação, o examinador sorteará um número que determinará com qual técnica você será atendido: sem tração ou e tração definida a partir do julgamento clínico do terapeuta.Serão realizadas 8 sessões de tratamento (2 vezes por semana com dois dias de intervalo entre elas), durante quatro semanas.

---------------------------------------------------------------------------------------------------------------

4ª etapa: a avaliação será realizada novamente com 4 semanas, 3 meses pós randomização da mesma forma descrita na 2ª etapa.

71

O presente estudo é orientado pelo Profª Leonardo Oliveira Pena Costa, em que será realizado pelo

aluno do curso de mestrado em Fisioterapia da Universidade Cidade de São Paulo, Patrícia do Carmo Silva Parreira.

Os pesquisadores garantem que não há riscos de qualquer natureza para os participantes. Você também tem a garantia de que terá acesso aos pesquisadores responsáveis para o esclarecimento de eventuais dúvidas. Se desejar, é garantida a liberdade da retirada de consentimento a qualquer momento e de deixar de participar do estudo. As informações obtidas serão analisadas em conjunto com as dos demais participantes, não sendo divulgada a identificação dos mesmos. Não há despesas pessoais para o participante em qualquer fase do estudo. Também não há compensação financeira relacionada à sua participação. Os pesquisadores se comprometem a utilizar os dados coletados somente para esta pesquisa.

Acredito ter sido suficientemente informado a respeito das informações que li ou que foram

lidas para mim, descrevendo o estudo. Ficaram claros para mim quais são os propósitos do estudo, seus desconfortos e riscos, as garantias de confidencialidade e de esclarecimentos. Concordo voluntariamente em participar desta pesquisa e poderei retirar o meu consentimento a qualquer momento, antes ou durante a mesma, sem penalidades ou prejuízo.

Eu,_____________________________________________________,RG:_______________________ _, do sexo ____________,nascido em ____/____/________,local:_______________________ residente à ____________________________________________________na cidade de _________________________________, declaro ter sido informado e estar devidamente esclarecido sobre os objetivos deste estudo sobre as técnicas e procedimentos e que estarei sendo submetido e sobre os riscos e desconfortos que poderão ocorrer. Recebi garantias de total de sigilo e de obter novos esclarecimentos sempre que desejar. Sei que minha participação esta isenta de despesas e que tenho direito a tratamento hospitalar (ou outro), se necessário. Assim, concordo em participar voluntariamente deste estudo e sei que posso retirar meu consentimento a qualquer momento, sem

nenhum prejuízo ou perda de qualquer beneficio (caso o sujeito de pesquisa esteja matriculado na Instituição onde a pesquisa está sendo realizada).

Data: ___/___/2012

___________________________

Assinatura do sujeito da pesquisa ou representante legal

72

COMITÊ DE ÉTICA EM PESQUISA

Pesquisador responsável / orientador

Eu, Leonardo Oliveira Pena Costa

Responsável pela pesquisa “Comparação de duas técnicas de Kinesio Taping em pacientes com dor lombar crônica não específica: um estudo controlado aleatorizado”, declaro que obtive espontaneamente o consentimento deste sujeito de pesquisa (ou de seu representante legal) para realizar este estudo.

Data:___/___/2012

___________________

Assinatura Pesquisador

DADOS DO PACIENTE

Informações gerais

Duração da dor lombar:____________________(Meses)

Idade_____ (anos) Data de nascimento:___/___/____ Gênero: Masculino Feminino

Estado civil: Solteiro Casado Divorciado Viúvo Outros

Peso (em quilos):___________ Altura (em metros):___________

Alfabetizado: Não Sim

Escolaridade completa: Fundamental Médio Superior Especialização

Mestrado Doutorado.

Profissão:_________________

Você utiliza algum medicamento para a dor lombar? Sim Não Qual?_____________

Você teve algum episódio de dor lombar recentemente? Sim Não

Você pratica alguma atividade física? Sim Não

73

Se sim, qual___________________ Há quanto tempo________ Frequência/Duração_________

Fumante? Sim Não

Dados para contato

Por favor escreva abaixo seus dados para contato:

Telefone residencial: __________Telefone celular: __________Telefone comercial: ____________

E-mail:____________________________________________________________________________

Endereço: Rua/Av________________________________________nº_______Complemento:_______

Bairro:________________________________Cidade:________________ CEP:__________________

Contato de um parente ou amigo

Para nos ajudar e entrar em contato com você caso você se mude de casa, por favor escreva os dados

de contato de um parente ou amigo seu que não more com você mas saiba para onde você vai mudar:

Nome do parente/amigo:___________________________________________

O que essa pessoa é sua:__________________________________________

Telefone residencial:____________Telefone celular:__________Telefone comercial:_____________

E-mail:__________________________________________________

74

Caracterização da dor e do quadro clínico do paciente

Linha de Base

Escala Numérica de Dor

Por favor classifique sua dor de 0 a 10 sendo 0 sem dor nenhuma e 10 a pior dor possível. Por favor, dê um número para descrever sua média de dor nos últimos sete dias.

75

Roland Morris Disability Questionnaire

Quando suas costas doem você pode achar difícil fazer coisas que normalmente fazia. Esta lista contém frases de pessoas descrevendo a si mesmas quando sentem dor nas costas. Você pode achar entre estas frases que você lê algumas que descrevem você hoje. À medida que você lê estas frases, pense em você hoje. Marque a sentença que descreve você hoje. Se a frase não descreve o que você sente, ignore-a e leia a seguinte. Lembre-se, só marque a frase se você tiver certeza que ela descreve você hoje.

1 Sim ( ) Não ( ) Fico em casa a maior parte do tempo por causa de minhas costas.2 Sim ( ) Não ( ) Mudo de posição frequentemente tentando deixar minhas costas

confortáveis.3 Sim ( ) Não ( ) Ando mais devagar que o habitual por causa de minhas costas.4 Sim ( ) Não ( ) Por causa de minhas costas eu não estou fazendo nenhum dos

trabalhos que geralmente faço em casa.5 Sim ( ) Não ( ) Por causa de minhas costas, eu uso um corrimão para subir

escadas.6 Sim ( ) Não ( ) Por causa de minhas costas, eu me deito para descansar

frequentemente.7 Sim ( ) Não ( ) Por causa de minhas costas, eu tenho que me apoiar em alguma

coisa para me levantar de uma cadeira normal. 8 Sim ( ) Não ( ) Por causa de minhas costas, tento conseguir com que outras

pessoas façam coisas por mim.9 Sim ( ) Não ( ) Eu me visto mais lentamente que o habitual por causa de minhas

costas. 10 Sim ( ) Não ( ) Eu fico de pé somente por períodos curtos de tempo, por causa de

