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

Not Applicable

Completed

• Conditions: Respiratory Function Impaired
• Interventions: Other: Osteopathic Manipulative Medicine; Other: Sham

• Registration Number: NCT04975542
• Lead Sponsor: Jayla Bostic

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-23
• Primary Completion: 2020-03-05
• Study Completion: 2020-03-05
• Study First Submitted: 2021-05-19
• Status Verified: 2021-07
• Study First Submitted QC: 2021-07-14
• Last Update Submitted: 2021-07-14
• Study First Posted: 2021-07-23
• Last Update Posted: 2021-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Group	Osteopathic Manipulative Medicine	-
Sham Group	Sham	-

Primary Outcome Measures

Name	Time	Method
Change in chest wall excursion	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).
Change in forced vital capacity (FVC)	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.
Change in forced expiratory volume at 1 second (FEV1)	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.
Change in FEV1/FVC ratio	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.

Secondary Outcome Measures

Name	Time	Method
Change in respiratory rate	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.
Change in heart rate	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).
Oxygen Saturation (spO2)	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.

Trial Locations

Locations (1)

Touro College of Osteopathic Medicine; 🇺🇸 New York, New York, United States