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

Respiratory Function Impaired Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04975542
• Other study ID #: T2022
• Status: Completed
• Phase: N/A
• Start date: September 23, 2019
• Est. completion date: March 5, 2020

Study information

• Verified date: July 2021
• Source: The Touro College and University System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: March 5, 2020
• Est. primary completion date: March 5, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Respiratory Aspiration
• Respiratory Function Impaired
• Respiratory Insufficiency

Intervention

Other:
• Osteopathic Manipulative Medicine
Manipulative therapies based on Osteopathic principles.
• Sham
Light touch techniques to mimic to osteopathic treatment.

Locations

Country	Name	City	State
United States	Touro College of Osteopathic Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Jayla Bostic

Country where clinical trial is conducted

United States, 

References & Publications (5)

Guiney PA, Chou R, Vianna A, Lovenheim J. Effects of osteopathic manipulative treatment on pediatric patients with asthma: a randomized controlled trial. J Am Osteopath Assoc. 2005 Jan;105(1):7-12. — View Citation

Kaneko H, Shiranita S, Horie J, Hayashi S. Reduced Chest and Abdominal Wall Mobility and Their Relationship to Lung Function, Respiratory Muscle Strength, and Exercise Tolerance in Subjects With COPD. Respir Care. 2016 Nov;61(11):1472-1480. Epub 2016 Oct 18. — View Citation

Lorenzo S, Nicotra CM, Mentreddy AR, Padia HJ, Stewart DO, Hussein MO, Quinn TA. Assessment of Pulmonary Function After Osteopathic Manipulative Treatment vs Standard Pulmonary Rehabilitation in a Healthy Population. J Am Osteopath Assoc. 2019 Feb 11. doi: 10.7556/jaoa.2019.026. [Epub ahead of print] — View Citation

Noll DR, Degenhardt BF, Stuart M, McGovern R, Matteson M. Effectiveness of a sham protocol and adverse effects in a clinical trial of osteopathic manipulative treatment in nursing home patients. J Am Osteopath Assoc. 2004 Mar;104(3):107-13. — View Citation

Zanotti E, Berardinelli P, Bizzarri C, Civardi A, Manstretta A, Rossetti S, Fracchia C. Osteopathic manipulative treatment effectiveness in severe chronic obstructive pulmonary disease: a pilot study. Complement Ther Med. 2012 Feb-Apr;20(1-2):16-22. doi: 10.1016/j.ctim.2011.10.008. Epub 2011 Nov 27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.