minhas costas.11 Sim ( ) Não ( ) Por causa de minhas costas, eu evito me abaixar ou me ajoelhar.12 Sim ( ) Não ( ) Encontro dificuldades em me levantar de uma cadeira por causa

de minhas costas.13 Sim ( ) Não ( ) As minhas costas doem quase o tempo todo. 14 Sim ( ) Não ( ) Tenho dificuldade em me virar na cama por causa de minhas

costas.15 Sim ( ) Não ( ) Meu apetite não é bom por causa de dores em minhas costas.16 Sim ( ) Não ( ) Tenho problemas para colocar minhas meias (ou meia calça), por

causa das dores em minhas costas.17 Sim ( ) Não ( ) Caminho apenas curta distâncias por causa de dores em minhas

costas.18 Sim ( ) Não ( ) Não durmo tão bem por causa de minhas costas. 19 Sim ( ) Não ( ) Por causa de minhas costas, eu me visto com a ajuda de outras

pessoas.20 Sim ( ) Não ( ) Fico sentado a maior parte do dia por causa de minhas costas.21 Sim ( ) Não ( ) Evito trabalhos pesados em casa por causa de minhas costas.22 Sim ( ) Não ( ) Por causa de minhas dores nas costas, fico mais irritado e mal

humorado com as pessoas, do que o habitual. 23 Sim ( ) Não ( ) Por causa de minhas costas, eu subo escadas mais vagarosamente

do que o habitual.24 Sim ( ) Não ( ) Fico na cama a maior parte do tempo por causa de minhas costas.

Pontuação final:___

76

AVALIAÇÃO

APÓS 4 SEMANAS



Você recebeu algum outro tratamento, além da aplicação das bandagens, durantes as quatro semanas de terapia?

Não Sim Qual?_____________

77


78

AVALIAÇÃO

APÓS 3 MESES


Você recebeu algum outro tratamento, além da aplicação das bandagens, durantes as quatro semanas de terapia?

Não Sim Qual?_____________

Desde o término das aplicações das bandagens, você realizou algum outro tratamento?

Não Sim Qual?_____________

79


80

Capítulo 4

The use of convolutions in Kinesio Taping is not better than placebo in

patients with chronic non-specific low back pain: a randomised

controlled trial

81

Correspondence (for review):

Convolutions generated by the use Kinesio Taping are not better than placebo in

patients with chronic non-specific low back pain: a randomised controlled trial

Authors:

1. Patrícia do Carmo Silva Parreira, Masters and Doctoral Programs in Physical

Therapy, Universidade Cidade de São Paulo, Brazil. [email protected]

2. Lucíola da Cunha Menezes Costa, Masters and Doctoral Programs in Physical

Therapy, Universidade Cidade de São Paulo, Brazil. Musculoskeletal Division, The

George Institute for Global Health, Australia. [email protected]

3. Ricardo Takahashi, Private Physical Therapist, São Paulo, SP, Brazil.

[email protected]

4. Luiz Carlos Hespanhol Junior, Masters and Doctoral Programs in Physical Therapy,

Universidade Cidade de São Paulo, Brazil. Department of Public & Occupational

Health and EMGO+ Institute for Health and Care Research, VU University Medical

Center, Amsterdam, NH, The Netherlands. [email protected]

6. Maurício Antônio da Luz Junior, Masters and Doctoral Programs in Physical

Therapy, Universidade Cidade de São Paulo, Brazil. [email protected]

7. Tatiane Mota da Silva, Masters and Doctoral Programs in Physical Therapy,

Universidade Cidade de São Paulo, Brazil. [email protected]

8. Leonardo Oliveira Pena Costa, Masters and Doctoral Programs in Physical Therapy,

Universidade Cidade de São Paulo, Brazil. Musculoskeletal Division, The George

Institute for Global Health, Australia. [email protected]

82

Name Leonardo Oliveira Pena Costa

Department Masters and Doctoral Programs in Physical Therapy

Institution Universidade Cidade de São Paulo

Country Brazil

Tel +55 (11) 2178 1564

Mob +55(11) 98183 1550

Fax

Email [email protected]

Correspondence (for publication)

Abbreviated title: Kinesio Taping: a randomised controlled trial

Keywords: Kinesio Taping; randomised controlled trial; low back pain

Word Count: Abstract: 255 (Introduction, Method, Results, Discussion): 3486

References: 46

Tables: 2

Figures: 3

Ethics approval: Universidade Cidade de São Paulo Ethics Research Committee of

UNICID (number PP13603502)

Source(s) of support: Fundação de Amparo a Pesquisa do Estado de São Paulo

(FAPESP), and Conselho Nacional de Desenvolvimento Científico e Tecnológico

(CNPq), Brazil.

Trial registration: Brazilian Registry of Clinical Trials. Registration number: RBR-

7ggfkv

83

Name Leonardo Oliveira Pena CostaDepartment Masters and Doctoral Programs in Physical TherapyInstitution Universidade Cidade de São PauloCountry Brazil Email [email protected]

Abstract

Research Question: Is the application of the Kinesio Taping Method according to the

treatment manual (with convolutions in neutral position) more efficacious than a simple

application without convolutions in patients with chronic low back pain?

Study design: Prospectively registered, two-arm randomised placebo-controlled trial

with a blinded assessor.

Patients: 148 patients with chronic non-specific low back pain.

Intervention: 8 sessions of Kinesio Taping applied according to the Kinesio Taping

Method treatment manual (ie, 10–15% tension with convolutions in neutral). Control: 8

sessions of Kinesio Taping having no convolutions in neutral (0% tension).

Outcomes: The primary outcomes were pain intensity and disability after 4 weeks from

randomisation. Secondary outcomes were pain intensity, disability and global perceived

effect after 4 weeks and 3 months from randomisation.

Results: No between-group differences were observed for the primary outcomes of pain

intensity (mean difference= -0.4 points, 95% CI -1.3 to 0.4) or disability (mean

difference= -0.3 points, 95% CI -1.9 to 1.3). There was a small difference in favor of the

convolutions group for the secondary outcome of global perceived effect (mean

difference = 1.4 points, 95% CI 0.3 to -2.5) at 4 weeks. No between-group differences

were observed for all remaining secondary outcomes.

Conclusion: Applying Kinesio Taping under stretch to generate convolutions in the

skin was not more effective than the simple application of tension-free tape for the

outcomes measured. These results challenge the proposed mechanism of action of this

therapy.

Trial registration: Brazilian Registry of Clinical Trials (RBR-7ggfkv).

