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

NCT04234958 | Completed

• 1 other identifier: UQAMCEO_01
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

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

Keywords

heart rate variability; autonomous nervous system; osteopathy; osteopathy manipulative treatment; visceral; pericardium

Outcome Measures

Primary Outcomes (1)

• Heart rate variability

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

  45 minutes

Study Arms (3)

Experimental

EXPERIMENTAL

Participants received osteopathic treatment

Other: Osteopathic manipulative treatment

Sham

SHAM COMPARATOR

Participants received sham therapy

Other: Sham therapy

Control

NO INTERVENTION

Participants received no intervention

Interventions

Osteopathic manipulative treatment OTHER

Specific protocol including 4 osteopathic techniques targeting the pericardium

Experimental

Sham therapy OTHER

Sham therapy mimicking the osteopathic techniques applied to experimental group

Sham

Eligibility Criteria

• Age: 25 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Université du Québec a Montréal: lead
• Collège d'Études Ostéopathiques de Montreal: collaborator

Study Sites (1)

Collège d'Études Ostéopathiques

Montreal, Quebec, Canada

Location

MeSH Terms

Interventions

Manipulation, Osteopathic

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: randomized controlled trial

Study Record Dates

• First Submitted: January 15, 2020
• First Posted: January 21, 2020
• Study Start: March 15, 2017
• Primary Completion: January 17, 2018
• Study Completion: January 17, 2018
• Last Updated: January 22, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)