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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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9
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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.
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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
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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
Kinesio Taping for musculoskeletal disorders Parreira Page 2 of 40
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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
Kinesio Taping for musculoskeletal disorders Parreira Page 3 of 40
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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
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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.
Kinesio Taping for musculoskeletal disorders Parreira Page 5 of 40
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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,
Kinesio Taping for musculoskeletal disorders Parreira Page 6 of 40
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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.
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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.
Kinesio Taping for musculoskeletal disorders Parreira Page 8 of 40
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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.
Kinesio Taping for musculoskeletal disorders Parreira Page 9 of 40
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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.
Kinesio Taping for musculoskeletal disorders Parreira Page 10 of 40
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
usculoskeletaldisorders P
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
usculoskeletaldisorders P
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
usculoskeletaldisorders P
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
Kinesio Taping for musculoskeletal disorders Parreira Page 15 of 40
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
usculoskeletaldisorders P
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.
Kinesio Taping for musculoskeletal disorders Parreira Page 17 of 40
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).
Kinesio Taping for musculoskeletal disorders Parreira Page 18 of 40
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
usculoskeletaldisorders P
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.
Kinesio Taping for musculoskeletal disorders Parreira Page 20 of 40
33
Table4.ResultsandconclusionsofstudiesofK
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%
CI0.2to1.7)infavourofK
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%
CI0.7to1.2)infavourofK
T
Gonzalez-
Iglesias 2009
neckpain
Pain(0to10):M
D1.1(95%
CI0.9to1.5)infavourofK
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
Tdidnotsignificantly
reducepainordisability.
KinesioTapingform
usculoskeletaldisorders P
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
I-1.0to1.2)infavourof
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
usculoskeletaldisorders P
arreira
Page22of40
35
Figure2.M
eandifferenceofKinesioTapingversussham
tapinginpatientswithm
usculoskeletalconditionsfortheoutcomespain(A
)and
disability(B).N
otethatnopoolingisconductedbecausetheclinicalconditionsoftheparticipantsdiffer.
A
KinesioTapingform
usculoskeletaldisorders P
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”.
Kinesio Taping for musculoskeletal disorders Parreira Page 24 of 40
37
Table5.ResultsandconclusionsofstudiesofK
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
Tdidnotsignificantly
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%
CI-1.7to2.5)infavourofK
T
Disability
b(0to24):MD
4.1(95%C
I-0.4to8.6)infavourof
exercises
Author:K
Tcannotsubstitutefor therapeuticexercises.
Review
:KT
didnotsignificantly
reducepainordisability
comparedtosupervised
exercises.
KinesioTapingform
usculoskeletaldisorders P
arreira
Page25of40
38
Saavedra-
Hernandez
2012
neckpain
Onew
eek
Pain(0to10):M
D0.2(95%
CI0.0to0.5)infavourofK
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
usculoskeletaldisorders P
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
Table6.ResultsandconclusionsofstudiesofK
inesioTapingplusotherinterventionversusotherinterventiononly(n=5).
Study
condition
Akbas2011
kneepain
After3w
kof K
Tplus
exercisesor exercisesonly
Tim
epoint R
esults
Pain(0to10)
atrest:MD
0.8(95%C
I-0.4to2.0)infavourofexercisesonly
sitting:MD
2.1(95%C
I0.4to3.8)infavourofexercisesonly
kneeling:MD
1.4(95%C
I-0.5to3.4)infavourofexercisesonly
walking:M
D1.8(95%
CI0.2to3.4)infavourofexercisesonly
squatting:MD
1.4(95%C
I-0.5to3.2)infavourofexercisesonly
ascstairs:MD
1.5(95%C
I-0.2to3.2)infavourofexercisesonly
descstairs:MD
1.4(95%C
I-0.5to3.4)infavourofexercises onlygoinguphill:M
D0.3(95%
CI-1.6to2.2)infavourofexercises
onlygoingdownhill:M
D1.1(95%
CI-0.9to3.0)infavourofexercises
only
Pain(0to10)
atrest:MD
0.9(95%C
I-0.2to2.0)infavourofexercisesonly
sitting:MD
1.8(95%C
I0.3to3.8)infavourofexercisesonly
kneeling:MD
0.3(95%C
I-1.5to3.4)infavourofexercisesonly
walking:M
D1.0(95%
CI-0.4to3.4)infavourofexercisesonly
squatting:MD
1.0(95%C
I-1.1to3.2)infavourofexercisesonly
ascstairs:MD
1.5(95%C
I0.0to3.2)infavourofexercisesonly
descstairs:MD
1.8(95%C
I-0.1to3.4)infavourofexercises only
After6w
kof K
Tplus
exercisesor exercisesonly
Conclusions
KinesioTapingform
usculoskeletaldisorders P
arreira
Page28of40
Author:A
ddingKT
to
conventionalexercises doesnotreducepainor disability.