84

Background Chronic low back pain is a very prevalent condition (Hoyo et al 2013) and it is

associated with enormous health and socioeconomic costs (Dagenais et al 2008). The

prognosis (Costa et al 2012) of acute low back pain is initially favorable with reduction

of pain and disability in the first six weeks. After this period, there is slower

improvement in symptoms up to one year (Costa et al 2012). Several treatments are

available for patients with chronic low back pain. These treatments range from

educational programs (Engers et al 2008), medication (Deshpande et al 2007, Gagnier et

al 2006, Roelofs et al 2008), electrophysical agents (French et al 2006), manual therapy

(Assendelft et al 2004), exercises (Hayden et al 2005) and others (van Tulder et al

2006). Nevertheless, these treatments have, at best, a moderate effect size and new

treatments are needed to solve this problem (Airaksinen et al 2006, Delitto et al 2012).

Kinesio Taping (Kase et al 2003) is a new method of treatment that is very popular in

sports (Williams et al 2012) and it has been proposed for patients with low back pain

(Castro-Sanchez et al 2012, Paoloni et al 2011). This technique makes use of elastic

adhesive tape which is applied to the patient’s skin under tension (Kase et al 2003). The

elastic tape used with the technique can be extended up to 140% of its original length

(Kase et al 2003). The therapist decides during patient assessment which level of

tension will be used. The combination of the stretching capacity of the Kinesio Taping

with the muscle in a stretched position will create convolutions in the patients skin

(Kase et al 2003). These convolutions, according to the creators of this technique (Kase

et al 2003), reduce the pressure in the mechanoreceptors that are located below the

dermis, thereby decreasing nociceptive stimuli (Kase et al 2003). Furthermore, it has

been proposed that the convolutions alter the recruitment of muscles through inhibition

and excitation neuromuscular mechanisms (Kase et al 2003). Interestingly, the theory

85

that skin convolutions are the mechanism for the Kinesio Taping effects has never been

tested in a high quality randomised controlled trial.

Therefore, the research questions of this randomised controlled trial are:

1. Is the application of Kinesio Taping according to the treatment manual (ie, generating

convolutions in the skin by applying the Kinesio Tex Gold® Tape with a tension of 10–

15%) more efficacious than a simple ‘placebo’ application (ie, not generating

convolutions in the skin by applying the Kinesio Tex Gold® Tape without any tension)

in patients with chronic low back pain?

2. Can the effects observed after 4 weeks of treatment be sustained over 3 months after

randomisation?

Method

Design overview

This study is a prospectively registered, two-arm, randomised placebo-controlled trial

with a blinded assessor. The methods of the study were pre-specified in the published

protocol (Parreira et al 2013b).

Participants, therapists, centres

We included patients presenting with low back pain of at least three months’ duration,

aged between 18 and 80 years, of either gender, who were seeking treatment for low

back pain. Patients with any contraindication to physical exercise according to the

guidelines of the American College of Sports Medicine (Whaley et al 2006) patients

with serious spinal pathologies, nerve root compromise; serious cardiopulmonary

86

conditions; pregnancy; and patients with any contraindications to the use of taping (such

as skin allergy) were excluded from the study. All patients received a patch test before

randomisation to screen for any possible allergic reactions. Patients retained this patch

for 24 hours. Only patients who did not show any allergic reaction were randomised

into one of the treatment groups.

87

Baseline

Subjects screened (n= 184)

Excluded (n = 36) - Nerve root compromise (n = 11) - Other comorbidities (n = 10) - Refused to participate (n = 5) - Decompensated cardiovascular disease (n = 3) - Allergy to test of Kinesio Taping (n = 3) - Reported allergy to adhesive tape (n = 2) - Receiving physiotherapy treatment (n = 1) - Serious spinal pathology (n = 1)

Measured Pain, Disability and Global Perceived Effect

Randomised (n = 148)

(n = 74) (n = 74)

Lost to 4 weeks follow-up (n= 0)

Group with convolutions

n= 74

Group without convolutions

n= 74

Lost to 4 weeks follow-up (n= 0)

4 weeks Measured Pain, Disability and Global Perceived Effect

(n = 74) (n = 74)

Lost to 3 months follow-up (n= 0) Lost to 3 months

follow-up (n= 0)

3 months Measured Pain, Disability and Global Perceived Effect

(n= 74) (n= 74)

Figure 1. Design and flow of participants through the study.

88

Patients were treated by three physiotherapists who were not involved in patient

assessment. The physiotherapists were extensively trained to deliver the Kinesio Taping

intervention by two certified Kinesio Taping Method practitioners. These practitioners

audited the interventions over the course of the study. The trial was conducted in two

outpatient physiotherapy clinics in the cities of São Paulo and Campo Limpo Paulista,

Brazil.

Concealed allocation

Before starting treatment, patients were randomly assigned to their treatment groups

according to a randomisation scheme generated by computer and carried out by an

investigator who was not involved with the recruitment and treatment of participants.

The allocation of the subjects was concealed by using sequentially numbered, sealed

and opaque envelopes. On the first day of treatment, the envelope allocated to the

participant was opened by the physiotherapist who provided the treatments. This

physiotherapist was not involved with the data collection.

Intervention/control

148 patients were randomly allocated to receive two different approaches of Kinesio

Taping application.

1. Experimental group – patients were taped with an I-Shape Kinesio Tex Gold® Tape

over the erector spinae muscle with 10–15% of tension (also known as “paper-off”

tension) with the treated muscles in a flexed position and having skin convolutions

when the patient returns to the upright position according to the Kinesio Taping manual

(Kase et al 2003).

89

2. Control group – patients were taped with an I-Shape Kinesio® Tex Tape over the

erector spinae muscle without tension (no skin convolutions in the upright position)

with the treated muscles in standing position.

Patients from both groups received the treatments over 4 weeks (i.e. 8 treatment

sessions, twice a week, with a three day interval between the sessions). Patients were

instructed not to change their medication prescribed by their physician and not to seek

other treatment for their low back pain during the course of the study. Regular physical

activities were allowed, which were also monitored during the treatment sessions.

Kinesio Taping is an elastic adhesive tape that is applied to the patients' skin over the

area to be treated (Kase et al 2003). The tape is thin and light, and made of 100% cotton

fabric that is porous and does not restrict the range of motion. The tape is adhesive and

activated by heat, does not contain latex (hypoallergenic) and is reported to have similar

elasticity to the skin (Kase et al 2003). The elastic bandages can extend up to 140% of

its resting length (Kase et al 2003). The tapes can last a period of 3-5 days and can be

used in water. The expansion of the Kinesio® Tex Tape is only in the longitudinal

direction (Kase et al 2003).

For patients with low back pain, the bandages can be placed parallel to the spine or in an

asterisk format (Kase et al 2003). In this study the tape was placed over the erector

spinae muscles (bilaterally), parallel to the spinous processes of the lumbar vertebrae,

starting near the posterior superior iliac crest (Kase et al 2003, Parreira et al 2013b). The

experimental group was taped according to the Kenzo Kase’s Kinesio Taping Method

Manual (Kase et al 2003, Parreira et al 2013b) (Figure 2). These patients were taped

with I-Shaped Kinesio Tex Gold® Tape over the erector spinae muscles with 10–15%

90

Figure 2. I-Shape Kinesio Tex® Tape over the Erector Spinae muscle (2a) with 10–15%

of tension (paper-off tension) with the treated muscles in stretching position and having

convolutions in neutral.

of tension (paper-off tension) with the treated muscles in stretching position (2b– 2c)

according to the Kenzo Kase’s Kinesio taping manual (Parreira et al 2013b).

