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Completed

NCT Number: NCT04975542

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

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.

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Key information

Conditions

Respiratory Function Impaired Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Touro College of Osteopathic Medicine

New York, 10027, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Osteopathic Manipulative Medicine

Other

Manipulative therapies based on Osteopathic principles.

SHAM

Other

Light touch techniques to mimic to osteopathic treatment.

Primary outcomes

  1. 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).

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. 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.

  2. 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).

  3. 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.

Sponsors and collaborators

Lead sponsor

Jayla Bostic

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 23, 2021
Registry last updated
Jul 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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