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

NCT04975542 | Completed

• 1 other identifier: T2022
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Function Impaired

Keywords

Breathing Mechanics; Osteopathic Manipulative Treatment; Chest Wall Excursion; Pulmonary Function Tests

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Change in respiratory rate

  Measure assessing a change from baseline respiratory rate within 5 minutes of treatment completion.

• Change in heart rate

  Measure assessing a change from baseline heart rate within 5 minutes of treatment completion.

• Oxygen Saturation (spO2)

  Measure assessing a change from baseline oxygen saturation within 5 minutes of treatment completion.

Study Arms (2)

Treatment Group

EXPERIMENTAL

Other: Osteopathic Manipulative Medicine

Sham Group

SHAM COMPARATOR

Other: Sham

Interventions

Osteopathic Manipulative Medicine OTHER

Manipulative therapies based on Osteopathic principles.

Treatment Group

Sham OTHER

Light touch techniques to mimic to osteopathic treatment.

Sham Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jayla Bostic: lead

Study Sites (1)

Touro College of Osteopathic Medicine

New York, New York, 10027, United States

Location

Related Publications (5)

• 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.

  PMID: 15083985 BACKGROUND

• 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.

  PMID: 22305244 BACKGROUND

• 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.

  PMID: 15710659 BACKGROUND

• 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.

  PMID: 27794081 BACKGROUND

• 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.

  PMID: 30741314 BACKGROUND

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Mikhail Volokitin, MD, DO

  Touro College of Osteopathic Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Student

Study Record Dates

• First Submitted: May 19, 2021
• First Posted: July 23, 2021
• Study Start: September 23, 2019
• Primary Completion: March 5, 2020
• Study Completion: March 5, 2020
• Last Updated: July 23, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)