The control group received the taping without tension, first, by anchoring close to the

posterior superior iliac crest without traction (0% tension). Subsequently, patient was

asked to remain in the standing position and tape was applied until the end of the T8

vertebra. In this technique the therapist completely removed the tape backing paper in

order to remove the tension from the tape (Figure 3).

91

Figure 2a 2b 2c

Figure 3. I-Shape Kinesio Tex® Tape over the erector spinae muscle (3a) with no

tension (0% tension) and with the treated muscle in a non-stretched position (3b-3c)

(Parreira et al 2013b).

Patients were asked if the tape was limiting lumbar movement and in these cases, the

Kinesio Tex Gold® Tape was reapplied so that they had unrestricted range of motion.

Patients remained with the tape for two consecutive days. After this period, patients

were instructed to remove the tape, to clean the skin and to treat the skin with a

moisturising lotion. The patients went without tape for 24 hours to allow the skin to

recover appropriately and then patients returned to the clinic and the tape was reapplied.

This procedure was repeated eight times, over the course of four weeks.

Outcome measures

A total of three outcome measures were used: 1) Pain Numerical Rating Scale (NRS) to

determine the intensity of pain; 2) Roland Morris disability Questionnaire (RMDQ)

(Roland et al 1983) for the assessment of disability associated with back pain; and 3)

Global Perceived Effect Scale (GPE) (Fischer et al 1999) to evaluate the global

impression of recovery. The NRS, the RMDQ and the GPE have been properly

translated, cross-culturally adapted into Brazilian-Portuguese, and tested for their

measurement properties in patients with low back pain in Brazil (Costa et al 2008, Costa

Figure 3a 3b 3c

et al 2007, Nusbaum et al 2001). We also recorded any type of adverse effects that

might occur (such as allergic reactions or skin problems by asking the patient if he/she

had felt any itching or irritation on the skin where the tape was placed).

The primary outcomes were pain intensity and disability associated with low back pain

measured immediately after treatment (4 weeks).The secondary outcomes were pain

intensity and disability associated with low back pain measured 3 months after

randomisation and global impression of recovery measured immediately after treatment

(4 weeks) and 3 months after randomisation.

Numerical Pain Rating Scale (NRS) - The Numerical Pain Rating Scale (NRS) (Farrar

et al 2001) evaluates the levels of intensity of pain perceived by the patient using an 11-

point scale (ranging from 0 to 10), 0 being classified as "no pain" and 10 "worst

possible pain". Patients were asked to report the level of pain intensity based on the last

seven days. The data related to pain intensity was collected verbally, and if the patient

had difficulty to understand the question related to pain intensity the therapist showed

the scale in order to facilitate understanding.

Roland Morris Disability Questionnaire- The Roland Morris Disability Questionnaire

(RMDQ) (Roland et al 1983) is used to assess disability associated with back pain. It

consists of 24 items that describe common activities that patients have difficulty

performing due to back pain. The greater the number of alternatives checked by the

patient, the greater the level of disability. Patients were asked to fill in the items that

applied on the day the questionnaire was completed.

Global Perceived Effect Scale- The Global Perceived Effect Scale (Fischer et al 1999)

is an 11-point scale ranging from minus five (much worse), zero (no change) to plus

five points (completely recovered). For all measures of global perceived effect (at

93

baseline and at all follow-ups), participants were asked: "compared with the beginning

of the first episode how would you describe your lower back today?" A higher score

indicates better recovery. This scale has good measurement properties (Fischer et al

1999, Kamper et al 2010).

Despite being a condition with a high rate of absenteeism at work (Fisker et al 2013,

Waddell 2004) absenteeism-related data were not collected in this study.

Procedures

We recruited patients with chronic low back pain (with symptoms of at least 3 months’

duration) who were seeking care for their problem. Patients were screened by a

physiotherapist who was unaware of the treatment allocation in order to confirm

eligibility. This screening involves taking a careful medical history and a physical

examination. Eligible patients were informed about the study objectives and procedures

and if they agreed to participate in the study, they signed a consent form. The assessor

(who was blinded to the treatment allocation) then collected the baseline data and

performed the allergy test in all patients. Data collection included questions about

physical activity status and use of medication. This allergy test consisted of applying a

small Kinesio Tex Gold® Tape patch over the skin. Patients kept this patch on for 24

hours and were instructed to remove the patch and call the chief investigators if any

allergic reaction occurred. Eligible patients without allergic reaction to the patch test

were booked for randomisation and first treatment session.

Clinical outcomes were obtained in assessments that were performed by a blinded

assessor at 4 weeks and 3 months after randomisation. The 4-week follow up occurred

after the last day of treatment and the 3-month follow up was collected over the phone.

Patients were informed that they would receive one of two different forms of Kinesio

94

Taping application, but were blinded to the study hypotheses. Due to the nature of the

interventions it was not be possible to blind the therapists.

Sample size estimation

The study was designed to detect a between-group difference of 1 point in pain intensity

measured by the Pain Numerical Rating Scale, with an estimated standard deviation of

1.84 points and a between-group difference of 4 points for disability measured by the

Roland Morris Disability Questionnaire with an estimated standard deviation of 4.9

points. The specifications were: power of 80%, an alpha of 5% and a possible loss to

follow up of up to 15%. Therefore a total of 148 patients (74 patients per group) were

recruited for our study. The estimates used in our sample size calculation were lower

than the ones suggested as the minimum clinical important difference in order to

increase the precision of the effects of the interventions.

Data analysis

The statistical analysis was conducted on an intention to treat basis, i.e. the subjects

were analyzed in the groups they were allocated to. Visual inspection of histograms was

used to test data normality and all outcomes had normal distribution. The characteristics

of the participants were calculated through descriptive statistical tests. The between-

group differences and their respective 95% confidence intervals were calculated using

linear mixed models by using group, time and group versus time interaction terms.

Results We screened a total of 184 patients, and three patients were excluded due to unstable

heart disease, one patient was already receiving another type of treatment for low back

pain (conventional therapy), one patient was diagnosed with ankylosing spondylitis, 11

95

patients had nerve root compromise, 10 patients had other associated conditions (one

patient with piriformis syndrome, three patients undergoing cancer treatment, four

patients with sequelae of stroke, one patient with poliomyelitis and one with severe

osteoarthritis in the hip which limited flexion of the trunk). Besides these, two patients

reported being allergic to tape, three patients had allergic reactions to the Kinesio Tex

Gold® Tape in the allergy test and five patients had no interest in participating in the

study.

