campo eletromagnético pulsado e exercícios no tratamento da
TRANSCRIPT
DIEGO GALACE DE FREITAS
CAMPO ELETROMAGNÉTICO PULSADO E EXERCÍCIOS NO TRATAMENTO DA SÍNDROME
DO IMPACTO DO OMBRO: ENSAIO CLÍNICO ALEATÓRIO, PLACEBO-CONTROLADO
Tese apresentada ao Curso de Pós Graduação da Faculdade de Ciências Médicas da Santa Casa de São Paulo para obtenção do Titulo de Doutor em Ciências da Saúde.
SÃO PAULO 2013
2
DIEGO GALACE DE FREITAS
CAMPO ELETROMAGNÉTICO PULSADO E EXERCÍCIOS NO TRATAMENTO DA SÍNDROME
DO IMPACTO DO OMBRO: ENSAIO CLÍNICO ALEATÓRIO, PLACEBO-CONTROLADO
Tese apresentada ao Curso de Pós Graduação da Faculdade de Ciências Médicas da Santa Casa de São Paulo para obtenção do Titulo de Doutor em Ciências da Saúde. Área de concentração: Ciências da Saúde Orientadora: Profa. Dra. Patrícia Maria de Moraes Barros Fucs
SÃO PAULO 2013
FICHA CATALOGRÁFICA
Preparada pela Biblioteca Central da Faculdade de Ciências Médicas da Santa Casa de São Paulo
Freitas, Diego Galace de Campo electromagnético pulsado e exercícios no tratamento da síndrome do impacto do ombro: ensaio clínico aleatório, placebo-controlado./ Diego Galace de Freitas. São Paulo, 2013.
Tese de Doutorado. Faculdade de Ciências Médicas da Santa Casa de São Paulo – Curso de Pós-Graduação em Ciências da Saúde.
Área de Concentração: Ciências da Saúde Orientadora: Patrícia Maria de Moraes Barros Fucs 1. Síndrome de colisão de ombro 2. Campos eletromagnéticos 3.
Modalidades de fisioterapia 4. Terapia por exercícios/métodos 5. Diatermia 6. Bainha rotadora
BC-FCMSCSP/70-13
DEDICATÓRIA
Dedico aos meus pais, pelo incansável apoio e incentivo, que com carinho e amor iluminaram meu caminho. A minha esposa e sogra que sempre com inspiração e
carinho me apóiam em todos os momentos mais difíceis, a todos que torcem e me apóiam o tempo todo. Ao meu irmão que ensina a viver através de sonhos.
Agradeço a DEUS a benção e o privilégio de tê-los em minha vida.
"Emprega maior tempo no aperfeiçoamento de ti mesmo, e nenhum tempo em criticar os outros"
(Carlos Gracie)
AGRADECIMENTOS
À Irmandade da Santa Casa de Misericórdia de São Paulo, pela infra-
estrutura para realização desse trabalho.
À Faculdade de Ciências Médicas da Santa Casa de São Paulo, que
possibilitou o desenvolvimento dessa pesquisa.
À orientadora Profa. Dra. Patrícia Fucs, minha gratidão pelas horas dedicadas
à orientação desta pesquisa.
Ao Prof. Dr. Thiago Fukuda, que mesmo a distância me ajudou nos momentos
difíceis além de ser um amigo apto a me ouvir e ver o quanto a profissão de docente
é importante para formação do ser humano.
A Profa. Dra. Nilza Carvalho, que sempre acreditou em mim, me ensinou o
verdadeiro valor do humanismo, compreensão do ser humano e como coordenar
com harmonia os problemas. A Sandra com seu amor e atenção.
Ao Renan Monteiro, exemplo de ser humano, que me ensinou ver a pesquisa
como algo agradável, sendo responsável por estimular em mim a usar a razão e
mediar os meus conflitos na busca do equilíbrio.
Ao Marco Aurélio, que com sua vontade de gerar o bem me estimula cada dia
a estudar e promover o novo.
Aos meus amigos de trabalho da ISCMSP, os quais eu admirava como
professores e me formaram o profissional que sou e hoje tenho como parceiros de
discussão e me aprimoram a cada dia o meu ver do mundo.
Aos meus “tios” Marcio e Vitor Tosi por ensinar valorizar a minha pessoa e a
profissão, onde no “Ying Yang” vejo a explicação do amor entre os dois que
transmitem a todos que estão ao seu lado.
À minha família Fisioterapia (especializandos e colegas) pela generosidade,
apoio diário e a oportunidade privilegiada de conviver com pessoas especiais, que
deixam marcas profundas de amizade.
Agradeço os queridos amigos Mirtes Souza, Daniel Gomes e Sonia Regina
que compartilharam comigo os sucessos e insucessos desta trajetória
A todos os amigos que participaram da formação do meu caráter, e me
ensinaram a crescer nas dificuldades e viver cada dia apoiando o próximo.
Agradeço especialmente aos pacientes, pois sem eles nada disto seria
possível.
Abreviaturas e Símbolos
CIEC - Coeficientes de Correlação Intraclasse
CEMP - Campo Eletrico Magnético Pulsado
EVA - Escala Visual Analógica
G - Gauss
Hz - Hertz
ICC - Indice de Correlação de Confiança
mT - MiliTesla
Kg - Quilogramas
RNM - Ressonância Nuclear Magnética
SIO - Síndrome de Impacto do Ombro
USG - Ultra-Sonográfia
JARCET - The Journal of Applied Research
APMR - Archives of Physical Medicine and Rehabilitation
SUMÁRIO
___________________________________________________________________
1- INTRODUÇÃO................................................................................................. 1
2- OBJETIVOS..................................................................................................... 4
3- MÉTODOS ..................................................................................................... 6
3.1 – Artigo 1 :
Campo eletromagnético pulsado e exercícios em pacientes com síndrome do
impacto do ombro: ensaio clínico controlado.
3.1.1 Texto enviado para publicação para JARCET, versão em
português.................... 7
3.2.2 Texto enviado para publicação para JARCET, versão em inglês.........19
3.2 – Artigo 2 :
Campo eletromagnético pulsado em pacientes com síndrome do impacto do
ombro: em estudo duplo-cego, randomizado controlado.
3.2.1 Texto enviado para publicação para APMR, versão em
português....................32
3.2.2 Texto enviado para publicação para APMR, versão em inglês............ 56
4- CONSIDERAÇÕES FINAIS............................................................................ 76
5- REFERÊNCIAS BIBLIOGRÁFICAS................................................................ 78
6- FONTES CONSULTADAS.............................................................................. 81
7- ANEXOS........................................................................................................ 83
7.1 – Anexo 1: Email de aceite JARCET........................................................ 84
7.2 – Anexo 2: Email de submissão APMR ................................................... 85
7.3 – Anexo 3: Autorização Comitê de Ética.................................................. 86
7.4 – Anexo 4: Carta de solicitação de troca de titulo CEP........................... 87
7.5 – Anexo 5: Normas das Revistas............................................................. 88
7.5.1 - The Journal of Applied Research....................................................... 88
7.5.2 - Archives of Physical Medicine and Rehabilitation............................. 90
1. INTRODUÇÃO
2
1. INTRODUÇÃO
O biomagnetismo surgiu após a descoberta de Michael Faraday, no final de
1700. Em seguida, o médico e físico Luigi Galvani mostrou, em patas de sapo,
a íntima conexão entre a corrente elétrica e a contração muscular. Anos
depois, Alessandro Volta trouxe à tona uma polêmica a respeito dos
experimentos de Galvani, afirmando que os eletrodos geravam os campos
elétricos e não os tecidos musculares. Hoje em dia, sabe-se que cada um tinha
sua parcela de razão1.
No ano 850 a.C. iniciaram-se as descobertas a respeito da ação dos
campos eletromagnéticos (CEM) no corpo humano2 e se define biomagnetismo
como o estudo da interação entre os CEM e sistemas biológicos3.
Torna-se de vital importância o conhecimento aprofundado a respeito da
fisiologia do eletromagnetismo no corpo humano, porém, os CEM são utilizados
para tratamento de ampla rede de patologias. Nesta revisão separaremos, por
razões didáticas, a fisiologia eletromagnética por patologias e efeitos
fisiológicos gerais.
Nas últimas duas décadas descobriu-se uma variedade de efeitos
fisiológicos gerados pelos campos magnéticos atérmicos4, e entre os principais
destacam-se: estímulo da produção de condrócitos e proteoglicanos5, aumento
do efeito piezoelétrico, produção de colágeno6, neo-angiogenese, estímulo do
fluxo de anions e cátions7, revascularização e angiogênese4. Recentemente
apresentaram-se na literatura evidências de que os CEM possuem efeitos
satisfatórios no tratamento de patologias do sistema músculo-esquelético5.
A síndrome de impacto do ombro (SIO) afeta aproximadamente 20% da
população, com aumento da prevalência ao longo do envelhecimento8,9.
Inicialmente descrita por Neer, a SIO apresenta clara relação entre compressão
das estruturas subacromiais, fraqueza e degeneração do manguito rotador10,11.
O campo eletromagnético pulsado (CEMP) baseia-se no estudo da
interação dos campos eletromagnéticos não-ionizantes e sistemas biológicos,
isto é, ―bioeletromagnetismo‖12,13. No espectro de baixa frequência
eletromagnética (abaixo de 300 Hz), estudos experimentais sugerem efeitos
3
terapêuticos em várias condições patológicas, como pseudoartrose14,
osteoartrite15, dor aguda e crônica de diferentes condições músculo-
esqueléticas16, lesões tendíneas e aceleração de cura17,18. Além destes, outros
autores sugerem a hipótese de que os efeitos do tratamento CEMP
provavelmente estão relacionados ao aumento da atividade celular local,
orientação de fibras de colágeno, aumentando o teor de oxigênio ao tecido,
vasodilatação dos vasos sanguíneos sem aumento da temperatura
local16,19,20,21.
O manejo primário da SIO é representada pelo tratamento conservador,
baseado em medicamentos, exercícios terapêuticos e aplicação de agentes
físicos. O uso desses agentes com objetivos analgésicos e anti-inflamatórios é
muito comum na prática clínica, visando evitar ou reduzir os efeitos
secundários causados por medicamentos, pois o uso desses fármacos implica
risco crescente de desordens gastrointestinais ou cardiovasculares22,23,24.
No entanto, a eficácia da CEMP para tratar problemas de ombro
permanece ainda controversa. Alguns ensaios clínicos demonstram resultados
positivos19, mas outros não apresentam os mesmos efeitos8,25.
Por isto, este estudo demonstra a necessidade da compreensão da
influência do CEMP em alterações biológicas e na abordagem especifica de
patologias, no caso a SIO.
4
2. OBJETIVOS
5
2. Objetivos
Avaliar os efeitos de campo eletromagnético pulsado (CEMP) e exercícios
na redução da dor, melhora da força muscular e a função em pacientes com
síndrome de impacto do ombro (SIO)
6
3. MÉTODOS
7
3. Métodos
3.1 Artigo 1: Campo eletromagnético pulsado e exercícios em pacientes
com síndrome de impacto do ombro: Ensaio clínico controlado.
3.1.1. Texto enviando para publicação JARCET , versão em
português.
CAMPO ELETROMAGNÉTICO PULSADO E EXERCÍCIOS EM PACIENTES
COM SÍNDROME DE IMPACTO DO OMBRO: ENSAIO CLÍNICO
CONTROLADO.
Diego Galace de Freitas (PT, MSc)1, Renan Monteiro de Lima (PT, candidato MSc)1, Freddy Beretta Marcondes (PT, candidato MSc)1 , Katrin Fenzl (PT)1, Karen Vantin (PT) 1, Thiago Yukio Fukuda (PT, PhD) 1, Patrícia Maria de Moraes Barros Fucs (MD, PhD)2
1. Fisioterapia Sector, Irmandade da Santa Casa de Misericórdia (ISCMSP), São Paulo, Brasil; 2. Ortopedia e Traumatologia no departamento, Irmandade da Santa Casa de Misericórdia (ISCMSP), São Paulo, Brasil;
8
RESUMO
ESTUDO: Duplo-cego, randomizado controlado.
INTRODUÇÃO: Estudos recentes mostram que um programa do campo de eletromagnético pulsado (CEMP) é indicado para distúrbios músculo-esqueléticos. No entanto, existem poucos estudos clínicos para avaliar os resultados deste tipo de programa para a síndrome do impacto do ombro (SIO).
OBJETIVOS: Avaliar os efeitos do CEMP na redução da dor, melhora da força muscular e função em pacientes com SIO.
MÉTODOS: Cinquenta e seis pacientes foram recrutados, com idades entre 40 e 59 anos, diagnosticados com SIO. Os participantes foram aleatoriamente divididos em dois grupos: grupo CEMP (n = 26, média de idade de 50,77 anos) e o grupo Placebo (n = 30, média de idade de 50,15 anos). As variáveis do questionário UCLA, escala de constante Murley, Escala Visual Analógica (EVA), amplitude de movimento de rotação interna, externa e elevação, e força muscular dos músculos rotadores internos e externos foram mensurados.
RESULTADOS: Ao final do tratamento, ambos os grupos apresentaram melhora em todas as variáveis, quando comparadas aos valores basais. Mudanças ao longo do tempo na UCLA, constante-Murley e EVA não foram diferentes entre o grupo CEMP e placebo.
CONCLUSÃO: O CEMP foi eficaz no alívio da dor e função de pacientes com SIO. Houve ligeira melhora da dor em ambos os grupos, após a aplicação do CEMP e Placebo, com diferença estatisticamente significativa entre os grupos, que sugeriu que houve efeito placebo.
NÍVEL DE EVIDÊNCIA: terapia, nível 1ª.
PALAVRAS-CHAVE: CEMP, diatermia, magnetoterapia, manguito rotador
9
INTRODUÇÃO
A SIO é a causa mais comum de dor no ombro em adultos (Imhoff et al.,
2004; Jerosch et al.; 2002; Neer.; 1972). Pode ser observada entre 7 e 25
clínicos gerais em cada mil consultas. A prevalência em pacientes abaixo dos
70 anos é cerca de 7% a 27%; acima dessa idade pode variar entre 13% e
26%. É a terceira maior causa de perturbações dolorosas do sistema músculo-
esquelético, mantendo-se atrás apenas das dores da coluna e do joelho (Van
der Windt et al.;1995; Luime et al., 2004).
Essa patologia é geralmente caracterizada por dor na região ântero-
lateral do ombro e face lateral do braço (Fodor et al, 2009). A maioria dos
pacientes se queixa de dor noturna e dificuldade para deitar sobre o ombro
afetado (Ostor et al.;2005).
Várias intervenções são utilizadas no tratamento da SIO, como uso de
fármacos, cirurgias e fisioterapia (Rabini et al; 2012; Haahr et al.; 2005). No
entanto, há pouca evidência para apoiar a eficácia dessas aplicações
terapêuticas em dor no ombro (Akta et al, 2007). Recurso muito utilizado na
prática clínica são os campos eletromagnéticos pulsados (CEMP). O CEMP é
indicado para o tratamento de distúrbios músculo-esqueléticos (Tashjian et al,
2009), agindo diretamente na redução da dor e no processo de regeneração de
tecidos moles, musculares, tendinosos e principalmente tecidos ósseo e
nervoso. No entanto, não há consenso na literatura sobre os parâmetros a
serem utilizados no tratamento da dor no ombro (Leclaire et al.;1991, Markov et
al.; 2007) e pouca evidência de seus efeitos (Quittan et al., 2000, Green et al.;
1998, Aktas et al.; 2009).
O objetivo deste estudo é avaliar os efeitos da CEMP na força muscular,
função e dor em pacientes com SIO. Formulamos a hipótese de que o grupo
que recebe o CEMP demonstraria resultados significativamente melhores
quando comparados com placebo CEMP.
10
MATERIAIS E MÉTODOS
Trata-se de ensaio placebo-controlado, randomizado e duplo-cego,
executado no setor de fisioterapia da Irmandade Santa Casa de Misericórdia de
São Paulo (ISCMSP), de abril de 2009 a agosto de 2011, em pacientes com
SIO. O estudo foi previamente aprovado pelo Comitê de Ética da instituição,
sob o protocolo número 254/09 e registrado no clinicaltrials.gov (número de
registo: NCT01452204).
A amostra do estudo foi selecionada a partir de pré-lista com sessenta e
seis pacientes do Departamento de Reabilitação em Ombro da ISCMSP. O
cálculo amostral para este estudo foi baseado na detecção de 30% de melhora
no desfecho intensidade da dor, mensurado por meio da Escala Visual
Analógica (EVA), com poder estatístico de 80%, com nível de significância de
5% (Bang et al., 2000). Foram necessários 24 indivíduos por grupo, em um
total de 48 participantes.
