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Effectiveness of Dry Needling (DNHS Technique) in Patients With Chronic Stroke

18 de setembro de 2019 atualizado por: Pablo Herrero Gallego, Universidad San Jorge

Study hypothesis:

The DNHS technique, performed via one session of deep dry needling of myofascial trigger points applied to the biceps brachii, brachialis, flexor digitorum superficialis, flexor digitorum profundus, triceps brachii, extensor digitorum and adductor pollicis muscle is effective for decreasing spasticity and muscle stiffness (both of which are components of hypertonia) as well as for improving the upper limb function of the previously described muscles in patients with chronic cerebral vascular accident (CVA), assessed both post-intervention and after 15 days.

General aims

To analyse the immediate therapeutic effect of the DNHS technique and the effect at 15 days follow-up, for the following variables:

  • Spasticity
  • Muscle stiffness
  • Upper limb function
  • Patient perceived quality of life

Materials and methods Population: patients from the province of Zaragoza (Spain) diagnosed with a haemorrhagic or ischemic CVA by a neurologist.

Recruitment strategy: recruitment will take place via the Stroke Association in Aragon (AIDA) [Aragon Stroke Association] in the province of Zaragoza, Spain, seeing as the greater proportion of patients who have suffered a stroke and are in the chronic stage of the illness go to this centre to receive treatment. Thus, this avoids patients having to travel elsewhere for the study. Furthermore, in the case of patients who wish to participate in the study after having received information via third persons or via other means and who are not members of the Association or do not attend the centre on a regular basis, the Association AIDA has offered to allow these people to attend for free, making its facilities available and supporting the development of this study.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

23

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Espanha
      • Zaragoza, Espanha, 50830
        • Universidad San Jorge

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

40 anos a 90 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Patients who have been diagnosed with a haemorrhagic or ischemic CVA by a neurologist.
  • Cognitive level: minimental state examination (MMSE) ≥ 27 points. All patients must have a good cognitive level in order to ensure that they are able to communicate with the professionals involved in the study in order to understand the exercises and thus fulfil the objectives for participation.
  • Presence of spasticity ≥1 according to the Modified Modified Ashworth Scale (MMAS) score during the flexion-extension movement of the wrist and elbow in at least one of the muscles of the upper limb evaluated.
  • Age: between 30 - 90 years. In this range of age CVA's are more common, according to data from the Spanish Statistical Office.
  • Evolution: over 6 months must have passed since the CVA episode. Most of the studies reviewed involve patients who are in the chronic stage of illness. This will ensure that the changes found are due to our intervention and not related to plasticity mechanisms occurring after the injury (this will be considered objectively by performing an assessment at baseline, which will be repeated 1 week later, immediately before and after the dry needling intervention).

Exclusion Criteria:

  • Concomitance of degenerative illnesses which can alter the results.
  • Presence of fixed contractures: 4 according to the MMAS score
  • Suffering from epileptic fits that are not medically controlled.
  • Fear of needles.
  • No tolerance to pain caused by needling.
  • Those unable to commit to attendance.
  • Patients who have received treatment with Botulinum Toxin (BTX A) in the 6 months prior to their inclusion in this study, or those who received said medication or another during the study with the aim of decreasing spasticity.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Dobro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Intervention with DNHS technique
Dry needling of biceps brachii, brachialis, flexor digitorum superficialis and flexor digitorum profundus, triceps brachialis, extensor digitorum and adductor pollicis
Outro: Dry Needling
Dry needling of biceps brachii, brachialis, flexor digitorum superficialis and flexor digitorum profundus, triceps brachialis, extensor digitorum and adductor pollicis
Outros nomes:
  • Técnica de DNS
Comparador Falso: Sham Dry Needling
Sham Dry needling of biceps brachii, brachialis, flexor digitorum superficialis and flexor digitorum profundus, triceps brachialis, extensor digitorum and adductor pollicis
Outro: Sham Dry Needling
Sham Dry needling of biceps brachii, brachialis, flexor digitorum superficialis and flexor digitorum profundus, triceps brachialis, extensor digitorum and adductor pollicis