All 148 patients were evaluated at 4 weeks (after treatment) and 3 months (i.e., 0% loss

to follow up). Adherence to treatment was high in both groups (group "without

convolutions" with a mean of 7.14 sessions (SD = 1.91) of the planned eight sessions

and the group "with convolutions" with a mean of 7.43 sessions (SD = 1.48) of the

planned eight sessions.

Of the patients included in the study, only three did not attend all sessions of treatment

due to allergic reactions to the Kinesio Tex Gold® Tape, being one patient from the

group "with convolutions" and two patients from the group "without convolutions". All

participants recovered from the allergic reactions after the removal of the tape without

the need for additional interventions such as the use of antihistamines, for example.

The demographic characteristics and baseline values for the outcomes of this study are

shown in Table 1. The majority of participants were female (78%), with a mean age of

50 years, who had symptoms of pain for more than two years and had moderate levels

of pain intensity and disability. The groups were comparable at baseline.

96

Table 1. Demographic and clinical characteristics of the participants at baseline

(n=148).

Variables Intervention group

(with convolutions) Control group

(without convolutions) Gender

Female 56 (75.7) 59 (79.7) Male 18 (24.3) 15 (20.3)

Age (years) 50.7 (14.8) 49.9 (15.0) Duration of symptoms (months)* 24 (88) 36 (88) Weight (kilograms) 74.4 (14.2) 69.8 (10.7) Height (meters) 1.6 (0.1) 1.6 (0.1) Marital status

Single 10 (13.5) 16 (21.6) Married 51 (68.9) 42 (56.8) Widowed 5 (6.8) 9 (12.2) Divorced 8 (10.8) 7 (9.5)

Education status Elementary degree 25 (33.8) 18 (24.3) High school 34 (45.9) 37 (50.0) University 13 (17.6) 17 (23.0) Master’s degree 2 (2.7) 2 (2.7)

Use of medication (yes) 42 (56.8) 37 (50.0) Physically active (yes) 24 (32.4) 32 (43.2) Smoker (yes) 5 (6.8) 3 (4.1) Recent low back pain episode (yes) 39 (52.7) 42 (56.8) Pain intensity (0-10) 7.0 (2.0) 6.8 (2.0) Disability (0-24) 11.5 (6.2) 10.4 (5.3) Global Perceived Effect (-5 to 5) -1.0 (3.2) -0.14 (3.0) Categorical variables are expressed as number (%), continuous variables are expressed as mean (SD) *Duration of symptoms is expressed as median (interquartile range).

97

No between-group differences were observed for the primary outcomes of pain intensity

and disability in any of the assessments. There was a small difference in favor of the

intervention group for secondary outcome of global perceived effect at 4 weeks, but not

at three months. We also did not detect between group differences for all remaining

secondary outcomes (Table 2).

98

Table2:Valuesobtained(m

eanandstandarddeviation)atbaseline,post-treatmentand3m

onthsandtheirrespectivestandarddeviation,differenceswithinandbetw

eengroups,andtheir respective95%

confidenceintervalsfortheoutcomespainintensity,disabilityandglobalperceivedeffect.

Outcom

es

Baseline

4weeks

with

(n=74)

Painintensity

(0-10) D

isability (0-24)

Global

Perceived

Effect

(-5to5)

7.0

(2.0) 11.5

(6.2) -1.0

(3.2)

6.8

(2.0) 10.4

(5.3) -0.1

(3.0)

4.4

(2.8) 8.3

(6.9) 2.5

(2.4)

4.6(2.5)7.5

(6.4)1.9

(2.7)

5.4(2.4)8.8

(7.5)1.2

(2.8)

5.7(2.5)7.4

(6.7)1.6

(2.5)

without

(n=74) w

ith

without

(n=74)(n=74) w

ithw

ithout (n=74)(n=74)

with

2.6(2.0to3.3)

3.2(2.0to4.4)

-3.4(-4.3to-2.6)

without

2.2

(1.5to2.8) 2.9

(2.0to4.0) -2.1

(-2.9to-1.4)

with

1.6(1.0to2.2)

2.7(1.4to4.0)

-2.2(-3.0to-1.3)

4weeks

3months

Baselinem

inus

Groups

Within-groupdifferences

Adjustedbetw

een-groupdifferences

Baselinem

inus B

aselineminus

Baselinem

inus

3months

4weeks

3months

without

with-w

ithout w

ith-without

1.1(0.5to1.7)

3.0(1.9to4.1)

-1.6(-2.6to-0.9)

-0.4(-1.3to0.4)

-0.3(-1.9to1.3)

1.4(0.3to2.5)

-0.5

(-1.4to0.4) 0.3

(-1.3to1.9) 0.4

(-0.7to1.5)

with=

groupconvolutions,without=

groupwithoutconvolutions.C

ellsshadedingraycorrespondtotheprimaryoutcom

e

99

Discussion The objective of this randomised controlled trial was to compare the effectiveness of

two different ways of using the Kinesio Taping in patients with chronic non-specific

low back pain. After four weeks of treatment, both groups showed similar reductions in

pain intensity and disability (primary outcomes), with no statistically differences

between the two treatment conditions. One of the four secondary outcomes favored

patients allocated to the group "with convolution" with better results for the global

perceived effect outcome after 4 weeks of treatment compared with patients in group

"without convolutions."

The results of our trial are consistent with the results of two other trials that evaluated

the use of Kinesio Taping in patients with chronic low back pain. One study (Paoloni et

al 2011) allocated participants into three groups (Kinesio Taping and exercises, Kinesio

Taping only and exercises only). The outcomes assessed in this study were pain

intensity, disability, and lumbar muscle activation (measured by electromyography). No

between-group differences were observed. Another study (Castro-Sanchez et al 2012)

compared the effect of Kinesio Taping versus the control procedure of our trial (Kinesio

Taping without convolutions) for the outcomes pain, disability and range of motion for

flexion of the trunk. Patients received only one application of the tape remained for one

week. The authors also did not observe any difference in favor of the Kinesio Taping.

We are unaware of any studies that have evaluated the Kinesio Taping Method using the

global perceived effect scale.