O diagnóstico da patologia baseou-se na história, exame clínico e de
imagem (ultrassonografia e raio-x). Fizeram parte do estudo indivíduos de
ambos os sexos, com idade entre 35 e 67 anos. Os participantes recrutados
foram diagnosticados com SIO unilateral, com grau I ou II da moléstia, de
acordo com os critérios de Neer (Neer; 1983) e sintomas acima de 3 meses.
Foram excluídos da amostras participantes que receberam tratamento
fisioterapêutico nos 60 dias anteriores, que estavam em uso de anti-
inflamatórios não esteroides (AINEs) via oral ou por infiltração, mulheres
grávidas, indivíduos com história de câncer ou procedimento cirúrgico no
ombro afetado, artropatias inflamatórias (artrite reumatoide, lúpus, gota etc.),
cervicobraquialgia ou síndrome da dor regional complexa.
Os indivíduos foram randomizados por meio de sorteio com envelope
selado e opaco, contendo o nome dos dois grupos: CEMP - tratamento com
PEMF e o grupo Placebo - Placebo (equipamento em stand by).
O equipamento de campo eletromagnético utilizado foi da marca
Magnetherp ® 330 Meditea, fabricado em 2007, com forma pulsada
11
previamente calibrada com frequência de 50 Hz e campo de força de 20
militesla (mT) ou 200 Gauss.
Todos os sujeitos foram submetidos a nove sessões, três vezes por
semana, com intervalo de 48 horas entre as sessões. O tempo de cada
aplicação foi de 30 minutos, e os eletrodos foram posicionados na técnica
contraplanar.
AVALIAÇÃO
Todos os pacientes selecionados para o estudo foram submetidos a uma
avaliação pré-tratamento em relação a força muscular, função e dor. O mesmo
procedimento foi realizado após as 3 semanas de tratamento do campo
eletromagnético pulsado (avaliação de post CEMP). Todas as avaliações foram
feitas por um examinador cego em relação à alocação dos indivíduos. Os
sujeitos da pesquisa desconheciam a comparação com outro grupo.
Dor e função
A Escala Visual Analógica (EVA) foi utilizada para mensurar dor, e a
escala de constante-Murley (Constante et al.;1987) e da Universidade da
Califórnia em Los Angeles, ombro Rating escala - UCLA (Ellman et al; 1986),
foram usadas para avaliar a funcionalidade.
Força muscular
A mensuração da força do manguito rotador (rotação interna e externa) e
elevação do ombro ocorreu com um dinamômetro manual marca Lafayette ® -
modelo 01163.
Para mensuração da força dos rotadores internos e externos, o indivíduo
foi posicionado em supino, com o ombro abduzido a 45°, e 30° de adução
horizontal (plano escapular), o cotovelo fletido a 90° e rotação neutra
(MacDermid et al; 2004, Kuhlman et al., 1992), com o dinamômetro
posicionado no pulso.
12
Para a avaliação da força durante a elevação do ombro, o indivíduo foi
mantido na posição de sedestação, com abdução de ombro de 45°, adução
horizontal de 30°, rotação neutra e cotovelo estendido. O dinamômetro foi
posicionado na superfície dorsal do pulso. Foi dado comando para os pacientes
realizarem contração isométrica máxima em todas as posições. Todas as
mensurações ocorreram três vezes, usando a média das três medidas.
Teste intraclasse (ICC) encontrou valores satisfatórios para a avaliação
dos rotadores internos (ICC = 0,50), excelente para avaliação dos rotadores
externos (ICC = 0,93) e elevação (ICC = 0,88).
Análise dos dados
Os dados foram analisados com o programa SPSS, versão 13.0 (SPSS
Inc, Chicago, IL. -USA). Análise estatística descritiva aconteceu para a
demografia, e todas as mensurações dos resultados expressos como média e
desvio padrão, seguido por intervalo de confiança (IC) de 95%. Comparações
de idade, altura, peso, dor, escalas de funcionalidade, mensuração da força
muscular e homogeneidade dos grupos na linha de base (pré-tratamento)
foram feitas pelo teste-t independente. Os resultados para mensuração da dor
(EVA), escalas funcionais (UCLA e constante) e força muscular foram
analisados usando o teste-t pareado. A significância estatística foi considerada
quando (p < 0,05).
RESULTADOS
Linha de base e dados demográficos
Na análise pré-tratamento, os grupos apresentaram homogeneidade
para idade, altura e peso corporal (p <. 05). Não houve diferença estatística (p
<. 05) entre os grupos para as variáveis estudadas na linha de base (antes da
intervenção).
13
Cinquenta e seis pacientes iniciaram o tratamento; no entanto, 4 destes
não fizeram as avaliações finais por causa da falta de regularidade ou
abandono do tratamento, sendo automaticamente excluídos (Figura 1).
Força muscular, função e dor
A comparação entre os grupos não apresentou diferenças
estatisticamente significativas (p <. 05) para dor, força muscular e
funcionalidade em todas as escalas.
A análise pré e pós-intervenção indicou que o grupo CEMP mostrou
melhora na dor e na função após a aplicação (< p 0,05). No entanto, o grupo de
placebo mostrou resultados favoráveis nos níveis de dor (p < 0,05).
A tabela 3 resume a diferença intragrupo com associação do intervalo de
confiança de 95%.
Análise de intenção de tratar
A perda na amostra de 4 participantes durante o estudo (Post-PEMF)
não afetou a validade do mesmo, pois os abandonos não excederam 10% do
total dos participantes, pois se exigia análise de intenção de tratar.
DISCUSSÃO
Este estudo teve como objetivo avaliar os efeitos do campo
eletromagnético pulsado na SIO. Os resultados deste estudo prospectivo,
randomizado, duplo-cego, mostraram que o uso do CEMP é eficaz para
melhora de função e alívio de dor. Estima-se que o MCID da EVA na patologia
do ombro é definida como diminuição nos níveis de dor a 1,4 centímetros
(Tashjian et al., 2009). Observou-se que ambos os grupos melhoraram nos
níveis de dor, com melhora clínica significativa de 1.7 para o grupo CEMP e 2,0
cm para o grupo de placebo. Para a avaliação funcional usando os
questionários constante e UCLA, o CEMP alcançou resultados significativos
em ambas as escalas, enquanto o grupo placebo não apresentou melhora na
função.
14
Aktas et al. (2007) desenvolveram um estudo que usou o CEMP como
conduta auxiliar no tratamento da SIO. Os resultados mostraram que o uso
combinado de CEMP e o exercício para o SIO em comparação ao grupo
placebo não diferiram para a dor e a função. Nossos resultados corroboram
estudos anteriores, geralmente encontrados na literatura. Sutbeyaz et al.
(2006) observaram que o CEMP é eficaz para o tratamento da osteoartrose
cervical; foram observadas redução da dor e melhora na amplitude de
movimento. No entanto, em relação ao grupo placebo, tais resultados não
apresentam diferenças significativas.
As variações em parâmetros usados no CEMP impedem o consenso.
Sugere-se que outros estudos com diferentes modulações de frequência e
intensidade da CEMP sejam feitos para avaliar os efeitos de diferentes
calibrações em indivíduos com SIO.
CONCLUSÃO
O CEMP provou ser eficaz na melhoria da função e dor em indivíduos
com SIO. No entanto, a CEMP não obteve diferenças significativas em relação
ao grupo placebo em todas as variáveis do estudo.
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al. Prevalence and incidence of shoulder pain in the general population: a
systematic review. Scand J Clauw DJ, 2004; 33: 73-81
6- Fodor D , Poanta L , 1st Felea , Rednic S , Bolosiu H . Shoulder
impingement syndrome: correlations between clinical tests and
ultrasonographic findings. Ortop Traumatol Rehabil. 2009; 11: 120-6.
7- Ostor AJ, Richards CA, Prevost AT, AC, Speed Hazlemen BL. Diagnosis and
relation to general health of shoulder disorders presenting to primary care.
Rheumatology. 2005; 44: 800-5.
8- Rabini, Piazzini DB, Bertolini C, L Deriu, Saccomanno Santagada, MF, et al.
Effects of Local Microwave Diathermy on Shoulder Pain and Function in
Patients With Rotator Cuff Tendinopathy Subacromial Corticosteroid Injections
to in Comparison: A Single-Blind Randomized Trial J Orthop Sports Phys Ther
2012; 42 (4): 363-370.
9- Haahr JP, Ostergaard, Dalsgaard J., Norup K, Frost P, Lausen S, Holm And
Andersen. Exercises arthroscopic decompression versus in patients with
subacromial impingement: a randomised, controlled study in 90 cases with a
one year follow up. Ann Rheum Dis 2005; 64: 760-764.
10- Aktas I, K, Akgun Cakmak b. Therapeutic effect of pulsed electromagnetic
field in conservative treatment of subacromial impingement syndrome. Clin
Clauw Dj. 2007: 26: 1234-1239.
11- Tashjian R.Z.; Deloach J.; Porucznik , C. A,; Powell, A.M.; Minimal clinically
important differences (MCID) and patient acceptable symptomatic state (PASS)
for visual analog scales (VAS) measuring pain in patients treated for rotator cuff
disease; Journal of Shoulder and Elbow Surgery, 18, (6); 927-32; 2009
16
12- Leclaire R.; Bourgouin J.. Electromagnetic treatment of periarthritis
shoulder: a randomized controlled trial of the efficiency and tolerance of
magnetotherapy. Archives of Physical Medicine and Rehabilitation; 72 (5): 284-
287; 1991
13- Markov Ms. Pulsed electromagnetic field therapy history, state of the art and
future. Environmentalist 2007; 27: 465-75.
14- Quittan M, Schuhfried, Wiesinger GF, Fialka-Moser v. Clinical effectiveness
of magnetic field therapy — a review of the literature. Acta Med Austriaca, 2000,
27: 61-68.
15- Green S, Buchbinder R, Glazier R, Forbes a. Systematic review of
randomised controlled trials of interventions for painful shoulder. BMJ 1998,
316: 354-360.
16- Bang MD , GD Deyle. Comparison of supervised exercise with and without
manual physical therapy for patients with shoulder impingement syndrome. J
Orthop Sports Phys Ther. 2000 Mar; 30 (3): 126-37.
17- Neer CS 2nd. Impingement lesions. Clin Orthop Res. 1983 Report: 70-7.
18- Constant CR, Murley MB. The clinical method of functional assessment of
the shoulder. Clin Orthop. 1987; 214: 160-4.
19- Ellman H, Hanker G, Bayer m. Repair of the rotator cuff. J Bone Joint Surg
am. 1986; 68: 1136-44.
20- MacDermid JC, Ramos J, Drosdowech D, Faber K, Patterson S. The impact
of rotator cuff pathology on isometric and isokinetic strength, function, and
quality of life. J Shoulder Elbow Surg. 2004; 13: 593-98.
21- Kuhlman JR, Iannotti JP, Kelly MJ, et al. measurement of isometric and
Isokinetic strength of external rotation and abduction of the shoulder. J Bone
Joint Surg Am. 1992; 74: 1320-33.
17
22- Sutbeyaz ST, Sezer N, Koseoglu BF. The effect of pulsed electromagnetic
fields in the treatment of cervical osteoarthritis: a randomized, double-blind,
sham-controlled Trial. Clauw DJ int. 2006; 26: 320-324.
Figura 1:
Tabela 1:
18
Tabela 2:
19
3.1.2. Texto enviando para publicação JARCET , versão em inglês.
PULSED ELECTROMAGNETIC FIELD IN PATIENTS WITH SHOULDER
IMPINGEMENT SYNDROME
Diego Galace de Freitas (PT, MSc)1, Renan Lima Monteiro (PT, MSc candidate)1, Freddy Beretta Marcondes (PT, MSc candidate)1 , Katrin Fenzl (PT)1, Karen Vantin(PT) 1, Thiago Yukio Fukuda (PT, PhD) 1, Patrícia Maria de Moraes Barros Fucs (MD, PhD)2
1.Physical Therapy Sector, Irmandade da Santa Casa de Misericordia (ISCMSP), São Paulo, Brazil
2.Orthopaedic and Traumatology Department, Irmandade da Santa Casa de Misericordia (ISCMSP), São Paulo, Brazil
20
SUMMARY
STUDY: Double-blind, randomized controlled trial.
OBJECTIVES: Evaluate the effects of pulsed electromagnetic field (PEMF) in reducing pain, improve function and muscle strength in patients with shoulder impingement syndrome (SIS).
INTRODUCTION: Recent studies show that a PEMF based program has been indicated for musculoskeletal disorders. However, there are few clinical studies to evaluate the results of this type of program for SIS.
METHODS: Fifty-six patients were recruited, aged between 40 and 59 years, diagnosed with SIS. The participants were divided into two groups: PEMF (n = 26, average age of 50.77 years) and Placebo Group (n = 30, ages of 50.15 years). The variables UCLA, scale of constant Murley, EVA and internal and external rotation and shoulder elevation muscle strength were used.
RESULTS: At the end of treatment, both groups showed improvements in all outcome measures in relation to baseline values. Changes over time at UCLA, Constant-Murley and EVA were not different between PEMF and placebo group.
CONCLUSION: The PEMF was effective in improving the function of the shoulder and pain relief in patients with SIS. There was a slight improvement of pain in both groups, after the application of PEMF and Placebo, with no statistically significant difference between the groups, which suggested there was a placebo effect.
Level of evidence: Therapy, level 1A
KEYWORDS: PEMF, Diathermy, magnetotherapy, rotator cuff
21
INTRODUCTION
Shoulder impact syndrome (SIS) is the most common cause of shoulder
pain in adults (Imhoff et al., 2004; Jerosch et al.; 2002; Neer.; 1972). It is
observed between 7 and 25 in every 1000 consultations with general clinicians.
It´s prevalence in patients under 70 years is about 7 to 27%, and above this age
it varies between 13.2 to 26% and is the third most pain cause in
musculoskeletal disorders being only behind the spine and knee pain (Van der
Windt et al.;1995; Luime et al., 2004).
The mains characteristic of the disease is pain, usually located in the
anterolateral region of the shoulder and the lateral aspect of the arm (Fodor et
al.; 2009). Most patients complain of night pain and difficulty to lie down on the
affected shoulder (Ostor et al.;2005).
Several interventions have been used on the treatment of the SIS, which
include the use of medications, surgery and physiotherapy (Rabini et al.; 2012;
Haahr et al.; 2005).
However, there is little evidence supporting the effectiveness of these
therapeutic applications on shoulder pain (Akta et al.; 2007), among them, the
use of Pulsed Electromagnetic Fields (PEMF).
The PEMF is indicated for the treatment of musculoskeletal disorders
(Tashjian et al.; 2009), reduction of pain, accelerating process of soft tissue
regeneration, muscular, tendinous and mostly bone and nerve tissues. However
there is no consensus in the literature about the parameters to be used in the
treatment of shoulder pain (Leclaire et al.;1991) (Markov et al.; 2007) and little
22
evidence for its positive effects (Quittan et al., 2000; Green et al.; 1998; Aktas et
al.; 2009).
Thus, the objective of this study was to evaluate the effects of PEMF in
pain, function and muscle strength in patients with impingement syndrome of
shoulder. We hypothesized that the group that receives the PEMF would
demonstrate significantly better results when compared to placebo PEMF.
MATERIALS AND METHODS
This prospective, randomized, placebo-controlled, double blind was
executed in the sector of physiotherapy of the Irmandade Santa Casa de
Misericórdia de São Paulo (ISCMSP) from April 2009 to August 2011 in patients
with SIS. The study was approved in advance by the Ethics Committee of the
institution, under the protocol number 254/09 and registered at clinicaltrials.gov
(registration number: NCT01452204).
The study sample was selected from a list of patients of the rehabilitation
of the shoulder department of the ISCMSP and was made of sixty-six
individuals. The sample size was calculated assuming an 80% power to detect
30% improvement in pain scores (Visual Analog Scale-EVA), with a significance
level of 5% across the study by Bang (Bang et al., 2000) and resulted in a
sample of 24 individuals per group.
The diagnosis was based on history, clinical examination and ultrasound
imaging. The study subjects were of both genders, aged between 35 and 67
years and diagnosed with unilateral shoulder impingement syndrome grades I
23
or II, according to criteria of Neer (Neer; 1983) with symptoms over 3 months.