Review
:AddingK
Tto
stretching,strengthening
andopenandclosed-chain
exercisesdoesnotreduce
painordisability.The
studyhadlow
methodologicalquality.
41
goinguphill:MD
0.5(95%C
I-0.9to2.2)infavourofexercises onlygoingdow
nhill:MD
1.4(95%C
I-0.3to3.0)infavourofexercises onlyD
isabilitya(0to100):M
D0.4(95%
CI-5.2to6.1)infavourofK
T
plusexercises
Llopis2012
neckpain
Onew
eekafter the6-w
eekKT
plususualcare
orusualcare
onlytreatment
periodsended
Pain(0to10)neck:M
D1.6(95%
CI-0.8to3.9)infavourofK
T
plususualcare
Pain(0to10)arm
:MD
2.2(95%C
I-0.7to5.2)infavourofKT
plus usualcare
Qualityoflife
b(0to100)
Generalhealth:M
D8.4(95%
CI-7.7to24.5)infavourofK
Tplus
usualcare
Socialrole:M
D5.00(95%
CI-35.8to45.7)infavourofK
Tplus
usualcare
Physical:M
D7.5(95%
CI-19.2to34.2)infavourofK
Tplus
usualcare
Bodilypain:M
D1.40(95%
CI-9.9to23.8)infavourofK
Tplus
usualcare
Vitality:M
D7.0(95%
CI-9.6to23.6)infavourofK
Tplususual
careEm
otionalRole:M
D5.0(95%
CI-6.5to16.5)infavourofK
T
plususualcare
Author:A
ddingKT
to
physiotherapytreatments
improvestheireffects.
Review
:AddingK
Tto
stretching,mobilityand
strengtheningexercises andm
assagedoesnot reducepainorim
prove
qualityoflife.Thestudy
hadlowm
ethodological quality.
KinesioTapingform
usculoskeletaldisorders P
arreira
Page29of40
42
Paolini
2011
lowback
pain
Atcom
pletion
of4wkofK
T
plusexercisesor exercisesonly
Mentalhealth:M
D9.6(95%
CI-0.5to19.7)infavourofK
Tplus
usualcare
Pain(0to10):M
D0.2(95%
CI-1.8to2.2)infavourofK
Tplus
exercisesD
isabilityc(0to24):M
D1.9(95%
CI-1.1to4.9)infavourofK
T
plusexercises
Sim
sek
2013
shoulder pain
After12daysof
KT
plus exercisesor sham
KT
plus exercises
KinesioTapingform
usculoskeletaldisorders P
arreira
Page30of40
After5daysof
KT
plus exercisesor sham
KT
plus exercises
Pain(0to10)
atrest:MD
0.9(95%C
I-0.7to2.5)infavourofKT
plusexercises
atnight:MD
2.0(95%C
I0.0to4.1)infavourofKT
plus exercises
onactivity:MD
1.8(95%C
I0.5to3.2)infavourofKT
plus exercisesD
isabilityd(0to100):M
D18(95%
CI6to30)infavourofK
Tplus
exercises
Pain(0to10)
atrest:MD
1.2(95%C
I-0.4to2.8)infavourofKT
plusexercises
atnight:MD
2.5(95%C
I0.4to4.5)infavourofKT
plus exercises
onactivity:MD
2.0(95%C
I0.4to3.4)infavourofKT
plus exercisesD
isabilityd(0to100):M
D22(95%
CI10to34)infavourofK
Tplus
exercises
Author:K
Tm
aybeused
inadditiontotherapeutic exercisesasashort-term
strategy.
Review
:AddingK
Tto
relaxation,stretchingand
activeexercisesdoesnot reducepainordisability.
Author:A
ddingKT
to
exercisesismoreeffective
thanexercisesalone.
Review
:AddingK
Tto
stabilisationandmobility
exercisesimprovespain
anddisability.Thestudy
hadlowm
ethodological quality.
43
Tsai2010
Onew
eekafter P
ain:Thenum
berofwordschosentodescribethepainonapain
A
uthor:AddingK
Tto
theKT
plus characteristicsquestionnaire
ewastakenasam
easureofpain
electrotherapymight
footpain
electrotherapy
intensity.Significantlyfew
erwordsw
ereusedtodescribethepain
alleviatepainmorethan
or afterK
Tpluselectrotherapythanafterelectrotherapyalone:M
D8
electrotherapyalone. electrotherapy
(95%
CI6to9)infavourofK
Tpluselectrotherapy.
