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Osteopathic Manipulative Treatment and Its Relationship to Autonomic Nervous System Activity

21 de agosto de 2008 actualizado por: University of Oklahoma

Osteopathic Manipulative Treatment and Its Relationship to Autonomic Nervous System Activity as Demonstrated by Heart Rate Variability

The relationship between Osteopathic Manipulative Therapy (OMT) and the autonomic nervous system is poorly understood. This study quantifies that relationship and demonstrates a cause and effect. It is hypothesized that cervical myofascial release increases vagal tone.

Descripción general del estudio

Estado

Terminado

Condiciones

Descripción detallada

For most osteopathic physicians the validation of osteopathic manipulative treatment (OMT) has been largely observational and based on patient outcomes such as improvement in pain scales, range of motion, and other empiric measures.1,2 However, the osteopathic profession has long recognized a relationship between the autonomic nervous system and the function of the body in health and disease, although there is relatively little quantitative data evaluating the relationship between manipulation and the autonomic nervous system.3,4

A theoretical basis for the action of OMT and its effect in the body has been advanced based on autonomic activation causing concomitant vasodilatation, smooth muscle relaxation, and increased blood flow, resulting in improved range of motion, decrease in pain perception, or change in tissue. Until recently this association remained largely a theoretical consideration due to the inability to accurately measure autonomic activity directly. Over the past two decades indirect methods have been developed and refined to provide noninvasive markers of autonomic balance,5,6 with heart rate variability (HRV) being commonly used. HRV is based on the inherent variation of the R-to-R intervals of a standard electrocardiogram (ECG), with these variations largely due to changes in autonomic balance at the sinus node.6-8

Spectral analysis of heart rate variability has been used to study autonomic balance in humans, and it is generally accepted that the high frequency (HF) component (0.15-0.4 Hz) can be used as a marker for vagal modulation of heart rate. Although it is tempting to use the low frequency (LF) component (0.04-0.15 Hz) as a marker for sympathetic activity, its specificity is less clear. Pagani and colleagues9,10 have hypothesized that when the LF component is expressed in normalized units (LFnu) it becomes a better marker of sympathetic modulation of heart rate. For most studies using spectral analysis, the LF/HF ratio is used and considered by many to be a good index of sympathovagal balance.6,7,9,10

The confidence given to the LF/HF ratio accurately reflecting autonomic balance is significantly influenced by experimental design. A tilt protocol involving postural change from horizontal to upright can be used to calibrate the change in the LF/HF ratio which occurs between the two positions and thus set a physiological range for sympathetic and vagal modulation of heart rate. An experimental procedure then can be implemented where comparisons are made of the changes in the LF/HF ratios that occur when the body is shifted from the horizontal to the upright position under conditions with application of an intervention versus without the intervention. In this manner, an experimentally mediated change in LF/HF ratio (i.e., with intervention) can be calibrated against a physiologically relevant change in ratio (i.e., without intervention).

This approach was used by these investigators in a pilot study (n=9 healthy, adult volunteers, 3 females and 6 males) which showed that the LF/HF ratio changed from a mean of 1.75+1.40 (mean+SD) in the horizontal position to a mean of 6.00+1.20 in the 50-degree head-up position. This change reflects an increase in sympathetic tone. Mean heart rate in these subjects increased from 61+7 bpm to 78+2 bpm in the head-up position. The subjects then were treated in the 50-degree head-up position with an OMT procedure, cervical myofascial release, which is thought to increase vagal tone. After the procedure was applied, the LF/HF ratio decreased back down to 1.75+1.58, even though the subjects were still in the head-up position. These data support the initial hypothesis that specific OMT procedures can modulate vagal tone, and also provide information relating to the significance of the LF/HF change. That is, the application of OMT reversed the increase in the ratio that occurs in the 50-degree head-up position.

We conducted a continuation project to further examine the association between OMT and autonomic nervous system activity as demonstrated by HRV, studying the hypothesis that cervical myofascial release increased vagal tone. In a within subjects (repeated measures) design, we examined the effect of OMT on HRV in comparison with sham treatment (touch only) and control (no touch) conditions.

Tipo de estudio

Intervencionista

Inscripción (Actual)

30

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

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 50 años (Adulto)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

Twenty-eight (28) study subjects then were selected by their response to a general questionnaire, which indicated suitability for the study, and assessed by the following inclusion criteria:

  • written informed consent
  • normal healthy adults older than 19 years and younger than 50 years
  • normal ECG
  • normal blood pressure based on criteria published in the Seventh Report of the U.S. Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC-7).

Exclusion Criteria:

  • Exclusion criteria included chronic cardiovascular disease (heart failure, myocardial infarction, or hypertension)
  • diabetes
  • asthma
  • pregnancy
  • smoking
  • premature ventricular contractions exceeding 20% of total heart beats
  • resting supine heart rate greater than 75 bpm or less than 45 bpm, systolic blood pressure greater than 140 mmHg or less than 90 mmHg
  • failure of heart rate to increase with passive tilt (50-degrees head-up)
  • Long-distance runners and other conditioned athletes also were excluded

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: No aleatorizado
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador de placebos: Placebo
No-touch control condition applied while subject was at a 50-degree head-up tilt.
No-touch control condition applied while subject was at a 50-degree head-up tilt.
Comparador falso: Sham
Touch-only sham treatment applied while subject was at a 50-degree head-up tilt.
Touch-only sham treatment applied while subject was at a 50-degree head-up tilt.
Comparador activo: OMT
Cervical myofascial OMT applied while subject was at a 50-degree head-up tilt.
Cervical myofascial OMT applied while subject was at a 50-degree head-up tilt.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Normalized low frequency and high frequency components of HRV, including LF/HF ratio. Comparisons between measurements taken at a 50-degree tilt with those taken at pre- and post-intervention in the horizontal position.
Periodo de tiempo: Treatments administered in separate sessions at least 24 hours apart.
Treatments administered in separate sessions at least 24 hours apart.

Colaboradores e Investigadores

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

Patrocinador

Investigadores

  • Investigador principal: Charles E. Henley, D.O., MPH, OUHSC
  • Investigador principal: Frances Wen, Ph.D., OUHSC
  • Investigador principal: Bruce Benjamin, Ph.D., OSU
  • Investigador principal: Douglas Ivins, M.D., OUHSC
  • Investigador principal: Miriam Mills, M.D., OSU

Publicaciones y enlaces útiles

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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

1 de enero de 2005

Finalización del estudio (Actual)

1 de octubre de 2007

Fechas de registro del estudio

Enviado por primera vez

15 de agosto de 2007

Primero enviado que cumplió con los criterios de control de calidad

15 de agosto de 2007

Publicado por primera vez (Estimar)

16 de agosto de 2007

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

22 de agosto de 2008

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

21 de agosto de 2008

Última verificación

1 de agosto de 2008

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • OUIRB 12024

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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