Clinical trial NCT04975542: Efficacy of Osteopathic Manipulation on Breathing Mechanics in a Healthy Population: A Randomized Controlled Study
Official title: Efficacy of Osteopathic Manipulation on Breathing Mechanics in a Healthy Population: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Function Impaired
Keywords: Breathing Mechanics
Osteopathic Manipulative Treatment
Chest Wall Excursion
Pulmonary Function Tests
Lead sponsor: The Touro College and University System
Sponsor class: OTHER
First posted: 2021-07-23
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in chest wall excursion
timeFrame: Measure assessing a change from baseline chest wall excursion within 5 minutes of treatment completion.
measure: Change in forced vital capacity (FVC)
timeFrame: Measure assessing a change from baseline FVC value via pulmonary function testing within 5 minutes of treatment completion.
measure: Change in forced expiratory volume at 1 second (FEV1)
timeFrame: Measure assessing a change from baseline in forced expiratory volume at 1 second via pulmonary function testing within 5 minutes of treatment completion.
measure: Change in FEV1/FVC ratio
timeFrame: Measure assessing a change from baseline FEV1/FVC ratio value via pulmonary function testing within 5 minutes of treatment completion.
Secondary outcomes:
measure: Change in respiratory rate
timeFrame: Measure assessing a change from baseline respiratory rate within 5 minutes of treatment completion.
measure: Change in heart rate
timeFrame: Measure assessing a change from baseline heart rate within 5 minutes of treatment completion.
measure: Oxygen Saturation (spO2)
timeFrame: Measure assessing a change from baseline oxygen saturation within 5 minutes of treatment completion.
Other outcomes:
Locations:
city: New York
country: United States
facility: Touro College of Osteopathic Medicine
state: New York
Study officials:
affiliation: Touro College of Osteopathic Medicine
name: Mikhail Volokitin, MD, DO
role: STUDY_DIRECTOR
References:
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. No abstract available.
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.
citation: 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.
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. doi: 10.4187/respcare.04742. Epub 2016 Oct 18.
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. Online ahead of print.