Exclusion criteria: non-steroidal anti-inflammatory drugs (NSAIDs) orally or by
infiltration, physical therapy treatment within the past 60 days, pregnant
women, subjects with a history of cancer or surgical procedure in the affected
shoulder. Were also excluded patients with inflammatory joint diseases
(rheumatoid arthritis, lupus, gout, etc), cervicobraquialgia or complex regional
pain syndrome. During the screening, all individuals who made use of the
medications cited previously interrupted the use seven days prior to starting
treatment.
Individuals were randomized through a raffle with an opaque sealed
envelope containing the name of the two groups: PEMF - treatment with PEMF
and the Placebo group - Placebo (equipment in "stand by").
The electromagnetic field equipment used was Magnetherp ® 330
Meditea brand, manufactured in 2007, with a previously calibrated pulsed form
with a frequency of 50 Hz and field strength of 20 millitesla (mT) or 200 Gauss.
All subjects underwent nine sessions, three times a week with a 48-hour
interval. The time of each application was 30 minutes, and the electrodes were
positioned in the contraplanar technique.
EVALUATION
All patients selected for the study underwent a pretreatment assessment
about pain, function and muscle strength. This same procedure was performed
after the 3 weeks of pulsed electromagnetic field (PEMF post evaluation)
24
treatment. All these evaluations were performed by a single blind examiner
regarding the allocation of individuals. The research subjects were unaware that
there was comparison with another group.
Pain and function
The Visual analogue scale of pain (EVA) was used to evaluate the pain,
and the Constant-Murley scale (Constant et al.;1987) and the University of
California at Los Angeles Shoulder Rating Scale - UCLA (Ellman et al.; 1986)
were used to evaluate the functionality.
Muscular strength
The measurement of the strength of the rotator cuff (internal and external
rotation) and elevation of the shoulder was performed with a brand manual
dynamometer Lafayette ®- model 01163.
To measure the internal and external rotators strength, the subject was
positioned in supine, with the shoulder abducted to 45° and with 30° of
horizontal adduction (scapular plane), the elbow flexed at 90° and neutral
rotation (MacDermid et al.; 2004, Kuhlman et al.; 1992) , with the dynamometer
positioned on the wrist.
For the evaluation of strength during the elevation of the shoulder, the
subject was kept in a sitting position, with a 45° shoulder abduction, 30°
horizontal adduction, neutral rotation and extended elbow. The dynamometer
was positioned on the dorsal surface of the wrist. It was required for the patients
to perform maximum isometric contraction in all positions. All measurements
were performed three times using the average of the three measurements.
25
Intra-class test (ICC) found satisfactory values for assessment of the
medial rotators (ICC = 0.50), excellent for evaluation of lateral rotators (ICC =
0.93) and elevation (ICC = 0.88).
Analysis of the data
Data were analyzed with the SPSS program, version 13.0 (SPSS Inc,
Chicago, IL. USES). Descriptive statistical analysis was performed to the
demographics and all measurements of results being expressed as mean and
standard deviation, followed by confidence interval (CI) of 95%. Comparisons of
age, body mass, height, weight, pain scales, scales to determine muscle
strength and functional homogeneity of the groups at baseline (pre-treatment)
were performed by the independent t test. The results for the pain scales (EVA),
functional scales (UCLA and Constant), and muscle strength were analyzed
using paired t-test. The statistical significance was considered when (p < 0.05).
RESULTS
Baseline and demographic data
In the pre-treatment analysis the groups presented homogeneity for age,
height and body weight (p <. 05). There was also no statistical difference (p <.
05) between the groups for the studied variables at baseline (before
intervention).
26
Fifty-six patients started treatment, however 4 patients did not reach final
assessments due to lack of proper conduct or abandonment of the treatment,
and were automatically excluded (Figure 1).
Pain, function and muscle strength
The comparison between the groups did not show statistically significant
differences (p <. 05) for pain, muscle strength and functionality in all scales.
The analysis of pre-and post-intervention indicated that the active group
showed improvement in pain and function after the application of PEMF (< p
0.05). However, the placebo group showed only improvements in the levels of
pain (p < 0.05).
Table 3 summarizes the difference within the same group with
association of the 95% confidence interval.
Intention-to-treat analysis
Sample loss of 4 participants during the study (Post-PEMF) did not affect
the potential validity of the study because this dropout did not exceed 10% of
the total, which required an intention-to-treat analysis.
DISCUSSION
This study aimed to assess the effects of pulsating electromagnetic field
in the SIS. The results of this prospective, randomized, double-blind trial
showed that the use of PEMF is effective for pain relief and function
improvement.
27
It is estimated that the VAS MCID in shoulder pathology is defined as a
decrease in the levels of pain to 1.4 centimeters (Tashjian et al., 2009). It was
observed that both groups improved in pain levels, with a significant clinical
improvement of 1.7 for the PEMF group and 2.0 cm for the placebo PEMF
group. For the functional assessment using Constant and UCLA, the PEMF
group achieved significant improvements in both scales, while the placebo
group did not show improvements in function.
Meanwhile, Aktas (Aktas et al., 2007), conducted a study that used the
PEMF as auxiliary conduct in the treatment of SIS. The results showed that the
combined use of PEMF and exercise for SIS compared to the placebo group did
not differ for the pain and function. Our results corroborate previous studies
generally found in the literature. Sutbeyaz et al. (2006), observed that the PEMF
is effective for the treatment of cervical osteoarthritis, pain reduction and
improvement in range of motion, however, compared to the placebo group such
results do not have significant differences.
The variations in parameters used in PEMF, hinder a consensus. It is
suggested that further studies with different frequency and intensity modulations
of PEMF are made to evaluate the effects of different calibrations in individuals
with SIS.
CONCLUSION
28
The PEMF proved to be effective in improving function and pain in
individuals with SIS. However the PEMF did not obtain significant differences
compared to the placebo group in all variables of the study.
REFERENCES
1- Imhoff, Ledermann t. pathologische Befunde und Pathogenese Definition. In:
Eulert J, Hedtmann A, editors. The Impingement syndromder Schulter.
Stuttgart: Thieme; 1996. p. 1-13.
2- Jerosch J, Wustner p. Effect of the sensorimotor training program on patients
with subacromial pain syndrome [in german]. Unfallchirurg 2002; 105: 36-43.
3- Neer cs. acromioplasty for the chronic Anterior impingement syndrome in the
shoulder: a preliminary report. J Bone Joint Surg am. 1972; 54: 41-50.
4- Van der Windt DA, Koes BW, Bouter LM, de Jong. Shoulder disorders in
general practice: incidence, patient characteristics, and management. Ann
Rheum Dis 1995; 54: 959-64
5- Luime JJ, Koes BW, Hendriksen IJ, Burdorf, Verhagen AP, Miedema HS, et
al. Prevalence and incidence of shoulder pain in the general population: a
systematic review. Scand J Clauw DJ, 2004; 33: 73-81
6- Fodor D , Poanta L , 1st Felea , Rednic S , Bolosiu H . Shoulder
impingement syndrome: correlations between clinical tests and
ultrasonographic findings. Ortop Traumatol Rehabil. 2009; 11: 120-6.
7- Ostor AJ, Richards CA, Prevost AT, AC, Speed Hazlemen BL. Diagnosis and
relation to general health of shoulder disorders presenting to primary care.
Rheumatology. 2005; 44: 800-5.
8- Rabini, Piazzini DB, Bertolini C, L Deriu, Saccomanno Santagada, MF, et al.
Effects of Local Microwave Diathermy on Shoulder Pain and Function in
Patients With Rotator Cuff Tendinopathy Subacromial Corticosteroid Injections
to in Comparison: A Single-Blind Randomized Trial J Orthop Sports Phys Ther
2012; 42 (4): 363-370.
9- Haahr JP, Ostergaard, Dalsgaard J., Norup K, Frost P, Lausen S, Holm And
Andersen. Exercises arthroscopic decompression versus in patients with
29
subacromial impingement: a randomised, controlled study in 90 cases with a
one year follow up. Ann Rheum Dis 2005; 64: 760-764.
10- Aktas I, K, Akgun Cakmak b. Therapeutic effect of pulsed electromagnetic
field in conservative treatment of subacromial impingement syndrome. Clin
Clauw Dj. 2007: 26: 1234-1239.
11- Tashjian R.Z.; Deloach J.; Porucznik , C. A,; Powell, A.M.; Minimal clinically
important differences (MCID) and patient acceptable symptomatic state (PASS)
for visual analog scales (VAS) measuring pain in patients treated for rotator cuff
disease; Journal of Shoulder and Elbow Surgery, 18, (6); 927-32; 2009
12- Leclaire R.; Bourgouin J.. Electromagnetic treatment of periarthritis
shoulder: a randomized controlled trial of the efficiency and tolerance of
magnetotherapy. Archives of Physical Medicine and Rehabilitation; 72 (5): 284-
287; 1991
13- Markov Ms. Pulsed electromagnetic field therapy history, state of the art and
future. Environmentalist 2007; 27: 465-75.
14- Quittan M, Schuhfried, Wiesinger GF, Fialka-Moser v. Clinical effectiveness
of magnetic field therapy — a review of the literature. Acta Med Austriaca, 2000,
27: 61-68.
15- Green S, Buchbinder R, Glazier R, Forbes a. Systematic review of
randomised controlled trials of interventions for painful shoulder. BMJ 1998,
316: 354-360.
16- Bang MD, GD Deyle. Comparison of supervised exercise with and without
manual physical therapy for patients with shoulder impingement syndrome. J
Orthop Sports Phys Ther. 2000 Mar; 30 (3): 126-37.
17- Neer CS 2nd. Impingement lesions. Clin Orthop Res. 1983 Report: 70-7.
18- Constant CR, Murley MB. The clinical method of functional assessment of
the shoulder. Clin Orthop. 1987; 214: 160-4.
19- Ellman H, Hanker G, Bayer m. Repair of the rotator cuff. J Bone Joint Surg
am. 1986; 68: 1136-44.
20- MacDermid JC, Ramos J, Drosdowech D, Faber K, Patterson S. The impact
of rotator cuff pathology on isometric and isokinetic strength, function, and
quality of life. J Shoulder Elbow Surg. 2004; 13: 593-98.
21- Kuhlman JR, Iannotti JP, Kelly MJ, et al. measurement of isometric and
Isokinetic strength of external rotation and abduction of the shoulder. J Bone
Joint Surg Am. 1992; 74: 1320-33.
30
22- Sutbeyaz ST, Sezer N, Koseoglu BF. The effect of pulsed electromagnetic
fields in the treatment of cervical osteoarthritis: a randomized, double-blind,
sham-controlled Trial. Clauw DJ int. 2006; 26: 320-324.
Figure 1:
Table 1:
31
Table 2:
32
3.2 Artigo 2: Campo eletromagnético pulsado em pacientes com síndrome
de impacto do ombro: um estudo duplo-cego, randomizado controlado.
No anexo 7.2 a correspondência com o aceite da publicação.
3.2.1. Texto enviando para publicação APMR, versão em português.
CAMPO ELETROMAGNÉTICO PULSADO E EXERCÍCIOS EM PACIENTES
COM SÍNDROME DE IMPACTO DO OMBRO: ENSAIO CLÍNICO
CONTROLADO.
Diego Galace de Freitas (PT, MSc)1, Renan Monteiro de Lima (PT, candidato MSc)1, Freddy Beretta Marcondes (PT, candidato MSc)1 , Thiago Yukio Fukuda (PT, PhD) 1, Patrícia Maria de Moraes Barros Fucs (MD, PhD)2 1. Setor de Fisioterapia, Serviço de Reabilitação, Irmandade da Santa Casa de Misericórdia (ISCMSP), São Paulo, Brasil; 2. Departamento de Ortopedia e Traumatologia, Irmandade da Santa Casa de Misericórdia (ISCMSP), São Paulo, Brasil;
33
RESUMO Objetivo: Avaliar os efeitos de campo eletromagnético pulsado (CEMP) e exercícios na redução da dor, melhora da força muscular e função em pacientes com síndrome de impacto do ombro (SIO). Design: Ensaio clínico randomizado, duplo-cego, com acompanhamento de 3 meses pós-tratamento. Configuração: Reabilitação ambulatorial de um hospital público. Participantes: Cinquenta e seis pacientes entre 40 e 60 anos de idade, com diagnóstico de SIO, foram aleatoriamente alocados no grupo CEMP ativo (n = 26; média de idade= 50,1 anos) ou CEMP placebo (n = 30; média de idade= 50,8 anos de idade). Intervenções: Após 3 semanas de ativo ou placebo CEMP, ambos os grupos realizaram o mesmo programa de exercícios que incidiu sobre o ombro reforço. Principais desfechos: A escala visual analógica (VAS), escala de avaliação funcional da Universidade da Califórnia/Los Angeles (UCLA), Constante-Murley, e a Dinamometria manual para força muscular ombro foram usadas como medidas de resultado na linha de base (pré-tratamento), em 3 semanas (pós-CEMP ativo ou placebo), em 9 semanas (pós-exercícios) e na avaliação pós-tratamento de 3 meses. Resultados: Os pacientes no grupo CEMP ativo apresentaram maior nível de função e menos dor em todos os seguimentos em relação à linha de base (P < 05). No entanto, o grupo de CEMP placebo tinha maior função e menor dor somente no seguimento 9 semanas e 3 meses (P < 05), ou seja, melhora apenas após associar os exercícios. Para a dinamometria de ombro, o grupo CEMP ativo aumentou a força de rotação lateral em 9 semanas (P < 05) e rotação medial em 9 semanas e 3 meses (ambos, P < 05), quando comparado à linha de base. Não houve diferença para a força do ombro no grupo CEMP placebo (P > 05), e análise intergrupos (P > 05) para todas as medidas de resultado. Conclusão: A combinação de exercícios de ombro ao CEMP é eficaz na melhora da força muscular, função e para diminuir dor em pacientes com SIO. No entanto, esses resultados devem ser interpretados com cuidado em consequência da falta de diferenças entre grupos. Palavras-chave: Terapia com campo magnético, diatermia, manguito rotador. Abreviaturas: CEMP, campo eletromagnético pulsado; SIO, síndrome do impacto do ombro; EVA, escala visual analógica; UCLA, Universidade da Califórnia/Los Angeles.
34
INTRODUÇÃO
Síndrome do impacto de ombro (SIO) é considerada uma das principais
causas de dor no membro superior e pode levar à diminuição da função dessas
articulações e à redução na qualidade de vida. Afeta cerca de 20% da
população, e sua prevalência aumenta ao longo do envelhecimento1-4. Como
as principais queixas dos pacientes com SIO são dor nas articulações, rigidez e
déficit funcional, tratamentos não cirúrgicos concentraram-se no alívio dos
sintomas e melhora da função.5 A gestão de primeira linha da SIO é
representada pelo tratamento conservador, baseado em medicação, exercícios
terapêuticos e aplicação de agentes físicos.6-8 O uso de agentes físicos com
resultados analgésicos e anti-inflamatórios é muito comum na prática da
fisioterapia, porque pode fornecer benefícios similares a medicamentos, mas
sem os efeitos colaterais.
Entre os agentes físicos, o CEMP, também designado como
―magnetoterapia‖, se baseia no princípio da interação aos campos
electromagnéticos não ionizantes e sistemas biológicos, como
―bioeletromagnetismo‖.9,10 No espectro extremamente de baixa frequência de
campos eletromagnéticos (abaixo de 300 Hz), estudos experimentais sugerem
efeitos terapêuticos em várias condições patológicas, como pseudartrose11,
osteoartrite12, dor aguda e crônica de diferentes condições
musculoesqueléticas13, e aceleração da cicatrização das lesões do tendão14,15
Além disso, outros autores colocam como hipótese que os efeitos do
tratamento com o CEMP estariam relacionados ao aumento da atividade
celular local, orientação das fibras de colágeno, conteúdo de oxigênio
35
aumentada ao tecido, vasodilatação, sem aumento da temperatura
local.10,13,16,17
No entanto, a eficácia da CEMP para tratar problemas de ombro ainda
permanece controversa. Alguns ensaios clínicos demonstram resultados
positivos8,16,17, enquanto outros não mostraram os mesmos efeitos.18,19
Portanto, o objetivo deste estudo foi avaliar os efeitos da CEMP e exercícios na
redução da dor, melhora da funcionalidade e força muscular em pacientes com
SIO. Formulamos a hipótese de que os pacientes que receberam ativo CEMP e
exercícios demonstrariam resultados significativamente melhores quando
comparados com o grupo CEMP placebo.
