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- Ensaio Clínico NCT03673319
The Patient Expectation in Dry Needling and Analgesia
The Influence of Patient Expectation in Dry Needling Induced Analgesia
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Just before DN intervention, participants will receive a positive or a neutral expectation instructional set regarding effects of a DN technique on pain perception. This instructional set will be randomly allocated to each patient.
Participants in the positive expectation group will be told that DN procedure: "is a very effective form of treatment used to treat neck-shoulder pain and it is expected to reduce your perception of pressure pain". Participants in the neutral expectation group will be told that DN procedure: "is a form of treatment used to treat neck-shoulder pain that has unknown effects on your perception of pressure pain".
DN intervention An experienced and trained physical therapist will provide DN to all the subjects. This researcher will be blinded to the specific expectation instructional set the participant receives. Participants will receive one session of DN treatment for the active Myofascial Trigger Points(MTrP) located at the upper trapezius muscle. They will be placed in a prone position on the examination table. Solid filament needles of 0.30 mm diameter and 40 mm length will be used. The needle will be inserted into the skin over the palpated MTrP using pincer palpation, and slowly advanced perpendicularly until it reaches the MTrP and a twitch response is elicited.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Madrid
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Alcala de Henares, Madrid, Espanha, 28871
- Grupo Fisioterapia y Dolor
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Alcalá De Henares, Madrid, Espanha, 28805
- Institut Physiotherapy AND pain
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-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- neck pain (≥3 months of duration)
- VAS of 4-5 of pain.
- Presence of at least one active MTrP located at the upper trapezius.
Exclusion Criteria:
- Patients with previous cervical spine or shoulder surgery.
- Cervical spine radiculopathy or myelopathy.
- Systemic disease.
- Fibromyalgia.
- Pregnancy.
- Using sedative drugs.
- Needle phobia.
- Bleeding disorder.
- anticoagulant medication.
- Previous experience with DN for myofascial pain.
- Skin lesion and infection or inflammatory oedema at the MTrPs site
Plano de estudo
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: Positive expectative
Participants in the positive expectation group will be told that DN procedure: "is a very effective form of treatment used to treat neck-shoulder pain and it is expected to reduce your perception of pressure pain"
|
DN procedure: "is a very effective form of treatment used to treat neck-shoulder pain and it is expected to reduce your perception of pressure pain"
|
|
Experimental: Neutral expectatives
Participants in the neutral expectation group will be told that DN procedure: "is a form of treatment used to treat neck-shoulder pain that has unknown effects on your perception of pressure pain"
|
DN procedure: "is a form of treatment used to treat neck-shoulder pain that has unknown effects on your perception of pressure pain"
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Pain Intensity: Visual Analog Scale (VAS)
Prazo: Change from Baseline at after intervention
|
The investigators use a Visual Analog Scale (VAS) to determine the intensity of the patient's current pain before, during DN and immediately after DN.
We will follow the paradigm of Conditioned pain modulation (CPM) paradigm.
CPM will be induced by inflating an occlusion cuff (conditioning stimulus) at the arm, at the opposite side from the affected upper trapezius.The VAS is a 100-mm line, oriented horizontally, with one end representing "no pain"(the best value) and the other end representing "worst pain" (the worse value).
Subjects will be asked to rate their current pain with a mark on the scale.
|
Change from Baseline at after intervention
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Pain Pressure Threshold (PPT)
Prazo: Change up 1 hour
|
The PPT serves to determine the sensitivity of hiperalgesic focus. The investigators will done it with one algometer. Lower values are a worse result. Higher values are a better result. |
Change up 1 hour
|
|
Dry needling pain
Prazo: Change up 1 hour
|
The investigators use a Visual Analog Scale (VAS) to determine the intensity of the patient's pain during DN intervention.The VAS is a 100-mm line, oriented horizontally, with one end representing "no pain" (the best value) and the other end representing "worst pain" (the worse value).
Subjects will be asked to rate their current dry needling pain with a mark on the scale.
|
Change up 1 hour
|
|
Dry needling anxiety
Prazo: Change up 1 hour
|
The investigators use a Visual Analog Scale (VAS) to determine the anxiety of the patient during DN.The VAS is a 100-mm line, oriented horizontally, with one end representing "no anxiety"(the best value) and the other end representing "worst anxiety"(the worse value).
Subjects were asked to rate their current dry needling anxiety with a mark on the scale
|
Change up 1 hour
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- CEI18/087
Plano para dados de participantes individuais (IPD)
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Descrição do plano IPD
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