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Fugl-Meyer Scale
Prazo: Change between baseline (immediately before intervention) and post intervention (immediately after intervention). Change between baseline (immediately before intervention) and follow-up at 2 weeks after intervention
Scale measuring Upper Limb Function in stroke patients. The motor and sensory assessments are scored on a three-point ordinal scale (0 -2) in which a higher score indicates superior results. The motor assessment measures voluntary limb movement and includes a subscale for the Upper Extremity (33 items; score range, 0-66). The sensory assessment measures limb sensation. Sensation is assessed as absent, impaired, or normal for light touch (two items each for Upper Extremity (UE) and Lower Extremity (LE); score range, 0-8) and proprioception (four items each for UE and LE; score range, 0-16) for a total sensory Fugl-Meyer (FM) score of 24. Fugl-Meyer Assessment (FMA) has shown to have an excellent intra and interrater reliability (0.89-0.99). The estimated minimal clinical important difference (MCID) of the UE-FM scores ranged from 4.25 to 7.25 points .
Change between baseline (immediately before intervention) and post intervention (immediately after intervention). Change between baseline (immediately before intervention) and follow-up at 2 weeks after intervention

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Modified Modified Ashworth Scale
Prazo: Change between baseline (immediately before intervention) and post intervention (immediately after intervention). Change between baseline (immediately before intervention) and follow-up at 2 weeks after intervention
Scale measuring Spasticity/Hypertonia. This scale ranges from 0 to 4 points for each muscle assessed, where 0 is no hypertonia/spasticity and 4 is the highest hypertonia/spasticity.
Change between baseline (immediately before intervention) and post intervention (immediately after intervention). Change between baseline (immediately before intervention) and follow-up at 2 weeks after intervention
Electromyography (EMG)
Prazo: Change between baseline (immediately before intervention) and post intervention (immediately after intervention). Change between baseline (immediately before intervention) and follow-up at 2 weeks after intervention
Neurophysiological measurements (electromyographic measurements). The amount of electrical activity will be measured quantitatively, from 0 to an undefined value (depending on every muscle´s activity)
Change between baseline (immediately before intervention) and post intervention (immediately after intervention). Change between baseline (immediately before intervention) and follow-up at 2 weeks after intervention
Tonometry (measurement of muscle tone with a device)
Prazo: Change between baseline (immediately before intervention) and post intervention (immediately after intervention). Change between baseline (immediately before intervention) and follow-up at 2 weeks after intervention
Muscle stiffness or muscle tone. This device register different parameters like frequency, oscillation, etc that are related to tone, and start from 0 to an undefined number (depending on every muscle). It is a quantitative measurement.
Change between baseline (immediately before intervention) and post intervention (immediately after intervention). Change between baseline (immediately before intervention) and follow-up at 2 weeks after intervention
Quality of Life (Euro QoL5D)
Prazo: Change between baseline (immediately before intervention) and follow-up at 2 weeks after intervention
Quality of Life. This scale measures quality of life. Description: This is a measure of self-reported health outcomes. It consists of two parts: a descriptive system (Part I) and a visual analogue scale (VAS) (Part II). Part I of the scale consists of 5 single-item dimensions including: mobility, self care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has a 3 point response scale, ranging from worst imaginable health state to best imaginable health state. Scoring/Interpretation: Descriptive data from the 5 dimensions of Part I can be used to generate a health-related quality of life profile for the subject. Part II is scored from 0 (worst health state imaginable) to 100 (best health state imaginable).
Change between baseline (immediately before intervention) and follow-up at 2 weeks after intervention

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Universidad San Jorge

Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

19 de junho de 2018

Conclusão Primária (Real)

30 de julho de 2018

Conclusão do estudo (Real)

4 de setembro de 2018

Datas de inscrição no estudo

Enviado pela primeira vez

20 de abril de 2018

Enviado pela primeira vez que atendeu aos critérios de CQ

1 de junho de 2018

Primeira postagem (Real)

6 de junho de 2018

Atualizações de registro de estudo

Última Atualização Postada (Real)

20 de setembro de 2019

Última atualização enviada que atendeu aos critérios de controle de qualidade

18 de setembro de 2019

Última verificação

1 de setembro de 2019

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • DNHS_stroke

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

Não

Descrição do plano IPD

Data will be available under request once it is published

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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