Back to resultsEfficacy of Osteopathic Manipulation on Breathing Mechanics in a Healthy Population: A Randomized Controlled Study
Primary Purpose
Respiratory Function Impaired
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Osteopathic Manipulative Medicine
Sham
Sponsored by
About this trial
This is an interventional treatment trial for Respiratory Function Impaired focused on measuring Breathing Mechanics, Osteopathic Manipulative Treatment, Chest Wall Excursion, Pulmonary Function Tests
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.
Sites / Locations
- Touro College of Osteopathic Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Treatment Group
Sham Group
Arm Description
Outcomes
Primary Outcome Measures
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).
Change in forced vital capacity (FVC)
Measurement of Forced Vital Capacity (FVC) as measured via pulmonary function testing.
Change in forced expiratory volume at 1 second (FEV1)
Measurement of Forced Expiratory Volume at 1 second (FEV1) as measured via pulmonary function testing.
Change in FEV1/FVC ratio
Measurement of a ratio between FEV1 and FVC values that are obtained through pulmonary function testing.
Secondary Outcome Measures
Change in respiratory rate
Measurement with a timer-based breath count with the units of breaths per minute.
Change in heart rate
Measurement with a noninvasive finger pulse-oximeter device with the units of beats per minute (bpm).
Oxygen Saturation (spO2)
Measurement with a noninvasive finger pulse-oximeter with the unit of spO2.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04975542
Brief Title
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
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
September 23, 2019 (Actual)
Primary Completion Date
March 5, 2020 (Actual)
Study Completion Date
March 5, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jayla Bostic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Function Impaired
Keywords
Breathing Mechanics, Osteopathic Manipulative Treatment, Chest Wall Excursion, Pulmonary Function Tests
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment Group
Arm Type
Experimental
Arm Title
Sham Group
Arm Type
Sham Comparator
Intervention Type
Other
Intervention Name(s)
Osteopathic Manipulative Medicine
Intervention Description
Manipulative therapies based on Osteopathic principles.
Intervention Type
Other
Intervention Name(s)
Sham
Intervention Description
Light touch techniques to mimic to osteopathic treatment.
Primary Outcome Measure Information:
Title
Change in chest wall excursion
Description
M1 and M2 measurements with a soft tape measure. M1: Level of sternal notch (in centimeters), M2: Level of xiphoid process (in centimeters).
Time Frame
Measure assessing a change from baseline chest wall excursion within 5 minutes of treatment completion.
Title
Change in forced vital capacity (FVC)
Description
Measurement of Forced Vital Capacity (FVC) as measured via pulmonary function testing.
Time Frame
Measure assessing a change from baseline FVC value via pulmonary function testing within 5 minutes of treatment completion.
Title
Change in forced expiratory volume at 1 second (FEV1)
Description
Measurement of Forced Expiratory Volume at 1 second (FEV1) as measured via pulmonary function testing.
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.
Title
Change in FEV1/FVC ratio
Description
Measurement of a ratio between FEV1 and FVC values that are obtained through pulmonary function testing.
Time Frame
Measure assessing a change from baseline FEV1/FVC ratio value via pulmonary function testing within 5 minutes of treatment completion.
Secondary Outcome Measure Information:
Title
Change in respiratory rate
Description
Measurement with a timer-based breath count with the units of breaths per minute.
Time Frame
Measure assessing a change from baseline respiratory rate within 5 minutes of treatment completion.
Title
Change in heart rate
Description
Measurement with a noninvasive finger pulse-oximeter device with the units of beats per minute (bpm).
Time Frame
Measure assessing a change from baseline heart rate within 5 minutes of treatment completion.
Title
Oxygen Saturation (spO2)
Description
Measurement with a noninvasive finger pulse-oximeter with the unit of spO2.
Time Frame
Measure assessing a change from baseline oxygen saturation within 5 minutes of treatment completion.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mikhail Volokitin, MD, DO
Organizational Affiliation
Touro College of Osteopathic Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Touro College of Osteopathic Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10027
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
15083985
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.
Results Reference
background
PubMed Identifier
22305244
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.
Results Reference
background
PubMed Identifier
15710659
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.
Results Reference
background
PubMed Identifier
27794081
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.
Results Reference
background
PubMed Identifier
30741314
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.
Results Reference
background
Learn more about this trial
Efficacy of Osteopathic Manipulation on Breathing Mechanics in a Healthy Population: A Randomized Controlled Study
We'll reach out to this number within 24 hrs