- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03673319
The Patient Expectation in Dry Needling and Analgesia
The Influence of Patient Expectation in Dry Needling Induced Analgesia
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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-
Madrid
-
Alcala de Henares, Madrid, España, 28871
- Grupo Fisioterapia y Dolor
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Alcalá De Henares, Madrid, España, 28805
- Institut Physiotherapy AND pain
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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"
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Pain Intensity: Visual Analog Scale (VAS)
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Pain Pressure Threshold (PPT)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CEI18/087
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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