MÉTODOS
Participantes
Cinquenta e seis pacientes com idade entre 40 e 60 anos (n = 56; média
de idade, 50,5 ± 8,9 anos), com diagnóstico de SIO, foram aleatoriamente
alocados para o grupo CEMP ativo (n = 26; média de idade, 50.1 ± 8,2 anos)
ou CEMP placebo (n = 30; média 9,6 anos de idade, 50,8 ±). Após 3 semanas
de CEMP ativo ou placebo, ambos os grupos realizaram o mesmo programa de
exercícios concentrado no fortalecimento do ombro. Quatro pacientes que
estavam no CEMP ativo e 6 pacientes que estavam no grupo CEMP placebo
não concluíram o estudo. Todos os procedimentos do estudo foram explicados
para os voluntários, e eles assinaram o termo de consentimento livre e
esclarecido, em conformidade com a resolução do Conselho Nacional de
Saúde 196/96. O estudo foi aprovado pelo Comitê de Ética da Pesquisa, com
36
número XXXXXXXXXXXXXXX, aaaa e registrado no clinicaltrials.gov (número
de registro: NCT01452204).
Cálculos de estimativa de tamanho de amostra foram baseados em
detectar melhora de 30% nos níveis de dor (escala visual analógica), e que se
fundamentam em estudo conduzido por Bang e Deyle20, assumindo nível alfa
de 05 e poder de 80%. Determinou-se o tamanho de amostra de 24 indivíduos
por grupo. Permitindo desistente, 56 indivíduos foram recrutados para este
estudo.
A amostra do estudo incluiu pacientes de ambos os sexos, de 40 a 60
anos de idade, com diagnóstico médico de SIO de grau I ou II, com base em
história de dor no ombro pelo menos havia 3 meses. Além disso, esses
pacientes já haviam recebido um exame clínico e ultrassonográfico (USG) ou
imagem de ressonância magnética (MRI), de acordo com Neer’s critérios.21 Os
pacientes deveriam apresentar elevação de ombro ativo em atividades acima
da cabeça. Essa elevação ativa do braço foi uma preocupação pelo fato de que
pacientes mais velhos com SIO poderiam apresentar possível degeneração do
manguito rotador moderada, e buscou-se assegurar que os pacientes ainda
tivessem função adequada dessa musculatura. Os participantes foram
recrutados no serviço de reabilitação por um único fisioterapeuta, com mais de
10 anos de experiência clínica em reabilitação do ombro. Os participantes
foram excluídos de acordo com os seguintes critérios: desordem neurológica;
lesão na região cervical, cotovelo ou mão; artrite reumatoide, doença cardíaca
ou cirurgia anterior envolvendo as extremidades superiores, mulher grávida ou
pacientes utilizando infiltrações, anti-inflamatório intra-articular nos últimos 60
dias. Outras patologias de ombro, como acrômio unciformes, osteoartrite,
37
capsulite adesiva ou lesões traumáticas do labrum, foram igualmente
excluídas. Durante a triagem, todos os indivíduos que usaram anti-inflamatórios
mencionados anteriormente interromperam o uso 15 dias antes de iniciar o
tratamento. No entanto, apenas 5 pacientes (2 no grupo CEMP ativo e 3 no
grupo CEMP placebo) relataram que usavam medicações orais antes do
estudo. Todos esses pacientes pararam de usar medicamentos 15 dias antes
do início do estudo e foram randomizados para um dos dois grupos.
A alocação dos dois grupos ocorreu aleatoriamente, usando envelopes
opacos, selados, cada um contendo o nome de um dos grupos (CEMP ativo ou
CEMP Placebo). Os envelopes foram escolhidos por um indivíduo não
envolvido no estudo. A alocação ao grupo aconteceu durante a avaliação
inicial, mas antes da primeira sessão de tratamento. Um único terapeuta (A) foi
responsável pela programação do equipamento (ativo ou placebo) prévio ao
tratamento. É importante destacar que esse terapeuta não ficou ao lado do
paciente durante a sessão para evitar influenciar os resultados. Dois terapeutas
(B e C) foram treinados em aplicar os protocolos de exercício utilizados para o
estudo e oferecidos em todo o tratamento. Esses terapeutas (B e C) e todos os
pacientes estavam cegos em relação ao tratamento com CEMP ativo ou CEMP
placebo. Finalmente, o examinador (D) era cego para a alocação do grupo dos
pacientes e não participou nas intervenções.
Intervenções
Os grupos CEMP ativo e placebo completaram 9 sessões, que foram
realizadas 3 vezes por semana, durante 3 semanas. A duração de cada
aplicação foi de 30 minutos e os eletrodos foram posicionados na parte anterior
38
e posterior da articulação do ombro com o sujeito posicionado em decúbito
lateral (Figura 1).
O equipamento utilizado foi o Magnetherp ® 330 (Meditea, Buenos Aires,
AR), previamente calibrado, pulsado com frequência de 50 Hz e intensidade de
20 miliTesla (mT) ou 200 Gauss (G). Como a dosimetria ideal para terapia com
campos eletromagnéticos não está ainda estabelecida16, esses parâmetros
foram predeterminados de acordo com o fabricante. Para a aplicação do
placebo, os indivíduos permaneceram na mesma posição que o grupo ativo; o
dispositivo foi ligado, mas manteve-se no modo de espera durante 30 minutos,
sem qualquer campo eletromagnético sendo aplicado.
Após três semanas de CEMP ativo ou placebo, todos os sujeitos
iniciaram um programa de exercícios terapêuticos. A duração do protocolo de
exercício foi de 6 semanas, fornecida duas vezes por semana. Todos os
sujeitos foram convidados a realizar o mesmo protocolo mais duas vezes na
semana, mas em casa. No final do tratamento, foram instruídos a continuar os
exercícios em casa. Esse protocolo continha exercícios simples para melhorar
a mobilidade do ombro e aumentar a força muscular do ombro.22 (Tabela 1).
Avaliação
A escala visual analógica (EVA), na qual 0 corresponde a nenhuma dor
e 10 à pior dor imaginável, foi usada. A EVA mostrou ser confiável e válida
para lesões no ombro, com mínima diferença clinicamente importante (MCID)
de 1,4 pontos.23
As escalas Constant-Murley24 e UCLA (Universidade da Califórnia/Los
Angeles)25 são utilizados para mensurar a função em estudos com resultados
clínicos, e são recomendadas para uso em indivíduos com distúrbios do ombro.
39
A constante-Murley é ferramenta de 100 pontos de avaliação funcional do
ombro, em que escores mais altos refletem aumento da função.24 A UCLA é
ferramenta de avaliação com 3 itens diferentes e ponderada para pontuação
máxima de 30, com escores mais altos indicando melhor função.26 O MCID da
escala constante-Murley e UCLA não está ainda bem definido, no entanto
outras escalas da extremidade superior demonstram alterações entre 6% e
13%.27
Um dinamometro manual (Lafayette Instrument Company, Lafayette, IN,
EUA) foi usado para medir a força dos músculos do manguito rotador (rotação
medial e lateral) e elevação do braço. Para medir a força dos rotadores mediais
e laterais, o sujeito foi posicionado em supino, com o ombro abduzido em 45
graus e flexionado a 30 graus (plano escapular), e o cotovelo fletido a 90 graus,
com o dinamômetro colocado no pulso.28-30 Para avaliar a força de elevação do
ombro, o sujeito permaneu sentado, o ombro abduzido em 45 graus e fletido a
30 graus, rotação neutra e o cotovelo totalmente estendido. O dinamômetro foi
colocado no pulso.30 Durante o teste de força, foram usados 2 testes força
submáximos para familiarizar os sujeitos com cada posição de teste. Isso foi
seguido em 3 repetições, com esforço isométrico máximo para cada grupo
muscular. Para análise dos dados, foram utilizados os valores médios das 3
repetições com esforço máximo. Quando o examinador observou qualquer
compensação de tronco durante um teste, os valores foram desconsiderados e
o teste foi repetido após 20 segundos de descanso. Valores de força foram
medidos em quilogramas (Kg) e normalizados pela massa corporal (kg) usando
a seguinte fórmula (força Kg/Kg de massa corporal) x 100. Resultados de
estudo piloto indicaram excelente confiabilidade, coeficientes de correlação
40
intraclasse (ICC) de 0,93 para rotadores laterais, alta confiabilidade para
elevação de ombro, com ICC de 0,88; e satisfatória para a rotação medial, com
ICC de 0,50. Todos os desfechos foram administrados antes do tratamento
(linha de base), em 3 e 9 semanas de tratamento e pós-tratamento de 3 meses
(Figura 2).
Análise de dados
Os dados foram analisados usando SPSS, versão 13.0 (SPSS Inc,
Chicago, IL de. EUA). O teste de Kolgomorov-Smirnov (com fator de correção
de Lilliefors) foi usado para testar a normalidade dos dados. A estatística
descritiva de dados demográficos e todas as medidas de resultados foram
expressas em médias e desvio-padrões (DP) com curva normal.
Homogeneidade dentro de cada grupo para gênero na linha de base foi
confirmada pelo teste do qui-quadrado. Comparação entre os grupos foi
realizada utilizando testes t independentes para idade, massa corporal, altura,
escore de dor e escalas funcionais, para determinar a homogeneidade dos
grupos na linha de base (pré-tratamento). Os dados para as duas escalas
funcionais (constante-Murley e UCLA), força muscular e a EVA foram
analisados usando separadamente modelo misto de análise de variância 2-por-
4 (grupo-por-tempo). O fator grupo tinha 2 níveis (CEMP ativo e CEMP
placebo) e o fator tempo tinha 4 níveis (pré-tratamento, 3 e 9 semanas de
tratamento e de 3 meses pós-tratamento). Se significativos efeitos principais ou
interações foram detectados, em seguida uma análise de efeitos principais
simples foi usada com ajustes de Bonferroni. Significância estatística foi
definida como p < 05. Após a análise de dados por protocolo, ocorreu a análise
41
de intenção de tratar (ITT) utilizando o valor médio obtido da última avaliação
de cada sujeito de cada grupo.
RESULTADOS
Aos 3 meses, 4 sujeitos no grupo CEMP ativo e 6 indivíduos no grupo CEMP
placebo foram perdidos durante o seguimento. Portanto, todas as análises de
dados por protocolo foram realizadas com 22 indivíduos no grupo CEMP ativo
e 24 indivíduos no grupo CEMP placebo.
Dados de base e demográfico
Não houve diferença estatisticamente significativa (P > 05) para a demografia
entre os participantes nos grupos ativo e placebo CEMP (tabela 2). Não houve
diferença estatisticamente significativa (P > 05) entre os grupos para qualquer
uma das variáveis na linha de base (pré-tratamento) (tabela 3).
Dor, função e força muscular
Houve interação de grupo-por-tempo estatisticamente significativa na
análise de modelo misto de variância (2-por-4) para todas as medidas de
avaliação funcional, força muscular e dor (P < 05). Planejadas comparações
emparelhadas para constante-Murley, UCLA e EVA indicaram que os pacientes
no grupo CEMP ativo tinham melhor função e diminuição da dor, nas
avaliações de 3 e 9 semanas e 3 meses pós-tratamento, quando comparados
com a linha de base (constante-Murley, intervalo, P < P.05 - <. 001; UCLA,
intervalo, P < P 01 - <. 001; e VAS, intervalo P < P 01 - < 001. A mesma análise
42
indicou que há diferenças significativas para dor e função no grupo CEMP
placebo apenas nas avaliações de 9 semanas e 3 meses pós-tratamento
comparado à linha de base (constante-Murley, intervalo, P < 01 e P < 001,
respectivamente; UCLA, ambos, P <. 01; e EVA, P < 01 e P < 001,
respectivamente). Para a força muscular, o grupo CEMP ativo aumentou a
força de rotação lateral em 9 semanas (P =. 02) e rotação medial na semana-9
e na avaliação de 3 meses pós-tratamento (ambos P = 03), quando comparado
à linha de base. Não houve diferença de força muscular no grupo CEMP
placebo (P > 05) durante o curso do tratamento e seguimento quando
comparado à linha de base. No entanto, a análise entre grupos, para as
avaliações de 3 e 9 semanas, e a 3 meses pós-tratamento não indicou
diferenças significativas para todos os escores de dor, escalas funcionais e
força muscular (todas, P > 05) (tabela 3). Os resultados da análise de intenção
de tratar foram consistentes com a análise por protocolo, fornecendo
evidências de que os dados em falta não tinham nenhuma influência
substancial sobre os resultados globais. É importante salientar que todos os
pacientes relataram a execução dos exercícios em casa durante o curso do
tratamento.
Análise MCID
Baseado no MCID para EVA (1.4 pontos), a proporção de pacientes que
alcançaram ou excederam o MCID na avaliação 3 semanas, em comparação
com a linha de base, foi de 61% no grupo ativo e 43% no grupo placebo.
Infelizmente, não encontramos um valor padrão de MCID para os questionários
constante-Murley e UCLA, mas há especulações de que a melhora pode ser
43
significativa em escalas gerais de ombro quando os pacientes atingem ou
excedem o MCID de 13%.27 Assim, quando examinamos a avaliação de 3
semanas, a proporção de pacientes que alcançaram ou ultrapassaram os 13%
de melhora foi 65% no grupo ativo e 24% no grupo placebo para a constante-
Murley, e 91% no grupo ativo e 54% no grupo placebo para a escala UCLA.
Na avaliação de 9 semanas e 3 meses, a proporção de sujeitos que
excederam o MCID para EVA no grupo ativo foi de 82% e 77%,
respectivamente, e no grupo placebo foi de 71% e 67%, respectivamente. A
proporção de pacientes que ultrapassou o MCID pela constante-Murley no
grupo ativo foi de 91% e 86%, respectivamente, e a proporção de pacientes
que ultrapassou o MCID pela constante-Murley no grupo placebo foi de 67% e
58%, respectivamente. Finalmente, a proporção de pacientes para a UCLA no
grupo ativo foi de 82% e 86%, respectivamente, e a proporção de pacientes
para a UCLA no grupo placebo foi de 63% para ambas as avaliações.
DISCUSSÃO
Os resultados deste ensaio clínico randomizado demonstraram que uma
intervenção de 3 semanas com CEMP é eficaz para melhorar a função e
redução da dor em pacientes com SIO. Uma combinação de exercícios de
ombro é essencial para aumentar a força muscular e potencializar essas
melhoras globais. Os grupos CEMP ativo e placebo mostraram melhoras para
todos as escalas funcionais e dor, quando combinados com exercícios de
ombro. O grupo que realizou a combinação de exercícios e CEMP ativo
mostrou melhorias na força de músculos rotadores medial e lateral, em
44
contraste com o grupo que realizou CEMP placebo e exercícios, que não
mostrou nenhuma alteração na força muscular.
Estudos clínicos anteriores demonstram que a terapia eletromagnética
pode ser ferramenta útil quando usada para facilitar a cicatrização de úlceras
de pele31, dor neuropática diabética30 e para facilitar a melhoria funcional em
pacientes com fibromialgia15,32 ou osteoartrite de joelho. 12,33,34 No entanto, os
efeitos do CEMP em pacientes com dor no ombro são ainda controversos.
18,35,36 No presente estudo, usamos um programa de tratamento completo, com
base na análise dos efeitos isolados dos CEMP e quando combinado com
exercícios. Nosso protocolo contém exercícios para intervalo de relaxamento
muscular e movimento, como exercícios de pêndulo e alongamento, e
exercícios para fortalecer os músculos do manguito rotador e estabilizadores
escapulares. Além disso, nossas avaliações se basearam em escalas
validadas previamente na literatura, aplicadas imediatamente após a aplicação
do CEMP, após exercícios e depois de 3 meses.
Alguns aspectos divergentes tornaram-se muito claros quando
analisamos a literatura sobre os pacientes que receberam terapia
eletromagnética. Aktas et al18 mostraram provas convincentes de que terapia
eletromagnética é benefício adicional na fase aguda da reabilitação da SIO. Os
autores aplicaram o CEMP durante 25 minutos por sessão, 5 dias por semana,
durante 3 semanas, com frequência de equipamento de 50 Hz e intensidade de
campo de 30 G. No presente estudo, demonstramos melhoria da função e força
muscular, e alívio da dor com frequência de equipamento de 50 Hz, intensidade
de 20 mT ou 200 G. Esse tratamento eletromagnético durou 30 minutos por
45
sessão, três dias por semana, para um total de 9 sessões. No entanto, foram
avaliados os pacientes com dor crônica e acrescentamos exercícios de
fortalecimento. Corroborando esses dados, Sultbeyaz et al32 concluíram que
CEMP de baixa frequência pode melhorar função, dor, fadiga e estado global
em pacientes com fibromialgia, utilizando sessões de 30 minutos, duas vezes
por dia, durante 3 semanas. É importante destacar que o CEMP foi
administrado para todo o corpo usando esteira magnética, que produziu
intensidade média de 40 mT e frequência variando de 0,1 a 64 Hz.32 Apesar de
usar aplicação do tipo transcraniana, Shupak et al. forneceram algum apoio
inicial para o uso do CEMP na redução da dor em populações de dor crônica
com fibromialgia e artrite reumatoide.17
Em relação ao ombro, fortalecimento de programas, alguns autores
demonstram que o exercício tem efeitos clinicamente significativos na redução
da dor e melhora da função, mas não melhora de força.7,22 Concordamos
parcialmente com essa informação, porque o protocolo de exercício utilizado
em nosso estudo levou a alívio da dor, melhora funcional, e aumento da força
muscular.