There are five published systematic reviews (Bassett et al 2010, Kalron et al 2013,

Morris et al 2012, Mostafavifar et al 2012, Williams et al 2012) evaluating the

effectiveness of Kinesio Taping, being one specifically targeted on the treatment and

100

prevention of sports injuries (Williams et al 2012), two (Kalron et al 2013, Morris et al

2012) about different clinical conditions and two (Bassett et al 2010, Mostafavifar et al

2012) about musculoskeletal conditions. However, none of these reviews has found

clinical worthwhile benefits for this intervention. Our research group conducted the

most updated systematic review (Parreira et al 2013a) with a greater number of clinical

trials (Akbas et al 2011, Aytar et al 2011, Campolo et al 2013, Castro-Sanchez et al

2012, Djordjevic et al 2012, Evermann 2008, González-Iglesias et al 2009, Hsu et al

2009, Llopis et al 2012, Paoloni et al 2011, Saavedra-Hernandez et al 2012, Simsek et al

2013, Thelen et al 2008, Tsai et al 2010) relevant to musculoskeletal conditions. The

studies compared the Kinesio Taping with a range of treatments as well as with no

treatment and placebo. These studies were, on average, of moderate methodological

quality, with small sample sizes and very small follow-up periods. Regardless of the

comparison used (as well as the outcomes investigated), the results of clinical trials

conducted so far have shown no difference or found just a trivial effect in favor of

Kinesio Taping.

The results of our study challenge the importance of the presence of convolutions in

Kinesio Taping for effectiveness of treatment in patients with chronic low back pain.

According to the Method (Kase et al 2003), these convolutions increase blood and

lymphatic flow and aid in reducing pain in patients with musculoskeletal conditions.

According to the creators of the method applying proper tension is one of the key

factors for effective treatment (Kase et al 2003). However, the presence of convolutions

was not superior to the control group and so the improvement seen in both groups

cannot be due to tape tension. Probably the improvement observed in both groups

occurred due to a combination of tactile mechanisms, placebo effects and regression to

the mean. Although the use of the Kinesio Taping without convolutions can be

101

considered as an “imperfect” placebo, we are unaware of a better placebo that could be

used on this trial. The use of Kinesio Taping without convolutions has been used in

previous trials as a reasonable placebo (Castro-Sanchez et al 2012, González-Iglesias et

al 2009). The conclusion from our trial challenges the theory of convolutions as these

convolutions did not improve the outcomes in patients with low back pain.

Although some authors suggested an improvement of at least 20% to be considered as

clinically important (Bombardier et al 2001, Ostelo et al 2008), our sample size

calculation used a smaller difference (i.e. 1 point on an 11-point Pain NRS) in order to

increase the precision of our estimates. Both groups showed an improvement of 2 points

on the outcome pain intensity and 1 point in terms of disability. These results

corroborate with a meta-analysis on the prognosis (Costa et al 2012) of acute and

persistent low-back pain where patients typically improved 10-20% regardless the

treatment received by them.

To date this is the largest clinical trial ever conducted on the effectiveness of Kinesio

Taping. The study was performed without any deviations from our initial protocol

(Parreira et al 2013b). All patients who entered the study completed treatment and all

completed the follow-up assessments, contributing to unbiased treatment estimates. All

methodological steps were taken in order to provide the lowest risk of bias possible.

However due to the nature of the study, it was not possible to blind the therapist and

patients; and so can be seen as a limitation of our study. We also used the Kinesio Tex

Gold® Tape as this is the only brand recommended by the Kinesio Taping Association.

Therefore we are confident that the best and most updated intervention was provided to

the patients from this trial.

102

Based on the results of this study it can be concluded that there was no advantage of

using the Kinesio Taping using convolutions for the primary outcomes analysed. In

clinical practice, it is up to physiotherapists to inform and to discuss with their patients

the advantages and disadvantages of the method, taking into account costs as well as

patient preferences. We are unaware of any studies with patients with low back pain that

compare Kinesio Taping versus no treatment and it is worthwhile to perform such

investigation. Only one randomized trial compared Kinesio Taping versus no treatment

involving 20 participants with knee pain. The results showed that Kinesio Taping was

better than no treatment for patients with pain knee pain in the outcomes evaluated.

Nevertheless, the quality of this evidence of very low quality and more studies are

needed on this issue (Campolo et al 2013).

Our study is limited to the application of Kinesio Taping alone which may not reflect

the current clinical practice of many therapists. For future studies we believe that it

would be interesting to conduct studies involving using Kinesio Taping in addition to

treatments recommended by clinical practice guidelines (Airaksinen et al 2006, Delitto

et al 1995) for low back pain, such as manual therapy and exercises, for example. Our

research group has recently starting another randomised controlled trial in order to

respond to this research question (Added et al 2013).

Acknowledgements

This study was funded by the Fundação de Amparo à Pesquisa do Estado de São Paulo

(FAPESP-Brazil) and Conselho Nacional de Desenvolvimento Científico e Tecnológico

(CNPq-Brazil). Ms Parreira had her masters scholarship supported by FAPESP. Luiz

Carlos Hespanhol Junior is a PhD student supported by CAPES (Coordenação de

Aperfeiçoamento de Pessoal de Nível Superior), process number 0763-12-8, Ministry of

103

Education of Brazil. Leonardo Costa received a research productivity fellowship from

CNPq-Brazil to conduct a series of studies on the effectiveness of Kinesio Taping in

patients with musculoskeletal conditions. We would like to thank Professor Chris

Maher from The George Institute for Global Health, Australia for his insightful

comments prior to submission.

Registration / Protocol

This study design was approved by the Ethics Committee in Research of UNICID

(number PP13603502) and was also prospectively registered in the Brazilian Registry of

Clinical Trials (Registration number: RBR-7ggfkv). The research protocol was

published elsewhere (Parreira et al 2013b).

104

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108

Capítulo 5

Considerações finais

109

Considerações finais

Resultados encontrados

O ensaio clínico apresentado nesse exemplar de dissertação teve como objetivo

testar a eficácia de duas formas distintas do uso do Kinesio Taping (aplicando apenas

tensão da fita no papel sem nenhuma tensão externa aplicada pelo terapeuta não criando

circunvoluções na pele ou tracionando a bandagem gerando circunvoluções na pele) em

pacientes com dor lombar crônica não específica para os desfechos intensidade da dor,

incapacidade e percepção do efeito global. Após as quatro semanas de tratamento,

ambos os grupos apresentaram reduções similares da intensidade dor e incapacidade

(desfechos primários), não sendo observadas diferenças estatisticamente significantes

entre as duas condições de tratamento. Os pacientes que foram alocados no grupo “com

circunvoluções” apresentaram melhores resultados para o desfecho percepção do efeito

global após as 4 semanas de tratamento quando comparados com os pacientes do grupo

“sem circunvoluções”.