Review
:AddingK
Tto
only
Disability
f(0to100) electrotherapym
ayreduce
pain,butthemeasureof
atworst:M
D24(95%
CI15to34)infavourofK
Tplus
paindidnotreflectpain
electrotherapyintensityw
ellandthere
morning:M
D30(95%
CI18to42)infavourofK
Tplus
wasam
arkeddifferencein
electrotherapybaselinepainbetw
eenthe
evening:MD
26(95%C
I14to38)infavourofKT
plus groups.A
ddingKT
to
electrotherapyelectrotherapyreduces
walkbarefoot:M
D5(95%
CI-6to16)infavourofK
Tplus
disability.Thestudyhad
electrotherapy
lowm
ethodological quality.
standbarefoot:MD
14(95%C
I2to27)infavourofKT
plus electrotherapy
walkshod:M
D16(95%
CI5to27)infavourofK
Tplus
electrotherapy
standshod:MD
21(95%C
I7to35)infavourofKT
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
DisabilityQ
uestionnaire,dDisabilitiesoftheA
rm,S
houlder&H
andQuestionnaire,eM
cGillM
elzackPainQ
uestionnaire,fFootF
unction
Index,MD
=M
eanDifference
.
KinesioTapingform
usculoskeletaldisorders P
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.
Kinesio Taping for musculoskeletal disorders Parreira Page 32 of 40
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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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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selected functional impairments of the musculoligament apparatus) [German]. Komplementare und Integrative Medizin 49: 32–36.
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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 &
Sports Physical Therapy 39: 515–521.
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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Kase K, Wallis J, Kase T (2003) Clinical Therapeutic Applications of the Kinesio Taping Method. Tokyo, Japan: Kení-kai Co Ltd.
Llopis GL, Aranda CM (2012) Physiotherapy intervention with kinesio taping in patients suffering chronic neck pain. A pilot study. Fisioterapia 34: 189–195.
Macedo LG, Elkins MR, Maher CG, Moseley AM, Herbert RD, Sherrington C (2012) There was evidence of convergent and construct validity of Physiotherapy Evidence Database quality scale for physiotherapy trials. Journal of Clinical Epidemiology 63: 920–925.
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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
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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$.mp. 28 follow?up.mp.
Kinesio Taping for musculoskeletal disorders Parreira Page 38 of 40
51
29 placebo$.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
Kinesio Taping for musculoskeletal disorders Parreira Page 39 of 40
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
Kinesio Taping for musculoskeletal disorders Parreira Page 40 of 40
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
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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
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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
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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%
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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.
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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
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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
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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
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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.
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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.
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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
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.
Roland Morris Disability Questionnaire
Você recebeu algum outro tratamento, além da aplicação das bandagens, durantes as quatro semanas de terapia?
Não Sim Qual?_____________
77
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:___
78
AVALIAÇÃO
APÓS 3 MESES
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.
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
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:___
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.
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
92
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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Parreira P, Costa Lda C, Lopes AD, Hespanhol Junior LC, Costa LO (2013a) Current evidence does not support the use of Kinesio Taping in clinical practice: a systematic review. Journal of Physiotherapy.
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Parreira P, Costa Lda C, Takahashi R, Hespanhol Junior LC, Motta T, da Luz Junior MA, Costa LOP, Cook J (2013b) 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.
Roelofs PD, Deyo RA, Koes BW, Scholten RJ, van Tulder MW (2008) Non-steroidal anti-inflammatory drugs for low back pain. Cochrane Database of Systematic Review: CD000396.
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.
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.
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 journal 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.
van Tulder M, Becker A, Bekkering T, Breen A, del Real MT, Hutchinson A, Koes B, Laerum E, Malmivaara A (2006) Chapter 3. European guidelines for the management of acute nonspecific low back pain in primary care. European Spine Journal 15 Suppl 2: S169-191.
Whaley MH, Brubaker PH, Otto RM (2006) ACSM's Guidelines For Exercise Testing And Prescription (7th edn edn).
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.
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Capítulo 5
Considerações finais
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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
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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
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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
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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
116
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:
117
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
118
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
119
Anexo 2
Aprovação do Comitê de Ética e Pesquisa e Registro do estudo
120
121
06/08/13 AndamentodoProjeto
122
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