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

NCT ID: NCT04234958

Last Updated: 2020-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 162 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-15
• Study Completion Date: 2018-01-17

Brief Summary

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.

Conditions

Heart Rate Variability

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Experimental

Participants received osteopathic treatment

Group Type: EXPERIMENTAL

Osteopathic manipulative treatment

Intervention Type: OTHER

Specific protocol including 4 osteopathic techniques targeting the pericardium

Sham

Participants received sham therapy

Group Type: SHAM_COMPARATOR

Sham therapy

Intervention Type: OTHER

Sham therapy mimicking the osteopathic techniques applied to experimental group

Control

Participants received no intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Osteopathic manipulative treatment

Specific protocol including 4 osteopathic techniques targeting the pericardium

Intervention Type: OTHER

Sham therapy

Sham therapy mimicking the osteopathic techniques applied to experimental group

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Collège d'Études Ostéopathiques de Montreal

UNKNOWN

Sponsor Role: collaborator

Université du Québec a Montréal

OTHER

Sponsor Role: lead

Responsible Party

Alain Steve Comtois

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Collège d'Études Ostéopathiques

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

UQAMCEO_01

Identifier Type: -

Identifier Source: org_study_id