Esses resultados condizem com os resultados de dois outros estudos1,

2 que

utilizaram o Kinesio Taping para o tratamento de dor lombar crônica. Um1 dos estudos

comparou os efeitos de Kinesio Taping dividindo os participantes em três grupos,

(Kinesio Taping associado a exercícios, Kinesio Taping apenas e apenas exercícios). Os

desfechos avaliados nesse estudo foram intensidade da dor, incapacidade e ativação da

musculatura lombar (mensurados por eletromiografia). Não foram encontradas

diferenças entre os grupos. O outro estudo2 comparou o efeito do Kinesio Taping versus

placebo (Kinesio Taping sem circunvoluções) para os desfechos dor, incapacidade e

amplitude de movimento para flexão do tronco. Os pacientes foram submetidos a

apenas uma aplicação da bandagem permanecendo com a mesma por uma semana. Os

110

autores também não observaram diferenças entre os grupos. Não foram encontrados até

o momento estudos que avaliem o Método Kinesio Taping para o desfecho percepção

do efeito global.

Existem cinco3-7 revisões sistemáticas publicadas sobre a eficácia de Kinesio

Taping, sendo uma sobre tratamento e prevenção de lesões no esporte6, duas sobre

diversas condições clínicas4, 5 e duas sobre condições musculoesqueléticas3,

7. Contudo,

nenhuma encontrou benefícios clínicos para o tratamento. Nosso grupo realizou uma

revisão sistemática8 com um maior número de ensaios clínicos relevantes para

condições musculoesqueléticas com desfechos centrados no paciente, o que

consideramos mais importantes na prática clínica para profissionais da saúde e

pacientes. Os estudos elegíveis compararam o Kinesio Taping com uma grande

variedade de tratamentos (nenhum tratamento, placebo e outros tratamentos). Esses

estudos possuem qualidade metodológica moderada, com um reduzido número amostral

e avaliações pós-tratamento com tempo reduzido, que não permitem qualquer direção

terapêutica para fisioterapeutas e pacientes. Independentemente da comparação utilizada

(assim como os desfechos investigados), os resultados dos ensaios clínicos realizados

até o momento não mostraram nenhuma diferença ou encontraram um efeito muito

pequeno em favor do Kinesio Taping.

Os resultados do nosso ensaio clínico questionam a importância da presença das

circunvoluções no Kinesio Taping para efetividade do tratamento em pacientes com dor

lombar crônica. De acordo com o manual de tratamento, estas circunvoluções

aumentariam o fluxo sanguíneo e linfático e auxiliariam na redução da dor em pacientes

com condições musculoesqueléticas9. Segundo os criadores do método a aplicação da

tensão adequada é um dos fatores fundamentais para a efetividade do tratamento9.

Contudo, a presença das circunvoluções não demonstrou superioridade com o grupo

111

controle e provavelmente a melhora observada em ambos os grupos resultou da

combinação de mecanismos táteis, placebo e regressão para média. Os resultados

encontrados também reforçam a ideia de que a dor lombar crônica não específica está

altamente associada a fatores biopsicossociais, o que talvez explique um resultado

inexpressivo em um tratamento baseado apenas em mecanismos táteis. A conclusão que

se faz deste ensaio clínico é que as duas formas de utilização do Kinesio Taping para

pacientes com dor lombar crônica não específica auxiliam na melhora da dor e

incapacidade em curto prazo independente da forma que foi aplicada a bandagem no

paciente, ao contrário do que preconizam os criadores do método9.

Pontos fortes e limitações do estudo

Até o momento este é o maior ensaio clínico já realizado sobre Kinesio Taping.

O estudo transcorreu sem qualquer alteração do projeto inicial10. Todos os pacientes que

entraram no estudo terminaram os tratamentos e todos responderam as reavaliações.

Foram tomados cuidados metodológicos como randomização gerada por computador,

alocação secreta dos sujeitos, cegamento do avaliador e análise por intenção de tratar

para que o estudo tivesse o menor risco de viés. Porém devido à natureza do estudo, não

foi possível cegar o terapeuta e os pacientes que pode ser visto como uma limitação do

nosso estudo.

Implicações clínicas

Com base nos resultados desse estudo foi possível concluir que não houve

diferença estatisticamente significante e clinicamente importante entre os grupos nos

desfechos primários analisados. Na prática clínica, caberá aos fisioterapeutas informar e

discutir com seus pacientes as vantagens e desvantagens da aplicação do método,

levando em consideração custos assim como as preferências dos pacientes. A

112

interpretação dos autores de ambos estudos apresentados nesse exemplar de qualificação

é que o uso Kinesio Taping não possui suporte científico para o seu uso na prática

clínica.

Sugestões para novos estudos

Apesar dos conteúdos sobre o Kinesio Taping apresentados nessa dissertação

serem exclusivamente de natureza clínica, faz-se necessário que uma série de estudos

básicos de fisiologia e biomecânica sejam conduzidos. Esses estudos, de origem

laboratorial, poderiam oferecer um suporte científico mínimo necessário para um

melhor entendimento para os possíveis mecanismos de ação dessa intervenção.

Nosso estudo se limita a aplicação do Kinesio Taping sem qualquer outra terapia

associada, o que provavelmente não reflete a rotina clínica de muitos fisioterapeutas.

Para estudos futuros acreditamos que seria interessante a realização de estudos que

associem o Kinesio Taping a tratamentos recomendados pelas diretrizes de prática

clínica11,

12 para dor lombar. Outra sugestão é que sejam conduzidos estudos que considerem a realização de análises de subgrupo, para avaliar se existe algum perfil de

paciente que responderia melhor ao método. Nosso grupo iniciou um segundo estudo13

(em fase de recrutamento) com o objetivo de testar a eficácia da adição do método

Kinesio Taping a fisioterapia convencional em 148 pacientes com dor lombar crônica

não-específica nos desfechos intensidade da dor, incapacidade, percepção do efeito

global e satisfação com o atendimento. Finalmente, seria interessante saber se o Kinesio

Taping é melhor do que nenhum tratamento para pacientes com dor lombar crônica.

113

Referências

1. Paoloni M, Bernetti A, Fratocchi G, Mangone M, Parrinello L, Del Pilar Cooper M, et al. Kinesio Taping applied to lumbar muscles influences clinical and electromyographic characteristics in chronic low back pain patients. European Journal of Physical and Rehabilitation Medicine. 2011;47(2):237-44.

2. Castro-Sanchez AM, Lara-Palomo IC, Mataran-Penarrocha GA, Fernandez- Sanchez M, Sanchez-Labraca N, Arroyo-Morales M. Kinesio Taping reduces disability and pain slightly in chronic non-specific low back pain: a randomised trial. Journal of Physiotherapy. 2012;58(2):89-95. Epub 2012/05/23.

3. Mostafavifar M, Wertz J, Borchers J. A systematic review of the effectiveness of kinesio taping for musculoskeletal injury. The Physician and sportsmedicine. 2012;40(4):33-40. Epub 2013/01/12.

4. Morris D, Jones D, Ryan H, Ryan CG. The clinical effects of Kinesio Tex taping: A systematic review. Physiotherapy Theory and Practice. 2012;29(4):259-70. Epub 2012/10/24.

