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Influence of Oral Messages on the Activity of Wrist and Finger Flexor Muscles

8 de agosto de 2022 actualizado por: Kamil Zaworski, John Paul II University of Applied Sciences in Biala Podlaska

Influence of Oral Messages on the Activity of Wrist and Finger Flexor Muscles - in the Context of Application of Sham Therapy

The aim of the study will be to evaluate the effect of oral messages on wrist and finger flexor muscle activity during the application of sham therapy in the form of paper plaster.

For years, research has been conducted on the effects of dynamic plaster and rigid plaster on muscle function. In many cases, reports from different authors are contradictory. Therefore, the planned study will use placebo paper plaster with no proven therapeutic effect.

Descripción general del estudio

Descripción detallada

People's words can have a huge impact on how we interpret our surroundings, what we expect and experience, and how we behave. The placebo (and nocebo) effects are a clear example here. The way health professionals discuss, describe and inform patients about the characteristic effects of a given disease, its prevention, diagnosis and treatment influences patients' feelings and expectations, which in turn affects their psychobiological responses, subjective feelings and treatment outcomes.

The right choice of words by clinicians influences patients' response to medical treatments and procedures, both active and sham. The way in which information about the effects of treatment is communicated to patients can reinforce the outcomes of a particular treatment (placebo) or reverse clinically-proven effects of an active treatment, or even increase its adverse effects. The right messages can reduce the nocebo effect. And vice versa, the wrong choice of information provided may increase the patient's anxiety and disease symptoms.

The aim of the study will be to evaluate the effect of oral messages on wrist and finger flexor muscle activity during the application of sham therapy in the form of paper plaster.

Main hypothesis:

The use of a positive message will have an effect on increasing the activation and strength of the flexor muscles of the wrist joint and fingers.

Research questions:

  1. Does a positive message have an effect on increasing the activation and strength of the flexor muscles of the wrist joint and fingers?
  2. Does a negative message have an effect on increasing the activation and strength of the flexor muscles of the wrist joint and fingers? Does a neutral message have an effect on increasing the activation and strength of the flexor muscles of the wrist joint and fingers?

The study will be a prospective, flow-up study using a differential variable in the form of the type of message used (positive - placebo, negative - nocebo, neutral). The respondents will be randomly allocated to study groups using sealed allocation sheets.

Before taking part in the study, each subject will be familiarised with the course of the study and must give written informed consent to participate in the study and to be randomly assigned to a specific study group.

The subjects will be assessed twice - before applying a paper plaster and 10 minutes after applying the plaster and delivering a voice message.

Tipo de estudio

Intervencionista

Inscripción (Actual)

90

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

      • Biała Podlaska, Polonia, 21-500
        • Pope John Paul II State School Of Higher Education in Biała Podlaska

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

19 años a 24 años (Adulto)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • subjects not using non-steroidal anti-inflammatory drugs (NSAIDs) for at least one week prior to study entry,
  • age - 19-24 years,
  • written consent to participate in the study.

Exclusion Criteria:

  • subjects studying for a degree in physiotherapy,
  • subjects post surgery on the examined upper limb,
  • subjects with past bone fractures in the examined upper limb,
  • subjects who have had an injury to the examined upper limb within 6 months before the start of the study.

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: Ciencia básica
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Positive message
Group A - 30 subjects who will be told that positive message.
Subjects who will be told that "the applied plastering method significantly increases muscle strength" (positive message - placebo).
Experimental: Negative message
Group B - 30 subjects who will be told negative message.
Subjects who will be told that "the applied plastering method has no effect on muscle strength" (negative message - nocebo).
Experimental: Neutral message
Group C - 30 people who will be told neutral message.
Subjects who will be told that "the applied plastering method is currently under investigation and the investigators do not know its effects" (neutral message).

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Dynamometer tests
Periodo de tiempo: Change in measured parameters 10 minutes after application of the plaster and delivery of the oral message relative to baseline measurement.
Assessment of wrist and finger flexor muscle strength. Patient in sitting position with the elbow joint on the examined side bent and the forearm resting on the table. The patient squeezes the dynamometer for a period of 3-5 seconds.
Change in measured parameters 10 minutes after application of the plaster and delivery of the oral message relative to baseline measurement.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Testing with Naroxon Ultimum EMG
Periodo de tiempo: Change in measured parameters 10 minutes after application of the plaster and delivery of the oral message relative to baseline measurement.

Assessment of wrist and finger flexor muscle activity. Patient in sitting position with the elbow joint on the examined side bent and the forearm resting on the table. The subject's arm is adducted, the wrist joint in an intermediate position. The electrodes are glued in the belly area of the flexor muscles of the wrist and fingers - about 2 cm from the medial epicondyle of the humerus in a distal direction at a distance of 1 cm from each other.

The patient squeezes the dynamometer for a period of 3-5 seconds.

Change in measured parameters 10 minutes after application of the plaster and delivery of the oral message relative to baseline measurement.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Silla de estudio: Kamil Zaworski, FIZJOPERFEKT Kamil Zaworski

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 diciembre de 2021

Finalización primaria (Actual)

30 de abril de 2022

Finalización del estudio (Actual)

8 de agosto de 2022

Fechas de registro del estudio

Enviado por primera vez

28 de diciembre de 2021

Primero enviado que cumplió con los criterios de control de calidad

11 de enero de 2022

Publicado por primera vez (Actual)

25 de enero de 2022

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

10 de agosto de 2022

Última actualización enviada que cumplió con los criterios de control de calidad

8 de agosto de 2022

Última verificación

1 de agosto de 2022

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • PopeJohnPaulIIStateSchHigherE3

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

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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