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

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

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.

Study Overview

• Status: Completed
• Conditions: Heart Rate Variability
• Intervention / Treatment: Other: Osteopathic manipulative treatment; Other: Sham therapy

• Study Type: Interventional
• Enrollment (Actual): 162
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada
      • Collège d'Études Ostéopathiques

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 35 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Experimental; Participants received osteopathic treatment	Other: Osteopathic manipulative treatment; Specific protocol including 4 osteopathic techniques targeting the pericardium
SHAM_COMPARATOR: Sham; Participants received sham therapy	Other: Sham therapy; Sham therapy mimicking the osteopathic techniques applied to experimental group
NO_INTERVENTION: Control; Participants received no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate variability	Real-time measurements of HRV before, during and after each intervention	45 minutes

Collaborators and Investigators

• Sponsor: Université du Québec a Montréal
• Collaborators: Collège d'Études Ostéopathiques de Montreal

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 15, 2017
• Primary Completion (ACTUAL): January 17, 2018
• Study Completion (ACTUAL): January 17, 2018

Study Registration Dates

• First Submitted: January 15, 2020
• First Submitted That Met QC Criteria: January 17, 2020
• First Posted (ACTUAL): January 21, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 22, 2020
• Last Update Submitted That Met QC Criteria: January 19, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: heart rate variability; osteopathy; visceral; autonomous nervous system; osteopathy manipulative treatment; pericardium
• Other Study ID Numbers: UQAMCEO_01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No