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Completed

NCT Number: NCT04234958

Short- and Long-term HRV Measurements After Osteopathic Myofascial Thoracic Manipulations

The adaptation of the heart to react to any stimulus is called heart rate variability (HRV). Moreover, HRV is now used as a health index. In fact, among the pathologies affecting HRV the most, there are the cardiovascular diseases and depressive disorders that take a predominant part in the investigator's actual societies, According to a recent literature overview, many factors influence HRV and they need to be determined in order to plan efficient research protocols. Moreover, the control of these factors can improve the HRV and therefore help the heart to have maximum capacity to fulfill its physiological functions. Valorizing a good HRV seems, according to the effects reported by several studies, to be a good opportunity to take into consideration and to apply.

Visceral osteopathy, even if it goes back to the founder of Osteopathy himself, Andrew Taylor Still, is at its debuts in terms of acknowledgement from a scientific point of view. The evidence of efficacy of osteopathy is not to be done anymore. However, it is now necessary to define the action mechanisms of the osteopathic techniques, particularly by using physiological variables, and starting from a biomechanical angle. In fact, Jean-Pierre Barral and others has developed visceral manipulation techniques based on the viscera anatomy.

The originality of this research can be found in the technical protocol, not used yet, the use of witness group, the measurements over four weeks to evaluate the effect of this protocol with time on chosen dependant variables, its reproducibility but also its inter-therapist variance. This objective if this study is to reinforce the proof level of the osteopathic approach on the cardiac physiology. HRV is a solid tool recognized for research, the variable is well isolated and the control group ensures an isolation of some confounding variables.

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Key information

Age range

25 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Collège d'Études Ostéopathiques

Montreal, Quebec, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • man or woman
  • between 25 and 35 years old
  • healthy
  • non smoking

Exclusion criteria

  • diagnosed with anxiety or psychological disorder
  • smoker, drug consumption
  • diagnosed with renal disorder, cardiac disorder, functional somatic disorders, diabetes, chronic alcoholism, cancer or immunosuppressive disorders, stroke, aortic aneurysm,
  • pregnant
  • high level athletes
  • thoracic trauma or surgeries
  • does not fit Hexoskin vest for HRV measurements
  • does not complete all sessions
  • cannot stay lying down for 1 hour
  • below 25 or above 35 years old
  • student in manual therapy

Treatment and study plan

Osteopathic manipulative treatment

Other

Specific protocol including 4 osteopathic techniques targeting the pericardium

Sham therapy

Other

Sham therapy mimicking the osteopathic techniques applied to experimental group

Primary outcomes

  1. Heart rate variability

    Time frame: 45 minutes

    Real-time measurements of HRV before, during and after each intervention

Sponsors and collaborators

Lead sponsor

Université du Québec a Montréal

Other

Collaborators

  • Collège d'Études Ostéopathiques de Montreal

Registry information

Official study title

Études Des Effets d'un Protocol de thérapie Manuelle ostéopathique Sur la variabilité de la fréquence Cardiaque

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 21, 2020
Registry last updated
Jan 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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