Pontos fortes e limitações do estudo
O presente estudo tem vários pontos fortes, incluindo o duplo-cego
placebo-controlado, cálculo de tamanho de efeito, análise de intenção de tratar
e confirmação do diagnóstico por pessoal experiente, que ajudou com o USG
ou ressonância magnética. Adicionais pontos fortes são os tratamentos
prestados por pessoas experientes, e avaliação multidimensional da função,
sintomas e força muscular dos pacientes. Por outro lado, podem ser limitações
46
do estudo a inclusão e a avaliação de pacientes mais velhos com SIO, que
apresentaram degeneração do manguito rotador moderada. No entanto,
acreditamos que esse viés foi minimizado porque selecionamos pacientes que
tiveram elevação acima da cabeça ativa. A degeneração do tendão teria sido a
razão para a falta de melhoria na elevação do braço em ambos os grupos. É
importante destacar que essa população é a faixa etária mais frequente
encontrada em nosso hospital. Não controlamos a execução dos exercícios de
reabilitação durante os 3 meses seguimento. No entanto, imediatamente após
o tratamento, todos os pacientes foram instruídos a manter as atividades
normais da mesma maneira que durante o tratamento. Outra limitação do
estudo foi a ausência de grupo realizando CEMP e exercícios ao mesmo
tempo. No entanto, pretendemos observar o efeito isolado da CEMP para dor e
função e posteriormente o efeito de tal associação.
Mostramos alternativa para o tratamento de pacientes com lesões
músculo-esqueléticas, especificamente a SIO, visando ao alívio da dor e à
melhora funcional. No entanto, o potencial efeito analgésico e funcional da
aplicação isolada do CEMP parece não ser tão significativo como a associação
com exercícios, especialmente tendo em conta a melhoria da força muscular.
Estudos futuros devem incluir seguimento mais longo e grupo que recebe o
CEMP e exercícios simultaneamente desde o início, e outros grupos com
diferentes parâmetros PEMF, como frequência, intensidade ou tempo de
aplicação. Além disso, não avaliamos as prováveis alterações biomecânicas
após os exercícios.
47
CONCLUSÃO
Nossos resultados sugerem que a combinação de exercícios e CEMP é
eficaz para melhorar a força muscular, função e diminuição da dor em
pacientes com SIO; no entanto, os resultados devem ser cuidadosamente
interpretados em decorrência da falta de diferenças entre grupos.
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Figura 1:
Figura 2:
Figura 2 - Ilustração do posicionamento dos eletrodos e equipamento
de campo eletromag-
nético pulsado, utilizado no estudo.
52
Tabela 1:
53
Tabela 2:
Tabela 2 - Exercícios Fundamentais de Ombro
Exercícios para Ganho de Amplitude de Movimento Ilustração
Exercício Pendular:
Fletir o tronco à frente em 90°, usar uma plataforma como
apoio ao membro que não será trabalhado e girar em
movimento circular no sentido horário e anti-horário.
Alongamento de Peitoral:
Traga o braço para o lado do corpo com o cotovelo dobrado
em 90°, antebraço em contato com a parede. Avance seu
corpo para frente da parede até sentir o alongamento do
peitoral.
Alongamento de Tríceps:
Traga o braço sobre seu corpo e use a outra mão para aplicar
pressão suportável, puxando o cotovelo.
Alongamento dos Rotadores Externos com Bastão:
Em pé, apoiado na parede, segure um bastão com ambas as mãos, palmas para cima. Os braços devem ficar posicionados ao lado do corpo e os cotovelos flexionados a 90°. Com o braço são, empurrar o braço lesionado e afastá-lo do corpo. Os cotovelos devem ficar imóveis.
Exercícios de Fortalecimento: Ilustração
Exercício de Rotação Interna (neutro):
De pé, pernas semiestendidas e afastadas na largura do
quadril, braço estendido ao longo do tronco e o lado -
lesionado na altura da cintura, segurando uma das
extremidades da faixa. Rode o braço internamente, até
aproximá-lo ao abdômen, mantendo o cotovelo junto ao
tronco.
Exercício de Rotação Externa:
De pé, pernas semiestendidas e afastadas na largura do
quadril, braço estendido ao longo do tronco e o lesionado na
altura da cintura, segurando uma das extremidades da faixa.
Rode o braço externamente até ultrapassar a linha do ombro,
mantendo o cotovelo junto ao tronco.
54
Protração Escapular:
Segure um tubo, enquanto encosta as costas na parede com o
braço flexionado a 90 °. Dar um soco com o braço para frente,
mantendo o braço esticado. Seu ombro deve sair da parede.
Rotação Externa em decúbito lateral:
Deite-se de lado sobre o lado não envolvido, com o braço
envolvido ao lado do corpo e cotovelo dobrado a 90°.
Flexionar o cotovelo do braço comprometido até chegar à
altura do peito.
55
Tabela 3:
56
3.2.2. Texto enviando para publicação APMR, versão em inglês.
PULSED ELECTROMAGNETIC FIELD AND EXERCISES IN PATIENTS WITH
SHOULDER IMPINGEMENT SYNDROME: A RANDOMIZED, DOUBLE-BLIND,
PLACEBO-CONTROLLED CLINICAL TRIAL
Diego Galace de Freitas (PT, MSc)1, Renan Monteiro de Lima (PT,
candidatoMSc)1, Freddy Beretta Marcondes (PT, candidato MSc)1 , Thiago
Yukio Fukuda (PT, PhD) 1, Patrícia Maria de Moraes Barros Fucs (MD, PhD)2
1. Physiotherapy clinic, Rehabilitation Service, Irmandade da Santa Casa de
Misericórdia (ISCMSP), São Paulo, Brasil; 2. Orthopaedic Department,
Irmandade da Santa Casa de Misericórdia (ISCMSP), São Paulo, Brasil;
57
ABSTRACT
Objective: To evaluate the effects of pulsed electromagnetic field (PEMF) and exercises in reducing pain and improving function and muscle strength in patients with shoulder impingement syndrome (SIS).
Design: Double-blind randomized clinical trial, with a 3 month post-treatment follow-up.
Setting: Outpatient Rehabilitation of a public hospital
Participants: Fifty-six patients between 40 and 60 years of age, with a diagnosis of SIS, were randomly assigned active PEMF (n = 26; mean age, 50.1 years) or placebo PEMF (n = 30; mean age, 50.8 years old).
Interventions: After 3 weeks of active or placebo PEMF, both groups performed the same program of exercises that focused on shoulder strengthening. Main Outcome Measures: A visual analogue scale (VAS), the University of California/Los Angeles (UCLA) shoulder rating scale, the Constant-Murley shoulder score, and the hand-held dynamometry for muscle strength were used as outcome measures at baseline (pretreatment), at 3 weeks (post active or placebo PEMF), at 9 weeks (post-exercises), and at 3 months post-treatment. Results: The patients in the active PEMF group had a higher level of function and less pain at all follow-up timeframes compared to baseline (P<.05). However, the placebo PEMF group had increased function and reduced pain only at 9 weeks and 3 months follow-ups (P<.05), i.e., after performing the associated to exercises. For the shoulder dynamometry, the active PEMF group had increased strength for lateral rotation at 9 weeks (P<.05) and medial rotation at 9 weeks and 3 months (both, P<.05) when compared to baseline. There was no difference for shoulder strength in the placebo PEMF group (P>.05), as well as the analysis between-groups (P>.05) for all outcome measures. Conclusion: The combination of PEMF and shoulder exercises is effective in improving function and muscle strength and decreasing pain in patients with SIS. However, these results should be carefully interpreted due to the lack of differences between groups.
Keywords: Magnetic field therapy, diathermy, shoulder impingement syndrome, and rotator cuff.
Abbreviations: PEMF, Pulsed electromagnetic field; SIS, Shoulder impingement syndrome; VAS, Visual analogue scale; UCLA, University of California/Los Angeles
58
INTRODUCTION
Shoulder impingement syndrome (SIS) is considered one of the main
causes of pain in the upper extremity, and can lead to a decrease in the
function of this joint and a reduction in quality of life. It affects about 20% of the
population, and its prevalence increases over the course of aging.1-4 Since the
main complaints of patients with SIS are joint pain, stiffness and functional
deficit, non-surgical treatments have focused on symptom relief and improved
function.5 The first-line management of SIS is represented by conservative
treatment, based on medication, therapeutic exercises, and the application of
physical agents.6-8 The use of physical agents with analgesic and anti-
inflammatory outcomes are very common in physical therapy practice because
they may provide benefits similar to medications, but without the same side
effects.
Among these physical agents, the pulsed electromagnetic field (PEMF),
also commonly referred to as "magnet therapy" is based on the principle of the
interaction between non-ionizing electromagnetic fields and biological systems,
ie., ―bioelectromagnetics‖.9,10 In the extremely low frequency spectrum of
electromagnetic fields (below 300 Hz), experimental studies have suggested
therapeutic effects in various pathological conditions, such as
pseudoarthrosis11, osteoarthritis12, acute and chronic pain from different
musculoskeletal conditions13, as well as accelerating the healing of tendon
injuries14,15 Additionally, other authors hypothesize that PEMF treatment effects
may be related to increased local cellular activity, orientation of collagen fibers,
increased oxygen content to tissue, vasodilatating blood vessels, without
increasing local temperature.10,13,16,17
However, the effectiveness of PEMF to treat shoulder problems still
remains controversial. Some clinical trials have shown positive results8,16,17,
while other clinical trials did not show the same effects.18,19 Therefore, the
purpose of this study was to evaluate the effects of PEMF and exercises on
pain reducing, improved functionality and enhanced muscle strength in patients
with shoulder impingement syndrome. We hypothesized that the patients who
59
received active PEMF and exercises would demonstrate significantly better
results when compared to placebo PEMF and exercises.
METHODS
Participants
Fifty-six patients aged 40 and 60 years (n = 56; mean age, 50.5 ± 8.9
years), with a diagnosis of SIS, were randomly assigned to active PEMF (n =
26; mean age, 50.1 ± 8.2 years) or placebo PEMF (n = 30; mean age, 50.8 ±
9.6 years). After 3 weeks of active or placebo PEMF, both groups performed the
same program of exercises focusing on shoulder strengthening. Four patients
that were in the active PEMF and 6 patients that were in the placebo PEMF
group did not complete the study. All study procedures were explained to the
volunteers, and they signed informed consent forms in accordance with the
National Health Council Resolution No. 196/96. The study was approved by the
Research Ethics Committee of XXXXXXXXXXXXXXX, YYYY, and registered at
clinicaltrials.gov (registration number: NCT01452204).
Sample-size estimation calculations were based on detecting a 30%
improvement in pain scores (visual analogue scale), which was based on a
previously study conducted by Bang and Deyle20, assuming an alpha level of
.05, and 80% power. A sample size of 24 subjects per group was determined.
Allowing dropout, 56 subjects were recruited for this study.
The study sample included patients of both genders, with a SIS medical
diagnosis of grade I or II based on a history of shoulder pain for at least 3
months. Furthermore, these patients had previously received a clinical
examination and ultrasonographic (USG) or magnetic resonance image (MRI),
according to Neer´s criteria.21 The patients should present an active shoulder
elevation in overhead activities. This active overhead elevation of the arm was a
concern due to the fact that older patients with SIS were being evaluated with
possible moderate rotator cuff degeneration; we attempted to assure that these
patients still had adequate function of this musculature. The participants were
60
recruited from the Rehabilitation Service - XXXX, by a single physical therapist
with more than 10 years of clinical experience in shoulder rehabilitation.
Participants were excluded if they met one of the following criteria: had a
neurological disorder; injury to the cervical region, elbow, or hand; rheumatoid
arthritis, a heart condition, or previous surgery involving the upper extremities.
Also excluded was pregnant woman or patients utilizing intra-articular anti-
inflammatory infiltrations in the past 60 days. Subjects who had other shoulder
pathologies, such as hooked acromion, osteoarthritis, adhesive capsulitis, or
traumatic labrum tears, were also excluded. During the screening, all subjects
who used anti-inflammatory medications previously mentioned interrupted by 15
days before starting the treatment. However, only 5 patients (2 in the active
PEMF and 3 in the placebo PEMF) reported using oral medications prior to the
study. All these patients stopped using medications 15 days before the
beginning of the study and were randomized to one of the two groups.
The assignment of subjects to the 2 groups was performed randomly
using opaque, sealed envelopes, each containing the name of one of the
groups (Active PEMF of Placebo PEMF). The envelopes were picked by an
individual not involved in the study. Group assignment was performed following
the initial evaluation but prior to the initial treatment session. A single therapist
(A) was responsible for setting up the equipment (active or placebo) prior to
treatment in order to maintain the randomized, double-blind. It is important to
highlight that this therapist did not remain beside the patient during the session
to avoid influencing the results. Two therapists (B and C) were trained in
delivering the exercise protocols used for the study and provided all treatment.
These therapists (B and C) and all patients were blinded in relation to active
PEMF or placebo PEMF treatment. Finally, the examiner (D) was blind to the
group assignment of the patients and did not participate in the interventions.
Interventions
The active PEMF and placebo PEMF groups completed 9 sessions that
were provided 3 times per week for 3 weeks. The duration of each application
was 30 minutes and the electrodes were positioned on the anterior and
61
posterior part of the shoulder joint with the subject positioned in lateral
decubitus (FIGURE 1).
The equipment used was Magnetherp® 330 (Meditea, Buenos Aires,
AR), previously calibrated, pulsed with a frequency of 50 Hz and an intensity of
20 miliTesla (mT) or 200 Gauss (G). As the optimal dosimetry for therapy with
electromagnetic fields is yet not established16, these parameters were
predetermined according to the manufacturer. For the placebo application, the
subjects remained in the same position as the active group; the device was
turned on but kept in standby mode during 30 minutes without any
electromagnetic field being applied.
After three weeks of active or placebo PEMF, all subjects initiated a
therapeutic exercise program. The exercise protocol duration was 6 weeks, and
was provided twice a week. All subjects were asked to perform the same
protocol two more times at home during the week. At the end of treatment, they
were instructed to continue the exercises at home. This protocol contained
simple exercises for improving shoulder mobility and for increasing shoulder
girdle muscle strength.22 (TABLE 1).
Evaluation
A visual analogue scale (VAS), where 0 corresponded to no pain and 10
to the worst imaginable pain, was used to measure pain during the last week.
The VAS has been shown to be reliable and valid for shoulder injuries, with a
minimal clinically important difference (MCID) of 1.4 points.23
The Constant-Murley24 and UCLA (University of California/Los Angeles)25
scales have been used to measure function in clinical outcome studies and are
recommended for use for individuals with shoulder disorders. The Constant-
Murley is a 100-point functional shoulder-assessment tool in which higher
scores reflect increased function.24 The UCLA is a 3-item assessment tool with
items differentially weighted for a maximum score of 30, with higher scores also
indicating better function.26 The MCID of the Constant-Murley and UCLA scales
is not yet well defined, however other upper extremity scales have shown
changes between 6% and 13%.27
62
Hand-held dynamometry (Lafayette Instrument Company, Lafayette, IN,
USA) was used for measuring strength of the rotator cuff muscles (medial and
lateral rotation) and arm elevation. To measure the strength of the medial and
lateral rotators, the subject was positioned in supine with the shoulder abducted
at 45 degrees and flexed at 30 degrees (scapular plane), and the elbow flexed
at 90 degrees, with the dynamometer placed on the wrist.28-30 To assess the
shoulder elevation strength, the subject remained seated, the shoulder
abducted at 45 degrees and flexed at 30 degrees, neutral rotation, and the
elbow fully extended. The dynamometer was placed on the dorsal aspect of the
wrist.30 During strength testing, we used 2 sub maximum trials to familiarize the
subjects with each test position. This was followed by 3 trials with maximum
isometric effort for each muscle group. For data analysis, the average values of
the 3 trials with maximum effort were used. When the examiner observed any
trunk compensation during a test, values were disregarded and the test was
repeated after 20 seconds of rest. Strength values were measured in kilograms
(Kg) and were normalized by body mass (kg) using the following formula (Kg
strength / Kg body mass) x 100. Results of a pilot study indicated excellent
reliability, intra-class correlation coefficients (ICCs) of 0.93 for lateral rotators,
high reliability for shoulder elevation, with an ICC of 0.88; and satisfactory for
medial rotation, with an ICC of 0.50. All outcome measures were administered
before treatment (baseline), at 3 and 9 weeks of treatment, and 3 months post-
treatment (FIGURE 2).
