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

Study Overview
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Brief Summary
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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.

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

Conditions
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Respiratory Function Impaired

Intervention / Treatment
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* Other: Osteopathic Manipulative Medicine
* Other: Sham


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group<br> | Other: Osteopathic Manipulative Medicine<br>* Manipulative therapies based on Osteopathic principles.<br>|
| Sham Comparator: Sham Group<br> | Other: Sham<br>* Light touch techniques to mimic to osteopathic treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in chest wall excursion | 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) | 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) | 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 | 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 | 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 | 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) | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breathing Mechanics, Osteopathic Manipulative Treatment, Chest Wall Excursion, Pulmonary Function Tests