Neurophysiologic Effects of Cervical Spinal Manipulation in Asymptomatic Individuals
12 de marzo de 2018 actualizado por: Nuno Filipe Pinho Nogueira, Escola Superior de Tecnologia da Saúde do Porto
This study had the goal of analyse the neurophysiologic effects of both mechanical and manual cervical manipulation, in asymptomatic individuals.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
In this study, the investigators compared the effects of manual manipulation and instrument assisted manipulation of C3/C4 on muscle tone, elasticity and stiffness and on pressure pain threshold , and pressure pain perception.
The muscles evaluated were upper trapezius and biceps brachialis, bilaterally.
The study also had a placebo and a control group.
All individuals were asymptomatic.
Tipo de estudio
Intervencionista
Inscripción (Actual)
59
Fase
- No aplica
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Healthy subjects.
- Minimum of 18 years old.
Exclusion Criteria:
- Pain in cervical region, shoulders or arms.
- History of trauma or disease in the cervical region or upper limb.
- Use of medication that could affect the outcomes (painkillers, NSAID, or anti depressives) during the last week.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Manual manipulation
In the Manual manipulation group, the thrust was applied in the right side of C3/C4 with neutral flexion/extension, ipsilateral side bending and contralateral rotation.
Then, a low amplitude, high velocity thrust in rotation was delivered.
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In the Manual manipulation group, the thrust was applied in the right side of C3/C4 with neutral flexion/extension, ipsilateral side bending and contralateral rotation.
Then, a low amplitude, high velocity thrust in rotation was delivered.
|
|
Comparador activo: Mechanical manipulation
In the Mechanical manipulation group, the Activator instrument was applied on the right transverse apophyses of C3.
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In the Mechanical manipulation group, the Activator instrument was applied on the right transverse apophyses of C3.
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Comparador de placebos: Placebo
The subjects were positioned in the same pre-manipulative position as the manual manipulation group, but the thrust didn't occur.
Instead, the position was hold for 3 seconds and then the subject's head returned passively to neutral position.
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The subjects were positioned in the same pre-manipulative position as the manual manipulation group, but the thrust didn't occur.
Instead, the position was hold for 3 seconds and then the subject's head returned passively to neutral position.
|
|
Sin intervención: Control
The subjects stayed in supine position and no intervention occurred.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Pressure pain thresholds
Periodo de tiempo: Immediately after the intervention
|
To measure the pressure pain threshold, it was used an electronic pressure dynamometer FORCE ONE™ FDIX (Wagner Instruments - Greenwich, USA), with 1cm2 of surface.
The values were expressed in Kg/cm2.
The pressure was increased at a rate of 1 kg/cm2/s until the subject inform that the sense of pressure has become a sense of pain.
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Immediately after the intervention
|
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Pressure pain perception
Periodo de tiempo: Immediately after the intervention
|
To evaluate the pressure pain perception, it was used a Visual Analogue Scale (VAS).
The pressure increased until 2,5 kg/cm2 and was hold for 5 seconds, and the subject used the VAS scale to record the pressure pain perception he felt.
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Immediately after the intervention
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Muscle tone
Periodo de tiempo: Immediately after the intervention
|
To measure muscle tone it was used the MyotonPro device.
It was used to evaluate those parameters both on the biceps and on the upper trapezius, bilaterally.
The device was located perpendicular to the middle point of each muscle and it were recorded 6 impulses in each one of them.
The non-neural tone was recorded as frequency.
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Immediately after the intervention
|
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Muscle stiffness
Periodo de tiempo: Immediately after the intervention
|
To measure muscle stiffness it was used the MyotonPro device.
It was used to evaluate this parameter both on the biceps and on the upper trapezius, bilaterally.
The device was located perpendicular to the middle point of each muscle and it were recorded 6 impulses in each one of them.
The muscle stiffness was recorded as N/m.
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Immediately after the intervention
|
|
Muscle elasticity
Periodo de tiempo: Immediately after the intervention
|
To measure muscle elasticity it was used the MyotonPro device.
It was used to evaluate those parameters both on the biceps and on the upper trapezius, bilaterally.
The device was located perpendicular to the middle point of each muscle and it were recorded 6 impulses in each one of them.
The elasticity was indicated by logarithmic decrement.
|
Immediately after the intervention
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Nuno Nogueira, MSc, Instituto Politécnico da Saúde do Norte
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de mayo de 2013
Finalización primaria (Actual)
1 de julio de 2014
Finalización del estudio (Actual)
1 de octubre de 2016
Fechas de registro del estudio
Enviado por primera vez
8 de septiembre de 2017
Primero enviado que cumplió con los criterios de control de calidad
10 de marzo de 2018
Publicado por primera vez (Actual)
13 de marzo de 2018
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
14 de marzo de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
12 de marzo de 2018
Última verificación
1 de marzo de 2018
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- 20122017
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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