Data analysis
Data were analyzed using SPSS, version 13.0 (SPSS Inc, Chicago, IL.
USA). The Kolgomorov-Smirnov test (with Lilliefors correction factor) was used
to test the normality of the data. Descriptive statistics for demographic data and
all outcome measures were expressed as averages and standard deviations
(SD) with a normal curve. The homogeneity within-group for gender at baseline
was confirmed by the chi-square test. Comparison between the groups was
performed using independent t tests for age, body mass, height, pain score, and
functional scales to determine homogeneity of the groups at baseline
(pretreatment). The data for the 2 functional scales (Constant-Murley and
63
UCLA), muscle strength, and the VAS were analyzed using separate 2-by-4
(group-by-time) mixed model analysis of variance. The factor of group had 2
levels (active PEMF and placebo PEMF) and the repeated factor of time had 4
levels (pretreatment, 3 and 9 weeks of treatment, and 3 months post-treatment).
If significant main effects or interactions were detected, then a simple main
effects analysis continued using Bonferroni adjustments. Statistical significance
was defined as p<.05. After the per-protocol data analysis, an intention-to-treat
analysis (ITT) was performed using the mean value obtained from the
remaining subjects of each group.
RESULTS
At 3 months, 4 subjects in the active PEMF group and 6 subjects in the
placebo PEMF group were lost during follow-up. Therefore, all per-protocol data
analyses were performed with 22 subjects in the active PEMF group and 24
subjects in the placebo PEMF group.
Baseline and Demographic data
There was no statistically significant difference (P>.05) for demographics
between the participants in the active and placebo PEMF groups (TABLE 2).
There was also no statistically significant difference (P>.05) between groups for
any of the outcome variables at baseline (pretreatment) (TABLE 3).
Pain, Function and Muscle Strength
There was a statistically significant group-by-time interaction for the 2-by-
4 mixed-model analysis of variance for pain, muscle strength and all functional
assessment measures (P<.05). Planned pairwise comparisons for Constant-
Murley, UCLA, and VAS indicated that the patients in the active PEMF group
had better function and decreased pain at 3 and 9 weeks assessments and 3
months post-treatment compared to baseline (Constant-Murley, range, P<.05 -
P<.001; UCLA, range, P<.01 - P<.001; and VAS, range P<.01 - P<.001). The
same analysis indicated that the only significant differences for function and
pain in the placebo PEMF group were found at 9 weeks assessment and 3
64
months post-treatment (Constant-Murley, P<.01 and P<.001, respectively;
UCLA, both, P<.01; and VAS, P<.01 and P<.001, respectively). For the muscle
strength, the active PEMF group had increased strength for lateral rotation at 9
weeks (P=.02) and medial rotation at the 9-week and the 3-month assessment
post-treatment (both, P=.03) when compared to baseline. There was no
difference for muscle strength in the placebo PEMF group (P>.05) during the
course of the treatment and follow-up when compared to baseline. However,
the between-group analysis at the 3- and 9-week assessments, as well the 3-
month post-treatment indicated no significant difference for all pain scores,
functional scales, and muscle strength (all, P>.05) (TABLE 3). The results of the
intention-to-treat analysis were consistent with the per-protocol analysis,
providing evidence that the missing data had no substantial influence on the
overall results. It is important to highlight that all patients reported performing
the exercises at home during the course of treatment.
MCID Analysis
Based on the MCID for the VAS (1.4 points), the proportion of patients
who met or exceeded the MCID in the 3-week evaluation (i.e. post active or
placebo PEMF) compared with baseline was 61% in the active group and 43%
in the placebo group. Unfortunately, we did not find an MCID standard value for
the Constant-Murley and UCLA questionnaires, but there is speculation that
improvement can be significant in general shoulder scales when the proportion
of patients who meet or exceed the MCID is above 13%.27 Thus, when we
examined the 3-week evaluation, the proportion of patients who met or
exceeded 13% of improvement was 65% in the active group and 24% in the
placebo group for the Constant-Murley, and 91% in the active group and 54% in
the placebo group for the UCLA scale.
In the 9-week and 3-month evaluation, the proportion exceeding MCID
for VAS in the active group was 82% and 77%, respectively, and the proportion
exceeding MCID for VAS in the placebo group was 71% and 67%, respectively.
The proportion of patients who surpassed the MCID for Constant-Murley in the
active group was 91% and 86%, respectively, and the proportion of patients
65
who surpassed the MCID for Constant-Murley in the placebo group was 67%
and 58%, respectively. Finally, the proportion of patients for the UCLA in the
active group was 82% and 86%, respectively, and the proportion of patients for
the UCLA in the placebo group was 63% for both evaluations.
DISCUSSION
The results of this randomized clinical trial demonstrated that a 3-week
intervention with PEMF is effective for improving function and reducing pain in
patients with SIS. A combination of shoulder exercises is essential for
increasing muscle strength and increasing the overall effectiveness of these
improvements. Both active and placebo PEMF groups showed improvements
for all functional and pain outcome measures when combined with shoulder
exercises. The group that performed a combination of active PEMF and
exercises showed improvements for medial and lateral rotators muscle strength,
in contrast to the group that performed placebo PEMF and exercises, which
showed no changes in muscle strength.
Previous clinical studies have shown that electromagnetic therapy can be
a useful tool when used to facilitate the healing of skin ulcers31, when used to
manage diabetic neuropathic pain30, and when used to facilitate functional
improvement in patients with fibromyalgia15,32 or knee osteoarthritis.12,33,34
However, the PEMF effects in patients with shoulder pain are still
controversial.18,35,36 In the present study, we used a full treatment program
based on analyzing the isolated effects of PEMF and when combined with
exercises. Our protocol contained exercises for range of motion and muscle
relaxation as pendulum exercises and stretching, as well as exercises to
strengthen the rotator cuff muscles and scapular stabilizers. Our assessments,
which are based on previously validated assessment scales in the literature,
were applied immediately after PEMF application, after exercises, and after 3
months.
Some divergent aspects became very clear when we analyzed the
literature regarding patients who received electromagnetic therapy. Aktas et al18
66
showed no convincing evidence that electromagnetic therapy is of additional
benefit in the acute phase of SIS rehabilitation. The authors applied PEMF
during 25 minutes per session, 5 days per week for 3 weeks with an equipment
frequency of 50 Hz and field intensity of 30 G. In the present study, we
demonstrated improved function and muscle strength, as well as pain relief with
an equipment frequency of 50 Hz, intensity of 20 mT or 200 G. This
electromagnetic treatment lasted 30 minutes per session, 3 days per week, for
a total of 9 sessions. However, we assessed patients with chronic pain and also
we added strengthening exercises. Corroborating these data, Sultbeyaz et al32
concluded that low-frequency PEMF might improve function, pain, fatigue, and
global status in patients with fibromyalgia using 30 minute sessions, twice a day
for 3 weeks. It is important to highlight that PEMF was administered to the
whole body using a magnetic mat, which produced a mean intensity of 40 mT
and frequency ranging from 0.1 to 64 Hz.32 Despite using an trans-cranial-type
application, Shupak et al also provided some initial support for the use of PEMF
in reducing pain in chronic pain populations with fibromyalgia and rheumatoid
arthritis.17
In relation to shoulder strengthening programs, some authors have
demonstrated that exercise has clinically significant effects on pain reduction
and improving function, but not strength improvement.7,22 We partially agree
with this information, because the exercise protocol used in our study led to
pain relief and functional improvement, as well as increased muscle strength.
Study strengths and limitations
The present study has several strengths, including the randomized
double-blind placebo-controlled design, effect-size calculation, intention-to-treat
analysis, and confirmation of diagnosis by experienced personnel who helped
with the USG or MRI. Additional strengths are the treatments provided by
experienced personnel, and the multidimensional evaluation of patient´s
function, symptoms, and muscle strength. On the other hand, a limitation of the
study may have been the inclusion and assessment of older patients with SIS,
who presented moderate rotator cuff degeneration. Nevertheless, we believe
67
this bias was minimized because we selected patients who had an active
overhead elevation of the arm. This tendon degeneration may have been the
reason for the lack of improvement in arm elevation in both groups. It is
important to highlight that this population is the most frequent age group found
in our shoulder policlinics hospital. We did not control whether the patients
performed their rehabilitation exercises during the 3-month follow-up. However,
immediately after treatment, all patients were instructed to maintain their normal
activities in the same manner that they were performed during treatment.
Another limitation of the study was the absence of a group performing PEMF
and exercises at the same time. However, we intended to observe the isolated
effect of PEMF for pain and function, and subsequently the effect of such an
association.
We showed an alternative for treating patients with musculoskeletal
injuries, specifically the SIS, aimed at pain relief and functional improvement.
However, this potential analgesic and functional effect of the isolated PEMF
application does not seem to be as significant as if associated with exercises,
especially taking into account the muscle strength improvement. Future studies
should include a longer follow-up and a group which receives PEMF and
exercises simultaneously from the very beginning, as well as other groups with
different PEMF parameters, such as intensity, frequency, or application time.
Furthermore, we did not evaluate the likely biomechanical changes after the
exercises were completed.
CONCLUSION
Our findings suggest that the combination of PEMF and shoulder
exercises is effective in improving function and muscle strength and decreasing
pain in patients with SIS, however, these results should be carefully interpreted
due to the lack of between-group differences.
68
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double-blind sham-controlled trial. Wien Klin Wochenschr 2002;114(15-16):678-84. 13- Prato FS, Thomas AW, Cook CM. Extremely low frequency magnetic fields (ELFMF) and pain therapy. In: Advances in Electromagnetic Fields in Living Systems 2005;4:155-87. 14- Lee EW, Maffulli N, Li CK, Chan KM. Pulsed magnetic and electromagnetic fields in experimental achilles tendonitis in the rat: a prospective randomized study. Arch Phys Med Rehabil 1997;78:399-404. 15- Strauch B, Patel MK, Rosen DJ, Mahadevia S, Brindzei N, Pilla AA. Pulsed magnetic field therapy increases tensile strength in a rat achilles’ tendon repair model. J Hand Surg 2006; 31(7):1131-5. 16- Quittan M, Schuhfried O, Wiesinger GF, Fialka-Moser V. Clinical effectiveness of magnetic field therapy: A review of the literature. Acta Med Austriaca 2000,27:61-8. 17- Shupak NM, McKay JC, Nielson WR, Rollman GB, Prato FS, Thomas AW. Exposure to a specific pulsed low-frequency magnetic field: A double-blind placebo-controlled study of effects on pain ratings in rheumatoid arthritis and fibromyalgia patients. Pain Res Manag 2006;11(2):85-90. 18- Aktas I, Akgun K, Cakmak B. Therapeutic effect of pulsed electromagnetic field in conservative treatment of subacromial impingement syndrome. Clin Rheumatol 2007;26:1234-39. 19- Green S, Buchbinder R, Glazier R, Forbes A. Systematic review of randomized controlled trials of interventions for painful shoulder: selection criteria, outcome assessment, and efficacy. BMJ 1998 316:354-60. 20- Bang MD, Deyle GD. Comparison of supervised exercise with and without manual physical therapy for patients with shoulder impingement Syndrome. J Orthop Sports Phys Ther 2000;30:126-37 21- Neer CS. Impingement lesions. Clin Orthop Relat Res. 1983;173:70-7. 22- Kuhn JE. Exercise in the treatment of rotator cuff impingement: A systematic review and a synthesized evidence-based rehabilitation protocol. J Shoulder Elbow Surg 2009;18:138-60. 23- Tashjian RZ, Deloach J, Porucznik CA, Powell AP. Minimal clinically important differences (MCID) and patient acceptable symptomatic state (PASS) for visual analog scales (VAS) measuring pain in patients treated for rotator cuff disease. J Shoulder Elbow Surg, 2009;18:927-32. 24- Constant CR, Murley AH. A clinical method of functional assessment of the shoulder. Clin Orthop Relat Res. 1987;214:160-4.
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25- Ellman H, Hanker G, Bayer M. Repair of the rotator cuff. End-result study of factors influencing reconstruction. J Bone Joint Surg Am 1986;68(8):1136-44. 26- Oku EC, Andrade AP, Stadiniky SP, Carrera EF, Tellini GG. Tradução e adaptação cultural do Modified-University of California at Los Angeles shoulder rating scale para a lingual portuguesa. Rev Bras Reumatol 2006;46(4):246-52. 27- Schmitt JS, Fabio RPD. Reliable change and minimum important difference (MID) proportions facilitated group responsiveness comparisons using individual threshold criteria. J Clin Epidemiol. 2004; 57(10):1008-18 28- Kuhlman JR, Iannotti JP, Kelly MJ, et al. Isokinetic and isometric measurement of strength of external rotation and abduction of the shoulder. J Bone Joint Surg Am 1992;74:1320-33. 29- MacDermid JC, Ramos J, Drosdowech D, Faber K, Patterson S. The impact of rotator cuff pathology on isometric and isokinetic strength, function, and quality of life. J Shoulder Elbow Surg 2004;13(6):593-98. 30- Marcondes FB, Rosa SG, Vasconcelos RA, Basta A, Freitas DG, Fukuda TY. Força do manguito rotador em indivíduos com síndrome do impacto comparado ao lado assintomático. Acta Ortop Bras 2011;19(6):333-7. 31- Ieran M, Zaffuto S, Bagnacani M, Annovi M, Moratti A, Cadossi R. Effect of low frequency pulsing electromagnetic fields on skin ulcers of venous origin in humans: a duble-blind study. J Orthop Res 1990;8:276-82. 32- Sutbeyaz ST, Sezer N, Koseoglu F, Kibar S. Low-frequency pulsed electromagnetic field therapy in fibromyalgia: A randomized, double-blind, sham-controlled clinical study. Clin J Pain 2009; 25:772-8. 33- Fukuda TY, Ovanessian V, Cunha RA, Jacob Filho Z, Cazarini Jr C, Rienzo FA, Centini AA. Pulsed short wave effect in pain and function in patients with knee osteoarthritis. J Appl Res 2008;8(3):189-98. 34- Fukuda TY, Cunha RA, Fukuda VO, Rienzo FA, Cazarini C, Carvalho NAA, Centini AA. Pulsed shortwave treatment in women with knee osteoarthritis: a multicenter, randomized, placebo-controlled clinical trial. Phys Ther 2011;91(7):1009-17. 35- Weintraub MI, Hermann DN, Smith AG, Backonja MM, Cole SP. Pulsed electromagnetic fields to reduce diabetic neuropathic pain and stimulate neuronal repair: a randomized controlled trial. Arch Phys Med Rehabil. 2009;90(7):1102-9. 36- Binder A, Parr G, Hazlemann B, Fitton-Jacksson S. Pulsed electromagnetic field therapy of persistent rotator cuff tendonitis: a duble-blind contolled assessment. Lancet 1984;323(8379):695-8.
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4. CONSIDERAÇÕES FINAIS
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4. Considerações Finais
Nossos resultados sugerem que o CEMP é eficaz na melhora da função e
diminuição da dor em pacientes com SIO; no entanto, a combinação de
exercícios de ombro deve ser incorporada em todos os protocolos de
reabilitação, visando potencializar essas melhorias e aumentar a força
muscular.
