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

NCT ID: NCT04975542

Last Updated: 2021-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-23

Study Completion Date

2020-03-05

Brief Summary

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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.

Detailed Description

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Conditions

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Respiratory Function Impaired

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Treatment Group

Group Type EXPERIMENTAL

Osteopathic Manipulative Medicine

Intervention Type OTHER

Manipulative therapies based on Osteopathic principles.

Sham Group

Group Type SHAM_COMPARATOR

Sham

Intervention Type OTHER

Light touch techniques to mimic to osteopathic treatment.

Interventions

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Osteopathic Manipulative Medicine

Manipulative therapies based on Osteopathic principles.

Intervention Type OTHER

Sham

Light touch techniques to mimic to osteopathic treatment.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Jayla Bostic

OTHER

Sponsor Role lead

Responsible Party

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Jayla Bostic

Medical Student

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Mikhail Volokitin, MD, DO

Role: STUDY_DIRECTOR

Touro College of Osteopathic Medicine

Locations

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Touro College of Osteopathic Medicine

New York, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 15083985 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22305244 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15710659 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27794081 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30741314 (View on PubMed)

Other Identifiers

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T2022

Identifier Type: -

Identifier Source: org_study_id

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