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Acupuncture Outcomes Based Rehabilitation

3 de marzo de 2018 actualizado por: Community Medical Foundation for Patient Safety

Acupuncture Outcomes Based Rehabilitation Through Measurement of Fine Motor Control

Can acupuncture be quantified. This study sets out to observe if there are measurable effects of fine motor control that are attributable to acupuncture. The study utilizes an FDA approved medical device for measurements of fine motor control called the RU-Fit.

Descripción general del estudio

Estado

Terminado

Condiciones

Descripción detallada

Context: Currently there is a high demand for evidence-based research in the field of Acupuncture. The medical practice of acupuncture has existed for thousands of years and purportedly has been successful at managing a wide array of health conditions. Producing objective/quantitative data that rule out any possibility of placebo effect has proved burdensome.

Objectives: This exploratory study seeks to determine if physiological measurements of fine motor control can be changed after receiving an acupuncture treatment. Can this change demonstrate the effectiveness of the treatment? Design, Setting, Participants, Interventions: This study looked at acupuncture patients undergoing treatments for pain relief, and general minor injury to determine whether or not observable changes could be detected in the fine motor control of the hands after acupuncture treatments.

Two groups of 50 subjects were used in the study. The test group was given a fine motor control test prior to and after their acupuncture therapy to determine if any changes could be measured.

The control group was given two fine motor control tests without acupuncture treatment with a 40 minute delay between the tests to replicate the test group timing. This study was conducted at a non-profit community clinic between the dates of 9/28/16 & 2/19/17.

Tipo de estudio

De observación

Inscripción (Actual)

100

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

13 años y mayores (Niño, Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

Study participants were selected from the acupuncture patient population freely visiting the clinic. Patients were asked if they would be interested in a research study. They were informed about the objectives of the study, what their role would be and that this was a free non-invasive test that they would undergo before and after their regular acupuncture treatment. Before inclusion into the program, patients are provided with informed consent forms and after agreeing and signing the form, individuals then become participants.

Descripción

Inclusion Criteria:

  • Male or female 13 years old or older
  • Study participants were selected from the acupuncture patient population freely visiting the clinic. Patients were asked if they would be interested in a research study. They were informed about the objectives of the study, what their role would be and that this was a free non-invasive test that they would undergo before and after their regular acupuncture treatment. Before inclusion into the program, patients are provided with informed consent forms and after agreeing and signing the form, individuals then become participants.

Exclusion Criteria:

  • Younger than 13 years old

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

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
Acupuncture Intervention group
RU-Fit gathers measurements of fine motor control were gathered from this group before and after acupuncture treatments.
Alternative medicine therapeutic intervention
FDA approved medical device for the measurement of fine motor control
Control/ Non-Intervention
This group received no intervention but still had measurements of fine motor control gathered from RU-Fit medical device.
FDA approved medical device for the measurement of fine motor control

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Assessing Changes in Fine Motor Control from Acupuncture
Periodo de tiempo: Before and after acupuncture treatment or space of 40 minutes for control group between testing
Fine Motor Control measurements (probability percentage of normal capability) from RU-Fit, FDA approved medical device
Before and after acupuncture treatment or space of 40 minutes for control group between testing

Colaboradores e Investigadores

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

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)

28 de septiembre de 2016

Finalización primaria (Actual)

21 de enero de 2017

Finalización del estudio (Actual)

19 de febrero de 2017

Fechas de registro del estudio

Enviado por primera vez

26 de febrero de 2018

Primero enviado que cumplió con los criterios de control de calidad

3 de marzo de 2018

Publicado por primera vez (Actual)

9 de marzo de 2018

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

9 de marzo de 2018

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

3 de marzo de 2018

Última verificación

1 de marzo de 2018

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • RU-Fit Acu 1

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

Information will be shared regarding measurements that were obtained from medical device testing such as fine motor control

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.

producto fabricado y exportado desde los 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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