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5. REFERÊNCIAS BIBLIOGRÁFICAS
79
5. Referências Bibliográficas
1. Junior JF. Bioeletromagnetismo. Medicina biofísica 2000. 41-44. 2. Shupak NM. Therapeutic uses of pulsed magnetic-field exposure: A review. Radio Science Bulletin 2003, 9-32. 3. Bassett CAL. Beneficial Effects of Electromagnetic Fields. Journal of Cellular Biochemistry 1993; 51:387-393 4. Ronzio AO e Capponi RID. Magnetoterapia: um acercamiento a sus efectos y dosificación. Revista cientifica colegio de kinesiólogos de la provincia de buenos aires 2008; 27: 19-25. 5. Kumar VS, Kumar DA, Kalaivani K, Gangadharan AC, Raju KVSN, Thejomoorthy P, et al. Optimization of Pulsed Electromagnetic Field Therapy for Management of Arthritis in Rats. Bioelectromagnetics 2005; 26:431-439. 6. Sutbeyaz ST, Sezer N e Koseoglu BF. The effect of pulsed electromagnetic fields in the treatment of cervical osteoarthritis: a randomized, double-blind, sham-controlled trial. Rheumatology International 2006; 26: 320-324. 7. Tepper OM, Callaghan MJ, Chang EI, Galiano RD, Bhatt KA, Baharestani S, et al. Electromagnetic fields increase in vitro and in vivo angiogenesis through endothelial release of FGF-2. The FASEB Journal 2004; 18: 1-16. 8. Cools AM, Cambier D, Witvrouw EE. Screening the athlete’s shoulder for impingement symptoms: a clinical reasoning algorithm for early detection of shoulder pathology. Br J Sports Med. 2008;42:628-35. 9. Fodor D, Poanta L, Felea I, Rednic S, Bolosiu H. Shoulder impingement syndrome: correlations between clinical tests and ultrasonographic findings. Ortop TraumatolRehabil 2009;11:120-6. 10. Graichen H, Bonel H, Stammberger T, Englmeier KH, Reiser 309 M, Eckstein F. Subacromial space width changes during abduction and rotation: a 3-D MR imaging study. Surg Radiol Anat 1999;21:59-64. 11. Neer CS. Anterior acromioplasty for the chronic impingement syndrome in the shoulder: a preliminary report. J Bone Joint Surg Am 1972;54:41-50 12. McCarthy CJ, Callaghan MJ, Oldham JA. Pulsed electromagnetic energy treatment offers no clinical benefit in reducing the pain of knee osteoarthritis: a systematic review. BMC 2006;7:51 13. Shupak NM. Therapeutic uses of pulsed magnetic-field exposure: a review. The Radio Scien Bulletin 2003,307:9-32.
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14. Nikolakis P, Kollmitzer J, Crevenna R, Bittner C, Erdogmus CB, Nicolakis J. Pulsed magnetic field therapy for osteoarthritis of the knee: A double-blind sham-controlled trial. Wien Klin Wochenschr 2002;114(15-16):678-84. 15. Constant CR, Murley AH. A clinical method of functional assessment of the shoulder. Clin Orthop Relat Res. 1987;214:160-4. 16. Oku EC, Andrade AP, Stadiniky SP, Carrera EF, Tellini GG. Tradução e adaptação cultural do Modified-University of California at Los Angeles shoulder rating scale para a lingual portuguesa. Rev Bras Reumatol 2006;46(4):246-52. 17. Shupak NM, McKay JC, Nielson WR, et al. Exposure to a specific pulsed low– frequency magnetic field: a double-blind placebo-controlled study of effects on pain ratings in rheumatoid arthritis and fibromyalgia patients. Pain Res Manag 2006;11:85-90. 18. Sutbeyaz ST, Sezer N, Koseoglu F, Kibar S. Low-frequency pulsed electromagnetic field therapy in fibromyalgia: A randomized, double-blind, sham-controlled clinical study. Clin J Pain 2009; 25:772-8. 19. Schmitt JS, Fabio RPD. Reliable change and minimum important difference (MID) proportions facilitated group responsiveness comparisons using individual threshold criteria. J Clin Epidemiol. 2004; 57(10):1008-18 20. Marcondes FB, Rosa SG, Vasconcelos RA, Basta A, Freitas DG, Fukuda TY. Força do manguito rotador em indivíduos com síndrome do impacto comparado ao lado assintomático. Acta Ortop Bras 2011;19(6):333-7. 21. Ieran M, Zaffuto S, Bagnacani M, Annovi M, Moratti A, Cadossi R. Effect of low frequency pulsing electromagnetic fields on skin ulcers of venous origin in humans: a duble-blind study. J Orthop Res 1990;8:276-82. 22. Haahr JP, Ostergaard S, Dalsgaard J, Norup K, Frost P, Lausen S, Holm EA, Andersen JH. Exercises versus arthroscopic decompression in patients with subacromial impingement: a randomised, controlled study in 90 cases with a one year follow up. Ann Rheum Dis 2005;64:760-4. 23. Lombardi Jr I, Magri AG, Fleury AM, Da Silva AC, Natour J. Progressive resistance training in patients with shoulder impingement syndrome: A randomized controlled trial. Arthritis Rheum 2008;59(5):615-22. 24. Rabini A, Piazzini DB, Bertolini C, Deriu L, Saccomanno MF, Santagada DA, Sgadari A, Bernabei R, Fabbriciani C, Marzetti E, Milano G. Effects of local microwave diathermy on shoulder pain and function in patients with rotator cuff tendinopathy in comparison to subacromial corticosteroid injections: a single-blind randomized trial. J Orthop Sports Phys Ther 2012;42(4):363-70. 25. Guerkov HH, Lohmann CH, Liu Y, Dean DD, Simon BJ, Heckman JD, Schwartz Z, Boyan BD. Pulsed electromagnetic fields increase growth factor release by nonunion cells. Clin Orthop Relat Res 2001;384:265-79.
81
6. FONTES CONSULTADAS
82
6. Fontes consultadas
Associação Brasileira de Normas Técnicas. NBR 6023. Informação e
documentação-referências-elaboração. Rio de Janeiro, 2002.
Ferreira ABH. Dicionário Aurélio da Língua Portuguesa. 3ª Ed. Curitiba: Editora
Positivo; 2004.
Houaiss A, Villar MS. Dicionário Houaiss da Língua Portuguesa. Rio de Janeiro:
Objetiva; 2001
Normatização da elaboração de teses da Faculdade de Ciências Médicas da
Santa Casa de São Paulo.
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7. ANEXOS
84
7. Anexos
7.1 Anexo 1
Email de aceite revista:
85
7.2 Anexo 2
Email de submissão da revista
86
7.3 Anexo 3
Comite de Ética
87
7.4 Carta de solicitação de troca de titulo CEP
88
7.5 Normas para publicação das Revistas submetidas.
7.5.1 JARCET
Manuscript Submissions
The Journal of Applied Research invites submission of clinical and
laboratory research manuscripts in all areas of medicine, including
pathophysiology, diagnosis, treatment, and prognosis. Manuscripts must be
previously unpublished and cannot be simultaneously under consideration with
another publisher. The publisher will require the authors to sign a document
warranting that the material does not violate any copyright or other intellectual
rights and assigning the copyrights to The Journal of Applied Research.
All manuscripts will be subject to editing before they are published.
Manuscript Submission: Manuscripts should be submitted electronicly
(to [email protected]) compatible with Microsoft Word, WordPerfect, or ASCII.
Text must be double-spaced. A copy of the manuscript should also be sent to:
The Journal of Applied Research
P.O. Box 2083
Apopka, FL 32704-2083
USA
In addition your cover letter should include at least the name and contact
information (e-mail address) for two qualified reviewers for your paper.
References should be listed in order of citation in the text and enumerated
with Arabic numerals.
Tables and diagrams may be submitted with the manuscript if they serve to
clarify discussion.
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All illustrations must have the author's name, figure number and TOP
indicated clearly on the back. Slides should have this information on the slide
mount. Illustrations may be submitted in color but will be converted to black and
white and thus should be considered with this in mind. Illustrations will be
handled carefully and will be returned to the author, but the publisher cannot be
held responsible for originals. Authors are advised to retain duplicates.
The Journal of Applied Research does not accept advertising. In order to
offset production charges, authors will be assessed a fee per published
page. Fellowships are available to offset the standard page fee in the case of
hardship. Please consult the publisher.
Authors will be given an opportunity to order reprints of their articles when
they receive their copy of the final, edited manuscript (proofs).
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7.5.2. APMR
Archives of Physical Medicine and Rehabilitation publishes original articles
that report on important trends and developments in physical medicine and
rehabilitation and in the more interdisciplinary field of rehabilitation. Archives of
Physical Medicine and Rehabilitation brings readers authoritative information
on the therapeutic utilization of physical and pharmaceutical agents in providing
comprehensive care for persons with disabilities and chronically ill
individuals. Archives began publication in 1920, publishes monthly, and is the
official journal of the ACRM | American Congress of Rehabilitation Medicine. Its
papers are cited more often than any other rehabilitation journal.
INSTRUCTIONS FOR AUTHORS
Compliance for Submission
Publication Ethics
Sponsored Articles and Open Access
Editorial Process
Publication Categories
Manuscript Preparation
• Glossary of Methodologic Terms
• Checklist for Compliance and Submission
COMPLIANCE for SUBMISSION
Compliance with journal policies includes:
Authorship
Authors have read the submitted manuscript and vouch for its accuracy. All
authors have participated sufficiently in the conception and design of this work
and the analysis of the data (where applicable), as well as the writing of the
manuscript, to take public responsibility for its content. If any author (or group of
authors) listed cannot verify substantial contribution, the author's name should
91
be moved to the acknowledgment section. If requested, authors shall produce
the data on which the manuscript is based for examination by Archives or its
assignees.
Authors warrant the manuscript is original and its essential substance, tables, or
figures have not been previously published in part or in whole. The manuscript
or one with substantially similar content under declared authorship or the data
within it has not been accepted for publication elsewhere and it is not presently
under review by any other publisher. The manuscript will not be submitted for
publication elsewhere until a decision has been made on its acceptability for
publication in Archives. This restriction does not apply to brief abstracts or press
reports published in connection with scientific meetings.
Disclosure & Forms
The Archives utilizes three disclosure forms:
(1) the ICMJE Form for Disclosure of Potential Conflicts of Interest,
(2) the Archives' Authorship Form & Copyright Assignment for Provisional
Disclosure at Original Submission and
(3) the Archives' Authorship Form & Copyright Assignment Disclosure for
Submission of a Revised Paper.
During original submission, the corresponding author completes and uploads
both the Authorship Form for Original Submission and theICMJE form. If a
revised paper is submitted, all authors complete both the Authorship Form for
Revised Paper and the ICMJE form.
Authors must choose one (or both*) of the following statements:
We certify that no party having a direct interest in the results of the
research supporting this article has or will confer a benefit on us or on any
organization with which we are associated AND, if applicable, we certify
that all financial and material support for this research (eg, NIH or NHS
grants) and work are clearly identified in the title page of the manuscript.
(List author(s)' names here*)
We certify that we have affiliations with or financial involvement (eg,
employment, consultancies, honoraria, stock ownership or options, expert
testimony, grants and patents received or pending, royalties) with an
92
organization or entity with a financial interest in, or financial conflict with,
the subject matter or materials discussed in the manuscript AND all such
affiliations and involvements are disclosed on the title page of the
manuscript. (List each author(s)' affiliation or financial involvement in a
statement following this certification.)
*Conflict of Interest
If one statement is appropriate for one or more authors of a group and the other
statement is appropriate for the other authors, include both statements and list
the last names of the authors in parentheses following the appropriate
statement. For the statement certifying a possible conflict of interest, each
affected author should detail the specific relationship on the title page.
Please see the ICMJE definition of conflicts of interest (
http://www.icmje.org/ethical_4conflicts.html). It is important to note that a
conflict of interest can be actual or perceived.
Open Access
Archives offer the option for authors to sponsor (open) access to their individual
articles via arrangements with funding bodies. These options enable authors to
decide how their articles are published and to comply with the requirements of
institutions, governments and funding bodies.
Authors can only select this option after receiving notification that their article
has been accepted for publication.
To understand more about this option for open access, please click here.
To provide Open Access, this journal has a publication fee which needs to be
met by the authors or their research funders for each article published Open
Access. Your publication choice will have no effect on the peer review process
or acceptance of submitted articles. The Open Access publication fee for this
journal is USD $3000.00, excluding taxes.
EDITORIAL PROCESS
Original Submissions
Manuscripts are submitted through the journal's online system (
http://ees.elsevier.com/archives-pmr). The review process will not begin until
authors have complied completely with the submission requirements.
93
Compliance includes submission of separate documents in the following order:
(1) cover letter; (2) title page, including acknowledgments and explanation of
any conflicts of interest; (3) main text file (manuscript without author identifiers)
including a structured or standard abstract, keywords, list of abbreviations, body
of the text, references, suppliers’ list, figure legends; (4) figures; (5) tables; (6)
appendices; (7) supplementary files; (8) checklist; (9) disclosure forms (ICMJE
Form for Disclosure of Potential Conflicts of Interest and the Archives
Authorship Form & Copyright Assignment for Provisional Disclosure at Original
Submission).
Review Process
All submissions will be screened by editors to determine suitability for review.
Manuscripts approved for review will be evaluated by at least 1 recognized
expert in the particular subject matter. Biostatistical review may be obtained.
Peer reviewers' assessments are referred to a member of the Editorial Board,
who may also critique the manuscript. The Editorial Board Member will then
make a decision and communicate with the corresponding author via e-mail.
Decisions are usually communicated no more than 60 days after the manuscript
has been approved for peer review. All reviews are conducted in a double-blind
fashion.
Letters to the editors and editorials are usually evaluated by an editorial
committee; external review may be sought.
Published annually without peer review are the ACRM | American Congress of
Rehabilitation Medicine presidential address and the John Stanley Coulter
Lecture. The Editorial Board does not peer review the published abstracts of
posters, platform presentations of scientific papers, and audiovisual materials
presented at the ACRM annual meeting. Archives also publishes the official
documents of ACRM. These documents are not peer reviewed by Archives and
include position papers and other materials approved by the ACRM.
Revisions
When submitting your revised manuscript, at the request of the Editorial Board,
please include a document, separate from your cover letter, itemizing your
94
response to each of the suggested revisions and any other changes you have
made. Use consecutive line numbering in the text and cite line numbers for
each change. In addition, highlight each change in the revised manuscript. You
will upload this document in the file upload step as the "Detailed Response to
Reviewers." This file should be blinded.
If revisions are not received within the time specified in the decision e-mail, the
manuscript file will be closed. A revision received after a file has been closed
will be handled as a new submission. An extension beyond the deadline may be
granted at the Editorial Board's discretion, but only in extenuating
circumstances, given the editors' commitment to prompt publication.
Submission of a revised manuscript includes submission of separate
documents in the following order: (1) cover letter; (2) title page, including
acknowledgments and explanation of any conflicts of interest; (3) main text file
with highlighted changes, including a structured or standard abstract, keywords,
list of abbreviations, body of the text, references, suppliers’ list, figure legends;
(4) a clean copy of the main text file with no highlighted changes, including a
structured or standard abstract, keywords, list of abbreviations, body of the text,
references, suppliers’ list, figure legends; (5) figures; (6) tables; (7) appendices;
(8) supplementary files; (9) checklist; (10) disclosure forms from each author
(ICMJE Form for Disclosure of Potential Conflicts of Interest and the Archives
Authorship Form & Copyright Assignment Disclosure for Submission of a
Revised Paper. Both forms, individually signed by each author, must be
uploaded with revised papers that received a decision of "Accept Pending
Revisions").
Accepted Manuscripts Policies
All accepted articles will be posted online within 5 business days of release to
production. This posted version will be a PDF of the author's accepted files, will
be submitted to PubMed, and will be fully citable. Supplementary material, such
as raw data, videos, etc., will not be included. Supplementary materials will be
95
included when the article is typeset and published on the Articles in Press
platform or in the monthly print/online issue.
Manuscripts accepted for publication are subject to editing during the production
process. Journal style is based on the AMA Manual of Style. The manuscript
will be typeset and the designated corresponding author will receive page
proofs for approval. Proofs must be returned to Elsevier by the corresponding
author within 48 hours of receipt, as outlined in the e-mail instructions
accompanying the proofs.
All accepted manuscripts become the permanent property
of Archives and may not be published elsewhere without written
permission from the publisher.
Reprints
Reprint order forms are provided to authors by e-mail in a downloadable PDF
format. The reprint form is sent with an e-mail acknowledgment to the author
from Elsevier confirming receipt of the accepted manuscript. Reprint orders
should be submitted within 15 days to ensure delivery within 6 weeks after
publication. Archives does not provide complimentary reprints.
Appeal Process
Authors may appeal a decision to the Editor-in-Chief of Archives. This appeal
must: (1) be submitted in writing, (2) rebut the negative decision, and (3) be
submitted within 30 days after the decision is rendered. Consideration of the
appeal will be based on the appeal letter and the version of the manuscript that
was peer reviewed. The Editor-in-Chief will assign the appeal to an Editorial
Board member for review. The decision from the appeal is final.
PUBLICATION CATEGORIES
96
Articles: Present new and important basic and clinical information, extend
existing studies, or provide a new approach to a traditional subject. Manuscripts
should be limited to 3000 words of text (Introduction through Conclusions).
