Efficacy of Osteopathic Manipulation on Breathing Mechanics in a Healthy Population: A Randomized Controlled Study

July 14, 2021 updated by: Jayla Bostic
This study focused on improving breathing mechanics by using various osteopathic manipulative therapy (OMT) techniques. The investigators randomly assigned participants to a control group who received sham treatment and a treatment group who received OMT. The investigators measured variable pre- and post- treatment on both groups. The investigators observed an improvement in breathing mechanics in the treatment group.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10027
        • Touro College of Osteopathic Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy volunteers from Touro College of Osteopathic Medicine (TouroCOM), including students and staff, were recruited as subjects of this study. Any participant with recent or past medical history of obstructive or restrictive lung disorders, recent trauma, or illnesses, and/or chest abnormalities were excluded from the study.

Exclusion Criteria:

  • Certain study results were excluded on the basis of abnormal baseline measurements, including but not limited to, heart rate, oxygen saturation, respiratory rate, improper spirometer use, technique and/or high variance among the repeated measurements obtained for each participant.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Treatment Group
Other: Osteopathic Manipulative Medicine
Manipulative therapies based on Osteopathic principles.
SHAM_COMPARATOR: Sham Group
Other: Sham
Light touch techniques to mimic to osteopathic treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in chest wall excursion
Time Frame: Measure assessing a change from baseline chest wall excursion within 5 minutes of treatment completion.
M1 and M2 measurements with a soft tape measure. M1: Level of sternal notch (in centimeters), M2: Level of xiphoid process (in centimeters).
Measure assessing a change from baseline chest wall excursion within 5 minutes of treatment completion.
Change in forced vital capacity (FVC)
Time Frame: Measure assessing a change from baseline FVC value via pulmonary function testing within 5 minutes of treatment completion.
Measurement of Forced Vital Capacity (FVC) as measured via pulmonary function testing.
Measure assessing a change from baseline FVC value via pulmonary function testing within 5 minutes of treatment completion.
Change in forced expiratory volume at 1 second (FEV1)
Time Frame: Measure assessing a change from baseline in forced expiratory volume at 1 second via pulmonary function testing within 5 minutes of treatment completion.
Measurement of Forced Expiratory Volume at 1 second (FEV1) as measured via pulmonary function testing.
Measure assessing a change from baseline in forced expiratory volume at 1 second via pulmonary function testing within 5 minutes of treatment completion.
Change in FEV1/FVC ratio
Time Frame: Measure assessing a change from baseline FEV1/FVC ratio value via pulmonary function testing within 5 minutes of treatment completion.
Measurement of a ratio between FEV1 and FVC values that are obtained through pulmonary function testing.
Measure assessing a change from baseline FEV1/FVC ratio value via pulmonary function testing within 5 minutes of treatment completion.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in respiratory rate
Time Frame: Measure assessing a change from baseline respiratory rate within 5 minutes of treatment completion.
Measurement with a timer-based breath count with the units of breaths per minute.
Measure assessing a change from baseline respiratory rate within 5 minutes of treatment completion.
Change in heart rate
Time Frame: Measure assessing a change from baseline heart rate within 5 minutes of treatment completion.
Measurement with a noninvasive finger pulse-oximeter device with the units of beats per minute (bpm).
Measure assessing a change from baseline heart rate within 5 minutes of treatment completion.
Oxygen Saturation (spO2)
Time Frame: Measure assessing a change from baseline oxygen saturation within 5 minutes of treatment completion.
Measurement with a noninvasive finger pulse-oximeter with the unit of spO2.
Measure assessing a change from baseline oxygen saturation within 5 minutes of treatment completion.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jayla Bostic

Investigators

  • Study Director: Mikhail Volokitin, MD, DO, Touro College of Osteopathic Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 23, 2019

Primary Completion (ACTUAL)

March 5, 2020

Study Completion (ACTUAL)

March 5, 2020

Study Registration Dates

First Submitted

May 19, 2021

First Submitted That Met QC Criteria

July 14, 2021

First Posted (ACTUAL)

July 23, 2021

Study Record Updates

Last Update Posted (ACTUAL)

July 23, 2021

Last Update Submitted That Met QC Criteria

July 14, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T2022

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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