5. Kalron A, Bar-Sela S. A systematic review of the effectiveness of Kinesio Taping(R) - Fact or fashion? European Journal of Physical and Rehabilitation Medicine. 2013. Epub 2013/04/06.

6. Williams S, Whatman C, Hume PA, Sheerin K. Kinesio taping in treatment and prevention of sports injuries: a meta-analysis of the evidence for its effectiveness. Sports Medicine. 2012;42(2):153-64. Epub 2011/11/30.

7. Bassett K, Lingman S, Ellis R. The use and treatment efficacy of kinaesthetic taping for musculoskeletal conditions:a systematic review. New Zealand Journal of Physiotherapy. 2010;38(2):56-60.

8. Parreira P, Costa Lda C, Lopes AD, Hespanhol Junior LC, Costa LO. Current evidence does not support the use of Kinesio Taping in clinical practice: a systematic review. Journal of Physiotherapy. 2013.

9. Kase K, Wallis J, Kase T. Clinical Therapeutic Applications of the Kinesio Taping Method. Tokyo, Japan: Kení-kai information2003.

10. Parreira P, Costa Lda C, Takahashi R, Hespanhol Junior LC, Motta T, da Luz Junior MA, et al. Do convolutions in Kinesio Taping matter? Comparison of two Kinesio Taping approaches in patients with chronic non-specific low back pain: protocol of a randomised trial. Journal of Physiotherapy. 2013;59(1):52. Epub 2013/02/20.

11. Delitto A, Erhard RE, Bowling RW. A treatment-based classification approach to low back syndrome: identifying and staging patients for conservative treatment. Physical Therapy. 1995;75(6):470-85; discussion 85-9. Epub 1995/06/01.

12. Airaksinen O, Brox JI, Cedraschi C, Hildebrandt J, Klaber-Moffett J, Kovacs F, et al. Chapter 4. European guidelines for the management of chronic nonspecific low

back pain. European Spine Journal. 2006;15 Suppl 2:S192-300. Epub 2006/03/22.

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13. Added MA, Costa LOP, Costa LMC. Effectiveness of the Addition of the Kinesio Taping Method to Conventional Physical Therapy Treatment in Patients With Chronic Nonspecific Low Back Pain. 2013 [25/06/2013]; Available from: http://www.clinicaltrials.gov/ct2/show/NCT01866332?term=kinesiotaping&rank=2).

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Anexo 1

Instruções para os autores - Journal of Physiotherapy

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Anexo 1 - Instruções para os autores – Journal of Physiotherapy

Guidelines for clinical trials

Use the following headings and include the information outlined below:

Title

The title should contain the results of the intervention, the population, and the outcome,

followed by a colon and the design. For example:

Serial casting improves range of motion and walking after traumatic brain injury: a

randomised, placebo-controlled trial

Abstract

Question: State research question(s). Design: State randomisation, concealment,

blinding, and whether intention-to-treat analysis was done. Participants: Describe type

of participants and provide numbers and dropouts, and important inclusion criteria.

Intervention: Describe different interventions and their duration. Outcome measures:

State main outcome measures and frequency of measures. Results: State main effect of

intervention by giving size of effect and 95% CI (without p value). Conclusion: Give

brief conclusion and recommendation. Trial registration: State trial registration number.

Introduction

Write three paragraphs to explain why the trial was necessary. At the end of the

Introduction, state the research question(s) explicitly. For example:

Therefore the research questions for this study were, in stroke patients able to walk

independently:

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1. Does one month of treadmill training increase speed and capacity of walking,

improve quality of walking and decrease handicap? and

2. Are any gains maintained three months after the cessation of training?

Method

Design: Outline the design; in particular, state explicitly (i) whether the recruiter was

blinded to allocation sequence and whether the participants, treating investigator(s), and

the assessing investigator(s) were blind to group allocation; and (ii) how the group

allocation was concealed. State when: (i) intervention took place and (ii) outcome

measures were collected.

Participants, therapists, and centres: Outline the inclusion/exclusion criteria for

participants, therapists, and centres.

Intervention: Put as much detail in the description of the interventions as possible. Put

the experimental intervention first and then the control or alternative intervention.

Outcome measures: Distinguish the primary measure (1 only) from the secondary

measure(s). There should be only one primary outcome measure, which is the basis for

the power analysis. It is also useful to divide outcome measures into those examining

impairments vs activity limitations vs participation restrictions. Outline the

impairment/activity limitation/participation restriction being collected (eg, walking) and

its measurement procedure with units (eg, velocity during 10-m Walk Test in m/s).

Data analysis: Outline a priori power analysis of the number of participants needed for

the trial based on the minimum clinically-important difference set for the trial and the

population from which the SD was drawn. Outline any data calculation, eg, contracture

= intact side minus affected side. State which between-group differences will be

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presented as mean difference (95% CI) and which will be presented as odds

ratios/relative risk (95% CI).

State whether an intention-to-treat analysis was used.

Figures

Present a CONSORT-like figure that combines the design of the trial and the flow of

participants through the trial. For example, for a parallel-group design:

Only if a figure will add value to the text and tables, submit a composite figure of the

mean and SD of the primary outcome measures. Make the X-axis to scale rather than

just pre/post intervention. Provide a reasonable range of possibility on the Y-axis. Make

the experimental group the dominant symbols.

Tables

Tables are the best way of presenting the results. Put everything into tables so that the

findings can be used for future systematic reviews. There should be two types of tables,

one of the participant characteristics at baseline and one containing the outcomes at all

measurement times, the difference within groups and the difference between groups

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Anexo 2

Aprovação do Comitê de Ética e Pesquisa e Registro do estudo

120

06/08/13 AndamentodoProjeto

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portal2.saude.gov.br/sisnep/pesquisador/extrato_projeto.cfm?CODIGO=453022 1/1

Andamento do projeto - CAAE - 0072.0.186.000-11

Título do Projeto de Pesquisa

Comparação de duas técnicas de uso do Kinesio Taping em pacientes com dor lombar crônica não específica: um estudo controlado aleatorizado

Descrição Data Documento Nº do Doc Origem

4 - Protocolo Aprovado no CEP 22/08/2011 11:29:34 Folha de Rosto PP 13603502 CEP

2 - Recebimento de Protocolo pelo CEP (Check-List) 11/08/2011 16:08:25 Folha de Rosto 0070.0.186.000-11 CEP

3 - Recebimento de Protocolo pelo CEP (Check-List) 11/08/2011 16:10:43 Folha de Rosto 0072.0.186.000-11 CEP

1 - Envio da Folha de Rosto pela Internet 10/08/2011 11:48:56 Folha de Rosto FR453022 Pesquisador

Situação Data Inicial no CEP Data Final no CEP Data Inicial na CONEP Data Final na CONEP

Aprovado no CEP 11/08/2011 16:10:43 22/08/2011 11:29:34

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