Figures, tables, and references should be limited to the number needed to
clarify, amplify, or document the text.
Clinical Notes: Report an observation that is interesting, new, or of sufficient
import to warrant attention. Manuscripts should be limited to 3000 words of text
(Introduction through Conclusions); an extensive review of the literature is not
necessary; and references should be limited. One or 2 figures and/or tables
usually suffice to supplement the text.
Brief Reports: Provide preliminary communications of new data, research
methods, brief case studies of interest, new ideas, and techniques. Manuscripts
should be limited to 1500 words of text (or 1200 words plus 1-2 figs or tables,
Introduction through Conclusions), and no more than 10 references.
Commentaries: Focus on issues in physical medicine and rehabilitation.
Manuscripts should be limited to 2000 words of text (Introduction through
Conclusions). The Editorial Board reserves the right to ensure that the author is
qualified, through education and professional experience, to write
knowledgeably and appropriately about a particular subject before accepting a
Commentary for publication. The Editorial Board will choose the author(s) for
invited commentaries and the author(s)' identity will be anonymous until
publication. Authors of the subject article may submit a response for a
subsequent issue.
Review Articles (Meta-Analyses): The Editorial Board invites proposals for
state-of-the-art review articles. Manuscripts should be limited to 5000 words of
text (Introduction through Conclusions), exclusive of references. Authors must
submit financial disclosures at the time of submission. The Archives strongly
prefers systematic reviews of the literature. It is suggested, but not required,
that authors submit their review article topics to the Managing Editor
97
([email protected]) for approval prior to submission.
Clinical Management Reviews: Manuscripts should help rehabilitation
practitioners solve common clinical problems and should focus on clinical
elements commonly seen in rehabilitation practice; they should not contain
research data from previously unreported research, speculation, or extensively
review the literature. Manuscripts should be limited to 3000 words (Introduction
through Conclusions), not more than 30 references, and a maximum of 2 tables
and 4 figures. See instructions for submission below *.
Clinical Implications of Basic Research: Manuscripts should discuss the
clinical implications of basic research in physical medicine and rehabilitation
and develop new concepts that facilitate the understanding and treatment of
disease processes that may impact rehabilitation professionals' practice.
Manuscripts should be limited to 4000 words (Introduction through
Conclusions), exclusive of references. Technical concepts must be explained
succinctly for the technically uninformed. See instructions for submission
below *.
* Instructions for submitting review articles: The Archives
recommends, but does not insist, that authors submit a proposal prior to
submitting a systematic review.
Special Communications: Provide information or an objective analysis of
issues in physical medicine and rehabilitation that does not qualify as a
research or clinical paper or commentary. Manuscripts are peer reviewed and
should be limited to 5000 words of text, exclusive of references.
Editorials: Editorials published in Archives may only be written by the elected
officers of ACRM, or by members of the Editorial Board. Prior to publication, all
editorials are approved by the Editorial Board's Executive Committee. Editorials
do not represent the opinions or positions of ACRM or the Editorial Board.
98
Editorials should be limited to 1000 words of text.
Letters to The Editor: Letters are published at the discretion of the Editorial
Board and should be directly related to the published article on which it
comments. Letters may not reference unpublished studies or reference "in
press" studies that are not publicly available. The editorial staff reserves the
right to solicit a response from the authors of the cited paper as well as
condense and edit without consulting the writer. Letters must be limited to
roughly 500 words of text, 1 table, and no more than 5 references.
MANUSCRIPT PREPARATION
Authors should prepare manuscripts according to the "Uniform Requirements
for Manuscripts Submitted to Biomedical Journals" 1 as developed by the
International Committee of Medical Journal Editors. The Requirements are
available at http://www.icmje.org.
Document Formatting
Manuscripts must be double-spaced throughout, including the title page,
abstract, text, acknowledgments, references, individual tables, and legends.
Use only standard 12-point type and spacing. Use unjustified, flush-left margins.
Number the pages of the text consecutively. Put the page number in the upper
or lower right-hand corner of each page. Number each line on each page of the
text to facilitate peer review.
Authors should format manuscripts for specific attributes such as italics,
superscripts/subscripts, and Greek letters. The coding scheme for each such
element must be consistent throughout the file.
Text Style:
Enter only 1 space between words and sentences
Leave 1 blank line between paragraphs
99
Leave 2 blank lines between headings and text
Cover Letter Document
The cover letter should include essential information, including who the
corresponding author will be and a statement signed by the corresponding
author that written permission has been obtained from all persons named
in the Acknowledgments and patient consent forms have been collected, if
needed.
Title Page Document
These elements are in the following sequence and are double-spaced.
Running head of no more than 40 character spaces.
Title.
Author(s) full name(s) and highest academic degree(s).
The name(s) of the institution(s), section(s), division(s), and
department(s) where the study was performed are provided and the
institutional affiliation(s) of the author(s) at the time of the study are
indicated. An asterisk after an author's name and a footnote may indicate a
change in affiliation.
Acknowledgment of any presentation of this material, to whom, when,
and where.
Acknowledgment of financial support, including grant numbers.
Any other needed acknowledgments.
Explanation of any conflicts of interest.
Name, address, business and home telephone numbers, and e-mail
address of corresponding author and the author from whom reprints can be
obtained.
If reprints are not available, this is stated on the title page.
Clinical trial registration number, if applicable.
Acknowledgments
One or more statements should specify: (1) contributions that do not justify
100
authorship (ie, third-party statistical analysis, writing/editing); and (2)
acknowledgments of technical help.
Persons who have contributed intellectually to the manuscript but whose
contributions do not justify authorship must be named and their function or
contribution described, eg, "scientific adviser," "critical review of study
proposal," "data collection," or "participation in clinical trial." [Please note: we
do not include participants/subjects of the study.] Such persons must give
permission to be named. Authors are responsible for obtaining written
permission from persons acknowledged by name because readers may infer
their endorsement of the data and conclusions.
Clerical, administrative, and laboratory staff should not be acknowledged,
unless they have contributed significantly to the research, writing, or intellectual
quality of the article. Main Text Document (manuscript withou author
identifiers)
Editorial Guidelines for Preparation
Archives uses a double-blind peer-review process. The blinded
submission should be submitted in a word document and should begin with
a title followed by the abstract, keywords, list of abbreviations, body of
the text, references, figure legends, andsuppliers' list.
This document is consecutively line numbered.
If this is a randomized controlled trial, provide the CONSORT flow
diagram.
Statement is included in the body of the manuscript that human
experimentation has been approved by the local institutional review board
or conforms to Helsinki Declaration, as stated in the section Manuscript
Preparation, Methods.
Guidelines for the care/use of nonhuman animals or other species,
approved by the institution, have been followed as indicated in the
Methods. The species is named in the title, abstract, and Methods section.
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It is recommended that a professional editor or a colleague fluent in
English edit the manuscript before submission for authors whose first
language is not English.
Sections & headings: The body of the manuscript includes the
Introduction (no heading needed), Methods, Results, Discussion, Study
Limitations (subheading), and Conclusions headings. Longer articles may
need other subsection headings to clarify their content, especially the
Results and Discussion sections. Clinical Notes articles include the
headings: Case Description, Discussion, and Conclusions. Clinical
Management Reviews articles include the headings: Summary of Pertinent
Research, Therapeutic Approach, and Conclusions. Other types of articles
such as Commentaries and Special Communications do not require this
format.
Footnotes other than for references are not allowed in the manuscript
body.
Trade Names. No trade names (i.e., trademarked of non-generic names
of commercially available products/services) are permitted prior to the
Methods section, including in the article title or abstract.
Elements of Main Text Document
Abstract
For Articles reporting original data (Article; Brief Reports) and Review Articles
(including Meta-Analyses), see the Instructions for Structured Abstracts. For
other manuscripts (eg, Clinical Management Reviews, Clinical Implications of
Basic Research, Clinical Notes, Commentaries, Special Communications),
include a conventional, unstructured abstract of no more than 250 words.
Key Words
Accompanying all abstracts, authors must provide 3 to 5 Key Words. Key words
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must be selected from the US National Library of Medicine's (NLM) Medical
Subject Headings, which is available at
http://www.nlm.nih.gov/mesh/MBrowser.html.
Abbreviations
Archives' editorial policy is to minimize the use of abbreviations. Fewer
abbreviations make it easier for the multidisciplinary readership to follow the
text. Authors should include a list of abbreviations in their manuscript file
following the abstract (just above introduction).Archives uses only standard
abbreviations with Davis's and Dorland's as our guides. Abbreviations that are
used only in tables, appendices, or figures are not included in the list and
should be defined in the table, appendix, or figure note; however, abbreviations
that are in the list need not be re-defined in a table footnote or legend. All
abbreviations must be defined on first mention in the body of the manuscript.
The abbreviations SD (standard deviation) and SE (standard error) require no
definition in Archives. Headings
Methods, Results, Discussion, and Conclusions. Articles should include the
subsection heading Study Limitations at the end of the Discussion section.
Longer articles may need other subsection headings to clarify their content,
especially the Results and Discussion sections.
Clinical Notes headings: Case Description, Discussion, and Conclusions.
Clinical Management Reviews headings: Summary of Pertinent Research,
Therapeutic Approach, and Conclusions.
Other types of articles such as Commentaries and Special Communications do
not require this format.
Introduction
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State the purpose of the article. Summarize the rationale for the study or
observation. Give only pertinent references, and do not review the subject
extensively. Do not include data or conclusions from the work being reported.
Do not include a heading for this section.
Methods
Describe the selection of the observational or experimental subjects (patients or
experimental animals, including controls) clearly. Discuss eligibility of
experimental subjects. Give details about randomization. Describe the methods
for any blinding of observations. Identify the methods, equipment and materials,
and procedures in sufficient detail to allow others to reproduce the results.
Reference established methods, including statistical methods (see below);
provide very brief descriptions for methods that have been published but are not
well known; describe new or substantially modified methods, give reasons for
using them, and evaluate their limitations. Identify precisely all drugs and
chemicals used, including generic name(s), dose(s), and route(s) of
administration.
While there may be occasional exceptions, the Archives is committed to the
need for clinical trial reports to be accompanied by adequate periods of follow-
up. A lack of sufficient follow-up may be detrimental to a paper's acceptance.
When reporting work with human subjects, indicate whether the procedures
followed protocol and accord with the ethical standards of the responsible
institutional review board, ethics committee or with the Helsinki Declaration of
1975, as revised in 1983, as appropriate for the country where the research
took place.2
Do not use patients' names, initials, or hospital numbers, especially in any
illustrative material. When reporting experiments on animals, indicate whether
the procedures followed accord with the institution's committee on animal
experimentation or with the National Research Council's guide on the care and
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use of laboratory animals. Archives may require authors to verify the above
procedures.
Describe statistical methods in enough detail to enable knowledgeable readers
with access to the original data to verify the reported results. When possible,
quantify findings and present them with appropriate indicators of measurement
error or uncertainty (eg, confidence intervals [CIs]). Avoid sole reliance on
statistical hypothesis testing, such as P values, which fails to convey important
quantitative information.
Researchers should report and identify the specific statistical test used and the
obtained statistical value. Researchers should supplement the results of any
statistical value. Researchers should supplement the results of any statistical
significance test with the use of effect size values or CIs. Measures of effect
size or CIs should be routinely included in quantitative clinical trials reported in
rehabilitation research. The statistical power values and the corresponding type
II error probability should always be reported for statistically nonsignificant
results.
The investigator should ensure that there is sufficient power to detect, as
statistically significant, a clinically meaningful treatment effect of an a priori
specified size.3 References for study design and statistical methods should be
to standard works (with pages stated) rather than to papers in which designs or
methods were originally reported.
Specify any general use computer programs used. Avoid nontechnical uses of
technical terms in statistics, such as "random" (which implies a randomizing
device), "normal," "significant," "correlation," or "sample." Define statistical
terms, abbreviations, and symbols.
When submitting manuscripts on randomized controlled trials (RCTs), authors
must include the CONSORT (Consolidated Standards for Reporting Trials) flow
diagram. See the Reporting Guidelines.
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Results
When data are summarized in the Results section, specify the statistical
methods used to analyze them. Describe the success of any blinding of
observations. Report treatment complications. Give numbers of observations.
Report losses to observation (ie, dropouts from a clinical trial). Present results in
logical sequence in the text, tables, and illustrations. Restrict tables and figures
to those needed to explain arguments and to assess their support. Use graphs
as an alternative to tables with many entries; do not duplicate data in graphs
and tables. Do not repeat in the text all the data in the tables, illustrations, or
both; emphasize or summarize only important observations.
While there may be occasional exceptions, the Archives is committed to the
need for clinical trial reports to be accompanied by adequate periods of follow-
up. A lack of sufficient follow-up may be detrimental to a paper's acceptance.
Units of Measurement
Metric units are required. Blood pressures in millimeters of mercury (mmHg)
and all hematologic and clinical chemistry measurements using the International
System of Units (SI).
Discussion
Emphasize the new and important aspects of the study and the conclusions that
follow from them. Do not repeat in detail data or other material given in the
Introduction or the Results section. Include in the Discussion section the
implications of the findings and their limitations, including implications for future
research. Authors should address the issue of effect magnitude, in terms of
both the statistics reported and the implications of the research. Relate the
observations to other relevant studies.
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Study Limitations: Include the subsection, Study Limitations, to discuss the
limitations of the study.
Conclusions: Link the conclusions with the study's goals but avoid unqualified
statements not supported by the data. Avoid claiming priority and alluding to
work that is incomplete. State new hypotheses when warranted, but clearly
label them as such. Recommendations, when appropriate, may be included.
References
References in manuscripts accepted by Archives shall include only material that
is retrievable through standard literature searches. Number references
consecutively in the order in which they first appear in the text. Identify
references in text, tables, and legends by superscript Arabic numerals.
References cited only in tables or in legends to figures should be numbered in
accordance with a sequence established by the first identification in the text of
the particular table or figure.
Use the style of the examples below, which are based on the formats used by
the NLM in MEDLINE. The titles of journals should be abbreviated according to
the style used in MEDLINE. Consult List of Serials Indexed for Online Users,
which is available from the NLM at
http://www.nlm.nih.gov/tsd/serials/lsiou.html.
Try to avoid using abstracts as references; "unpublished observations" and
"personal communications" may not be used as references, although
references to written, not oral, communications may be inserted (in
parentheses) in the text. Avoid "personal communication" unless it provides
essential information not available from a public source. In this case, cite the
name of the person and date of communication in parentheses in the text. For
scientific articles, authors should obtain written permission and confirmation of
accuracy from the source of personal communication.
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Include among the references those papers accepted but not yet published;
designate the journal and add "In press." Authors must obtain written
permission to cite such papers as well as verification that they have been
accepted for publication. Editors will request from the author(s) a copy of the
letter from the journal accepting the "in press" article if the manuscript in which it
is cited is accepted by Archives. Information from manuscripts submitted but
not yet accepted should be cited in the text as "(unpublished observations)" with
written permission from the source.
The references must be verified by the author(s) against the original
documents. List all authors and/or editors for each reference. Do not insert "et
al."
Click here for examples of correct reference formats.
Suppliers
After the References section, provide a Suppliers list with contact information
(names and complete mailing addresses) for manufacturers of devices and
other non-drug products used directly in a study (ie, do not provide such
information for products not directly used in your research but mentioned in
studies you cite). Identify equipment and/or materials in text, tables, and
legends by superscript lower case letters. List suppliers consecutively in the
order they are mentioned in the text.
Manufacturer names and locations should not be listed in the text where the
product is introduced. Do not list Suppliers in theReferences list. Do not list
drug manufacturers in the Suppliers list.
Figure Legends
A list of figure legends should be provided after the reference list and
suppliers' list, listing each figure in order by number.
Legends/captions should not be embedded in the figure files themselves.
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Figures, Images, and Photographs Documents
Preferred file formats are TIFF, EPS, JPEG, and PDF
300 dpi is minimum resolution to achieve high quality images. Typical desired
resolutions are 300 dpi for black and white and color figures; 500 dpi for
combination art (combined photo with line art); and 1,000 dpi for line art.
Figures should be numbered consecutively in the order they are first cited in the
text. If a figure has been published, acknowledge the original source and submit
written permission from the copyright holder to reproduce the material.
Permission is required, irrespective of authorship or publisher, except for
documents in the public domain.
Letters, numbers, and symbols should be clear and even throughout, and of
sufficient size that when reduced for publication each item will still be legible.
Titles and detailed explanations belong in the legends for figures, not on the
figures themselves.
Consistency in size within the article is strongly preferred. Any special
instructions regarding sizing should be clearly noted.
Photomicrographs must have internal scale marker